Selective Low-Dose Spinal Anesthesia for Transrectal Prostate Biopsy: A Prospective and Randomized Study

Abstract

Purpose:

To evaluate the use of spinal anesthesia by reducing anesthetic agent dose to provide better analgesia with minimal side effects without sacrificing the outpatient setting for prostate biopsy. In this study, efficacy and tolerability of selective low-dose spinal anesthesia versus intrarectal local anesthesia (IRLA) plus periprostatic nerve blockade (PPNB) were compared.

Methods:

Between September 2012 and April 2013, 100 patients, aged 40 to 80 years, prostate-specific antigen (PSA) ≥4 ng/mL, abnormal digital rectal examinations, and enrolled for biopsy were included in the present study. Ensuring double blindness, pain was assessed using the visual analog scale (VAS). Anal sphincter relaxation, patient satisfaction with the anesthesia technique, and motor response were evaluated.

Results:

Differences between the two groups, considering age, American Society of Anesthesiologist score, total PSA, prostate volume, anesthesia duration, and cancer presence, were not statistically significant. Pain experienced during probe insertion, biopsy, and 30 minutes after biopsy was significantly lower in the low-dose spinal anesthesia group (P < 0.0001). Anal sphincter relaxation degree was significantly higher in the spinal group (P < 0.001). Patient procedure-related overall satisfaction level was significantly higher in the spinal anesthesia group (P < 0.001). In the spinal anesthesia group, no motor blockade was observed. Between the two groups, no statistically significant difference was seen with regard to complications (P > 0.05).

Conclusion:

Introduction

Prostate cancer is the most common cancer type in men with high mortality subsequent to lung cancer. The common use of prostate-specific antigen (PSA) level as a serum marker and of imaging techniques such as transrectal ultrasonography (TRUS) now enables diagnosis at early stages. Whereas the 5-year survival rate is 100% in localized prostate cancer, it decreases to 29% with metastasis, indicating the importance of early definitive diagnosis.¹

TRUS-guided prostate biopsy is the standard procedure in the diagnosis of prostate cancer. The first systematic biopsy scheme, the “sextant” biopsy, described first by Hodge and assocites,² was used as the gold standard for several years. Various biopsy schemes were described in the literature after the late 1990s, however, when the sextant biopsy scheme was proven for its inefficacy in diagnosing cancer in different regions of the prostate.^3
–5 There is still not a consensus about an appropriate biopsy scheme; yet, a common understanding of the necessity for at least 10 to 14 core biopsy samples prevails.⁵

Biopsy was considered as a painless procedure with tolerable discomfort in the early years. Recent studies report moderate to severe pain and discomfort in about 65% to 90% of the patients during prostate biopsy, especially during probe insertion into the anal canal, probe motions, and taking core biopsies.^6,7 The pain experienced can not only prevent taking of sufficient cores from various regions of the prostate, it may also hinder a repeated biopsy even if necessary because the patients experiencing the pain may not give their consent.^8,9 This makes effective pain management before prostate biopsy mandatory. Biopsy without anesthesia is considered even as malpractice.¹⁰

To make biopsy more tolerable, indicating the necessity of anesthesia and the lack of a consensus, intrarectal local anesthesia (IRLA), lidocaine suppositories, intraprostatic local anesthesia (IPLA), periprostatic nerve blockade (PPNB), pudendal nerve blockade (PNB), pelvis plexus block (PPB), caudal block, nonsteroidal anti-inflammatory drugs, tramadol, intravenous sedation with propofol, midazolam, nitrogen oxide have been applied.¹¹ While providing adequate analgesia with minimal side effect, appropriate anesthesia should not sacrifice the outpatient setting for prostate biopsy.

Spinal anesthesia, necessitating hospitalization, is widely used in prostate, bladder, and anal interventions. It is not used, however, for prostate biopsy routinely in a day case setting. We hypothesized that reducing the dose of anesthetic agent used in spinal anesthesia would minimize the side effects, thus not sacrifice the outpatient setting and achieve better analgesia. In this prospective randomized study, efficacy and tolerability of selective low-dose spinal anesthesia versus IRLA plus PPNB were compared in an outpatient setting.

