Abstract
Abstract
Background:
The aim of this study was to compare the surgical outcome of day-case laparoscopic cholecystectomy (DCLC) performed with the patient under spinal anesthesia with that performed with the patients under general anesthesia in the management of symptomatic uncomplicated gallstone disease.
Patients and
Results:
In both groups, all procedures were completed laparoscopically. In the SA-DCLC group, there were 4 (4.4%) anesthetic conversions due to intolerable right shoulder pain, and those 4 patients were excluded from further analysis. In the SA-DCLC group, all patients were discharged on the same day. Overnight stay was required in 8 patients (8.9%) in the GA-DCLC group (P<.001). The cause of overnight stay was nausea and vomiting in 4 patients (4.4%), inadequate pain control in 3 patients (3.3%), and unexplained hypotension in 1 patient (1.1%). Readmission was required in 1 patient (1.1%) in the GA-DCLC group. The difference in patient satisfaction scores with regard to both anesthetic technique and same-day discharge was not statistically significant between the two groups studied.
Conclusions:
DCLC performed with the patient under spinal anesthesia is feasible and safe and is associated with less postoperative pain and lower incidence of postoperative nausea and vomiting and therefore a lower incidence of overnight stay compared with that performed with the patient under general anesthesia.
Introduction
Adequate pain relief is an important aspect of day-case surgery. Various methods have been attempted to decrease postoperative pain following LC such as peritoneal instillation of normal saline or local anesthetic and wound infiltration with local anesthetic.8,9 Spinal anesthesia is a less invasive anesthetic technique that has lower morbidity and mortality rates, compared with general anesthesia. 10 Furthermore, spinal anesthesia offers several advantages over general anesthesia. 10 First, the patient is awake and oriented at the end of the procedure. Second, the immediate postoperative period is viewed positively by patients because of the absence of general anesthetic side effects (e.g., nausea and vomiting) and less pain experienced due to the effect of persistent neuraxial blockage. Third, patients who have received spinal anesthesia tend to ambulate earlier than patients receiving general anesthesia. 10 Finally, pain related to intubation and/or extubation can be prevented by administering selective spinal anesthesia to patients undergoing laparoscopic interventions. 11 Several studies have demonstrated that LC with the patient under spinal anesthesia was feasible and safe and was associated with better postoperative pain control.12–17 The aim of this prospective randomized study was to compare the surgical outcome of day-case LC performed with the patient under spinal anesthesia with that of day-case LC performed with the patient under general anesthesia in the management of symptomatic uncomplicated gallstone disease.
Patients and Methods
The study was approved by the Ethics Committees of both the General Surgery Department and the Faculty of Medicine of the University of Alexandria, Alexandria, Egypt. An informed consent was obtained from all patients who agreed to participate in the study after receiving a thorough explanation of the procedure and the benefits and risks involved. Inclusion criteria for LC included patients with uncomplicated symptomatic gallstones disease complying with American Society of Anesthesiologists grade I or II. Patients presenting with abnormal serum bilirubin, alkaline phosphatase, and gamma-glutamyltransferase levels and/or a maximum common bile duct diameter of>5 mm on preoperative ultrasonography were referred initially for endoscopic retrograde cholangiopancreatography for diagnosis and subsequent management. Consequently, no intraoperative cholangiograms were performed. Exclusion criteria included patients with acute cholecystitis, suspicion of gallbladder malignancy based on ultrasonography and subsequent computed tomography findings, previous upper abdominal surgery, and pregnancy.
Inclusion criteria for day-case surgery included age≤50 years, absence of co-morbidities requiring extra monitoring during the postoperative period, body mass index<35 kgm/m2, residence within the city of Alexandria, and the ability to provide a responsible caregiver who would be in attendance during the first 24 hours postoperatively. Patients were placed as the first and second cases on the morning operating list, and surgery was performed before 12:00 hours. Day-case surgery was defined as discharge before 20:00 hours the same day.
Following preoperative evaluation and preparation for surgery, patients were randomly assigned using the sealed envelope technique to either the spinal anesthesia day-case LC (SA-DCLC) group) or the general anesthesia day-case LC (GA-DCLC) group.
The technique for spinal anesthesia was as follows. Upon patients' arrival at the operating theater and after establishing noninvasive monitoring (electrocardiogram, arterial blood pressure, and pulse oximetry), an arterial line was inserted for direct blood pressure monitoring and blood sampling. All patients received intravenously 500 mL of Ringer's lactate solution, 1 mg of midazolam, 4 mg of ondansetron, and 50 mg of ranitidine. With the patient at the sitting position, a 25-gauge pencil-point spinal needle was introduced into the subarachnoid space at the L2–3 intervertebral space under strict aseptic conditions. After free flow of cerebrospinal fluid, 3 mL containing hyperbaric bupivacaine (0.5%) and 20 μg of fentanyl was injected intrathecally. The patient was next placed in the supine position, remaining in the Trendelenburg position for 3 minutes. The sensory level, which was accepted as the T4 dermatome level to allow LC, was tested using temperature sensation. A decrease in the mean arterial blood pressure by more than 20% below the pre-anesthetic level was managed in the standard manner (i.e., intermittent incremental intravenous doses of 5 mg of ephedrine were started and titrated to effect). Alternatively, the technique of general anesthesia went as follows. Induction was achieved using propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5 mg/kg), and an endotracheal tube was inserted after 3 minutes of face mask ventilation with isoflurane in 100% oxygen. Maintenance was achieved using isoflurane (1–1.5% concentration), increments of muscle relaxant, and controlled mechanical ventilation. All patients received 4 mg of ondansetron after induction.
All patients received prophylactic perioperative intravenous antibiotics (a third-generation cephalosporin and metronidazole). Obese patients received prophylactic perioperative low-molecular-weight heparin. A uniform technique of LC was applied, including the use of standard four-trocar technique, the creation of a carbon dioxide pneumoperitoneum using an optical trocar without prior insufflation, and a 0° optical scope. Dissection of the gallbladder was initiated at the triangle of Calot with identification and skeletonization of both the cystic duct and the artery. Mobilization of the gallbladder from the liver bed started posteriorly at the triangle of Calot and proceeded anteriorly. Following removal of the gallbladder, a subhepatic drain was routinely placed. In the GA-DCLC group, the patient was placed in the supine, reverse Trendelenburg position, with the arms fully abducted and the right shoulder elevated. Pneumoperitoneum was established to a maximum of 15 mm Hg. In the SA-DCLC group, the following two modifications were applied: pneumoperitoneum was set at a lower pressure of 10 mm Hg, and minimal tilt of the patient was used (i.e., minimal use of both reverse Trendelenburg positioning and right shoulder elevation). In the SA-DCLC group, nasogastric intubation was not used unless gastric dilatation obscuring the operative field was encountered.
The operative time was recorded by an independent observer. Intraoperative incidents related to the anesthetic technique (e.g., right shoulder pain, hypotension, nausea, and/or vomiting) were documented. Postoperatively, pain was assessed using a Visual Analog Scale from 0 to 10, with 10 being most severe. Patients were asked to score their pain at 2, 4, 6, and 8 hours postoperatively. A median score was determined for each group at each time measurement, and an overall 8-hour postoperative median score was obtained for each group. Furthermore, patients were allowed intramuscular injections of diclofenac potassium (75 mg) as needed, and the number of ampules administered to each patient during the first 8 hours postoperatively was recorded. The subhepatic drain was removed 8 hours postoperatively prior to discharge. Postoperative complications, overnight stay, and readmissions were recorded. Patients were discharged if they were ambulatory, tolerating oral fluids, and expressing no excessive pain, nausea, or vomiting by the eighth postoperative hour and if the operation was without complications. In addition, patients were given the phone number of the attending surgeon who performed the operation so as to call with questions or problems during the first 24 hours postoperatively.
Follow-up was performed at the end of the first and fourth postoperative weeks by history taking and clinical examination. At the end of the first postoperative week, patient satisfaction as to the anesthetic technique they received was assessed using the score ranging from 0 to 10 described by Hamad and Ibrahim El-Khattary. 12 Scores ranging from 0 to 2.5 were considered “unsatisfactory,” those ranging from 2.5 to 5 were considered “neutral,” those ranging from 5 to 7.5 were considered “satisfactory,” and those ranging from 7.5 to 10 were considered “very good.” 12 In addition, patient satisfaction as to day-case surgery was assessed using a 4-point scale scored as follows: 1=not satisfied, 2=satisfied, 3=good, 4=excellent.
Sample size calculation was based on earlier results from a prospective randomized clinical trial conducted at our institution comparing the surgical outcomes of LC performed with the patient under general anesthesia with those of LC performed with the patient under spinal anesthesia. 17 Initial power calculations suggested that at minimum 88 patients were required in each group to achieve statistical significance with a power of 80% at a 5% level of significance. All data analysis was performed with Statistical Package for the Social Sciences version 18 software (SPSS, Chicago, IL). The Mann–Whitney U test and Student's t test were used for continuous variables. The chi-squared and Fisher's exact tests were used for categorical variables. All P values were two-sided. A value of P<.05 was considered statistically significant.
Results
From January 2010 through December 2011, 180 patients were operated upon. There were 161 females (89.4%) and 19 males (10.6%). Their ages ranged from 16 to 50 years with a median of 42 years. Following preoperative evaluation and preparation for surgery, patients were randomly assigned using the sealed-envelope technique to either one of two groups: the GA-DCLC group (90 patients) and the SA-DCLC group (90 patients). There was no statistically significant difference between both groups studied regarding age and sex distribution, median body mass index, and percentage of obese patients as shown in Table 1.
BMI, body mass index; GA-DCLC, general anesthesia day-case laparoscopic cholecystectomy; SA-DCLC, spinal anesthesia day-case laparoscopic cholecystectomy.
In both groups, all procedures were completed laparoscopically, and there were no surgical conversions. In the SA-DCLC group, there were 4 (4.4%) anesthetic conversions due to intolerable intraoperative right shoulder pain, and those 4 patients were excluded from further assessment because they received spinal followed by general anesthesia. In the GA-DCLC group, the operative time ranged from 19 to 75 minutes, with a median of 35 minutes, whereas in the SA-DCLC group, the operative time ranged from 20 to 78 minutes, with a median of 35 minutes (P=.427).
Intraoperatively, in the SA-DCLC group, right shoulder pain was encountered in 32 patients (35.6%). In 8 patients (8.9%), the pain was mild and transient at the start of the procedure and did not necessitate any intervention. In 20 patients (22.2%), however, intravenous fentanyl was required for the relief of this pain. In the remaining 4 patients (4.4%), failure to control this pain necessitated conversion to general anesthesia. Hypotension was encountered in 29 patients (32.2%) and was managed by intravenous ephedrine.
The postoperative pain scores encountered in both groups studied are shown in Table 2. At 2 and 4 hours postoperatively, the median pain score encountered on the Visual Analog Scale in the SA-DCLC group was statistically significantly lower than that encountered in the GA-DCLC group (P<.001). Although the median pain scores encountered at 6 and 8 hours postoperatively did not show any statistically significant difference between both groups studied, however, for the first 8 hours postoperatively, the median pain score in the SA-DCLC group was statistically significantly lower than that in the GA-DCLC group (P<.001).
Difference statistically significant.
In the GA-DCLC group, the postoperative analgesic ampules required per patient ranged from 1 to 2, with a median of 2 ampules per patient. On the other hand, the required number of ampoules ranged from 0 to 2 ampules in the SA-DCLC group, with a median of 0 ampules per patient. This difference in the median number of analgesic ampules required per patient in the first 8 hours postoperatively was statistically significant (P<.001). In the SA-DCLC group, 49 patients (57%) required no analgesic ampules, and none of the patients required analgesia within the first 4 hours postoperatively.
The postoperative complications encountered in both groups studied are illustrated in Table 3. No statistically significant difference was found in the incidence of postoperative complications encountered in both groups studied, except for the statistically significant higher incidence of postoperative nausea and vomiting (PONV) in the GA-DCLC group (P=.004).
Difference statistically significant.
In the SA-DCLC group, all patients were discharged on the same day. In contrast, overnight stay was required in 8 patients (8.9%) in the GA-DCLC group. The difference in the incidence of overnight stay between both groups studied was statistically significant (P<.001). In the GA-DCLC group, the cause of overnight stay was nausea and vomiting in 4 patients (4.4%), inadequate pain control in 3 patients (3.3%), and unexplained hypotension in 1 patient (1.1%). It is noteworthy that the 4 patients (4.4%) in whom intolerable intraoperative right shoulder pain necessitated conversion from spinal to general anesthesia were all discharged on the same day of LC. Readmission was required in 1 patient (1.1%) in the GA-DCLC group 1 week postoperatively because of a missed common bile duct stone that was successfully extracted by endoscopic retrograde cholangiopancreatography.
Patient satisfaction regarding the particular use of anesthesia was estimated at the end of the first postoperative week by direct patient questionnaire. In the SA-DCLC group, the satisfaction scores ranged from 6 to 10, with a median score of 10. Eight patients (9.3%) considered the technique satisfactory, and 78 patients (90.7%) considered the technique “very good.” In the GA-DCLC group, the satisfaction scores ranged from 5 to 10, with a median score of 10 (P=.091). Five patients (5.6%) considered the technique satisfactory, and 85 patients (94.4%) considered the technique “very good.”
Patient satisfaction regarding day-case surgery was also estimated at the end of the first postoperative week by direct patient questionnaire. In the SA-DCLC group, the satisfaction scores ranged from 3 to 4 with a median score of 4. Six patients (7%) considered such policy to be “good,” whereas 80 patients (93%) considered it to be “excellent.” In the GA-DCLC group, the satisfaction scores ranged from 3 to 4 with a median score of 4 (P=.674). Six patients (7.3%) considered such policy to be “good,” whereas 76 patients (92.7%) considered it to be “excellent.”
Discussion
The main finding of the present study was that DCLC performed with the patient under spinal anesthesia is as feasible and as safe as that performed with the patient under general anesthesia. In addition, DCLC performed with the patient under spinal anesthesia is associated with significantly less postoperative pain, lower incidence of PONV, and lower incidence of overnight stay compared with that performed with the patient under general anesthesia.
Earlier studies have demonstrated the feasibility and safety of LC performed in the medically fit patient under spinal anesthesia.12–17 Specific intraoperative events related to spinal anesthesia included hypotension and right shoulder pain. In the present study, intraoperative hypotension was encountered in 29 patients (32.2%). As pointed out by Tzovaras et al., 15 intraoperative hypotension is a well-known adverse effect of spinal anesthesia that was easily managed and did not affect the planed procedure. The reported incidence of intraoperative right shoulder pain requiring intravenous fentanyl administration in previous studies ranged from 10% to 55.2%.12–17 In the present study intraoperative right shoulder pain requiring intravenous fentanyl administration was encountered in 24 patients (26.7%). In earlier studies, the absence of anesthetic conversion due to intolerable right shoulder pain failing to respond to intravenous fentanyl administration has been associated with the combined use of low-pressure pneumoperitoneum (the intra-abdominal pressure was kept at 8–11 mm Hg) and minimal positional changes (i.e., minimal reverse Trendelenburg and minimal right shoulder elevation).13,15,17 Such maneuvers aimed at diminishing irritation of the unanesthetized diaphragm by the insufflating gas, therefore diminishing the incidence and/or severity of right shoulder pain and consequently abolishing the need for anesthetic conversion. Despite the adoption of such maneuvers in the present study, conversion to general anesthesia was required in 4 patients (4.4%). The results of the present study suggest that such maneuvers may assist in lowering the incidence and/or severity of intraoperative right shoulder pain necessitating anesthetic conversion; however, they may not provide a complete safeguard against anesthetic conversion. It is noteworthy that additional maneuvers including the use of nitrous oxide (which is less of an irritant to the parietal peritoneum than carbon dioxide) as the insufflating gas and the additional spraying of the diaphragm with 2% lidocaine solution did not provide a complete safeguard against anesthetic conversion as demonstrated by others.12,14 In the present study, failure to complete LC with the patient under spinal anesthesia in 4 patients (4.4%) due to intolerable intraoperative right shoulder pain not responding intravenous fentanyl administration was easily managed by conversion to general anesthesia, which abolished the pain and allowed for completion of the procedure laparoscopically. Furthermore, this anesthetic conversion did not preclude same-day discharge in any of the patients, at least in the present study.
Adherence to strict criteria for patient selection for DCLC has achieved a success rate of over 90% in earlier studies.18,19 The success rate for day-case surgery dropped to 70% when strict criteria were not adhered to, and the factors blamed included age older than 50 years and American Society of Anesthesiologists class III or more. 20 Although others were able to achieve higher success rates with more relaxed criteria of patient selection, however, adherence to strict criteria for patient selection while exploring the feasibility, safety, and efficacy of spinal anesthesia for DCLC was thought mandatory in the initial evaluation of this approach. 21 In the present study, DCLC was successful in 100% of patients in the SA-DCLC group. Whether these results are reproducible or not using more relaxed criteria of patient selection for DCLC with spinal anesthesia awaits the results of further studies addressing this particular issue.
The reported incidence of overnight stay following planned DCLC in some earlier studies ranged from 0% to 26.1%.4–7,22–25 In the present study, overnight stay was required in 8.9% of the patients in the GA-DCLC group and in no patient in the SA-DCLC group. This difference in the incidence of overnight stay between both groups studied was statistically significant. Various reasons have been reported for failure of same-day discharge, including inadequate control of postoperative pain, inadequate control of PONV, conversion to open procedure, complicated procedures, and additional procedures (e.g., common bile duct exploration), among others.4–7,22–25
Postoperative pain management remains a key issue for the success of DCLC. Keulemans et al. 22 found that postoperative pain was the primary reason for both delayed discharge and prolonged convalescence following ambulatory LC. In the present study, the median pain scores encountered at 2 and 4 hours postoperatively were statistically significantly lower in the SA-DCLC group. Although the median pain scores encountered at 6 and 8 hours postoperatively did not show any statistically significant difference between both groups studied, the median pain score for the first 8 hours postoperatively remained statistically significantly lower in the SA-DCLC group. In addition, the median number of analgesic ampules required per patient was statistically significantly lower in the SA-DCLC group. Similar results have been reported in earlier studies comparing between spinal and general anesthesia for LC.13,15,17 Furthermore, Tzovaras et al. 13 reported a statistically significant lower incidence of patients receiving supplementary postoperative opioid analgesia in the spinal anesthesia group compared with the general anesthesia group (2% versus 25%, respectively; P<.001). In the present study, overnight stay was required in 3 patients (3.3%) in the GA-DCLC group because of inadequate pain control compared with no patient in the SA-DCLC group.
PONV, a complication of general anesthesia, is a complex multifactorial problem where predisposition of the patient, type of operation, types of anesthetic agent, use of postoperative opioids, fluid administration pre- and intraoperatively, and the judicious use of antiemetics all play a part.26–30 Methods used to prevent PONV included the use of premedications including antiemetics and dexamethasone as well as avoiding the use of volatile anesthetic agents and the injudicious use of opiates in the postoperative period.26–30 However, there has been no consensus on the premedications and the anesthetic drug regimens with others maintaining their standard anesthetic protocols with comparable results.4,23,31 Overnight stay due to PONV has been found to vary from 1% to 7% in some earlier studies.32–38 In the present study as well as in earlier studies, the use of spinal anesthesia has been associated with a statistically significant lower incidence of PONV.13,15,17 Overnight stay due to PONV was required in 4 patients (4.4%) in the GA-DCLC group compared with none in the SA-DCLC group.
Operative complications and conversion to open procedure are well-documented causes for failure of same-day discharge. 4 The absence of both events in the present study may suggest two conclusions: first, the importance of patient selection for DCLC; and second, the combined use of low-pressure pneumoperitoneum and minimal positional changes did not jeopardize either the adequacy of the intra-abdominal working space or the operative view. Additional evidence come from the absence of a statistically significant difference in the median/mean operative time between both groups studied in the present article as well as in earlier ones.15,17
Apart from the statistically significant higher incidence of PONV encountered in the GA-DCLC group, no statistically significant difference was found in the incidence of postoperative complications encountered in both groups studied. Two complications specific to the use of spinal anesthesia were encountered in the present study, namely, post-spinal headache and postoperative urine retention. Post-spinal headache was encountered in 3 patients (3.5%) in the SA-DCLC group. Sinha et al. 16 reported post-spinal headache in 206 patients (5.9%). The reported incidence of postoperative urine retention in previous studies ranged from 0.29% to 6.7%.12–17 In the present study postoperative urine retention was encountered in 1 patient (1.2%). Both complications necessitated neither overnight stay nor readmission.
The reported incidence for readmissions following DCLC in some earlier studies ranged from 0% to 4.7%.4–7,22–25 Common bile duct stones have been a well-documented cause of readmissions following DCLC. 39 In the present study, readmission was required in 1 patient (1.1%) in the GA-DCLC group because of retained common bile duct stones that were successfully managed by endoscopic retrograde cholangiopancreatography.
In the present study, there was no statistically significant difference between both groups studied regarding the degree of patient satisfaction with the anesthetic technique they received. Similar findings were reported in earlier studies reporting on the use of spinal anesthesia for LC.12–15,17 Such findings suggest that spinal anesthesia may be offered to patients undergoing DCLC with a high level of patient satisfaction. Similarly, that more than 90% of the patients in the SA-DCLC group described same-day discharge as “excellent” suggests that DCLC may be performed with a high level of patient satisfaction.
Conclusions
DCLC performed under spinal anesthesia is feasible and safe and is associated with less postoperative pain and lower incidence of PONV and therefore a lower incidence of overnight stay compared with that performed with the patient under general anesthesia.
Footnotes
Disclosure Statement
No competing financial interests exist.