Methods

The present prospective, randomized, and double-blind study has been conducted following the approval of the Ethical Review Board at Selçuk University Faculty of Medicine between September 2012 and April 2013. Patients, aged between 40 and 80 years, with a PSA level ≥4 ng/mL, and/or abnormal digital rectal examinations (DREs), who were scheduled for TRUS-guided prostate biopsy, were included in the present study. After obtaining their written consent, a total of 100 patients matching the inclusion criteria, who were informed about complications of TRUS-guided prostate biopsy, anesthesia methods, and clinical trial, were randomized 1:1 by sealed envelope technique by which the investigator and the patients were blinded.

Group 1 received IRLA plus PPNB and group 2 received selective low-dose spinal anesthesia. Patients with a medical history of prostate biopsy, bleeding diathesis, or use of anticoagulants, painful conditions of the anal region such as hemorrhoids and anal fissure, chronic pelvic pain syndrome or chronic prostatitis, neurologic conditions diminishing pain sensation, using analgesics or narcotics, mental dysfunction or inability to give accurate responses to questions, with known lidocaine or bupivacaine allergy were excluded. In total, 108 patients were assessed, and 8 of them were not meeting the inclusion criteria.

Age, medical history, American Society of Anesthesiologists (ASA) score, total and free PSA level, prostate volume, DRE findings of all patients were recorded. Antibiotic prophylaxis was initiated 1 day before biopsy and continued for 4 subsequent days using 500 mg ciprofloxacin, twice a day, orally. Toshiba SSA-530A model ultrasound scanner and 6 MHz rectal probe were used for imaging. Prostate volume was measured before biopsy using an ellipsoid formula. All biopsies were performed with the patient in the left lateral decubitus position with an automatic biopsy gun and an 18-gauge Tru-cut needle by the same urologist including base, midzone, and apex bilaterally based on a 14-core biopsy scheme.

Anesthesia procedure for group 1 (IRLA + PPNB)

Initially, to ensure the blindness of the patient to the anesthesia method preferred, the urologist touched and pressed the patient's back with the back of an injection needle with the patient in sitting position and told the patient that anesthesia was applied. With the patient in the left lateral decubitus position, 10 cc of 2% lidocaine gel was applied around the anal ring and into the rectum, 5 minutes before placing the TRUS probe. Subsequently, PPNB, 2.5 mL of 2% lidocaine were injected by the same urologist on each side (total 5 mL) into the neurovascular bundles at the prostate-bladder-seminal vesicle angle in the sagittal plane using a 20-cm 18-gauge spinal needle. We ensured that the lidocaine was deposited in the correct plane between prostate and rectum by TRUS guidance. Care was taken to avoid intraprostatic and intravenous injection. Five minutes after PPNB, prostate biopsies were performed.

Anesthesia procedure for group 2 (selective low-dose spinal anesthesia)

All the patients underwent low-dose spinal anesthesia by the same anesthetist injecting 0.3 mL, 0.5% hyperbaric bupivacaine (equivalent to 1.5 mg bupivacaine) into the spinal subarachnoid space between L4/L5 vertebrae using a 27-gauge pencil point needle with the patient in the sitting position. Patients remained in the sitting position for 5 minutes after the injection to enable anal region bupivacaine block. Subsequently, 10 cc ultrasound gel was applied into the rectum to facilitate probe movements before a standard 14-core biopsy was performed. After the procedure, all patients were hospitalized for 1 hour in our 1-day surgery center and assessed for immediate complications. After successful voiding, all were discharged to home.

Pain was assessed by a separate blinded observer using the visual analog scale (VAS) in which 0 represents no pain and 10 represents the worst pain ever felt. VAS pain scores were recorded at certain time points including: VAS 1 (during anesthesia), VAS 2 (introduction and movements of the probe), VAS 3 (during needle biopsy), VAS 4 (30 min after biopsy). VAS 1, 2, and 3 pain scores were obtained immediately after biopsy and VAS 4 30 minutes later. Anal sphincter relaxation was evaluated before the biopsy as not relaxed, relaxed, or very relaxed by a blinded urologist.

Patient satisfaction with the anesthesia technique was evaluated with a four-point Likert scale (0 = not satisfied, 1 = somewhat satisfied, 2 = satisfied, 3 = very satisfied) by asking the question, “Are you satisfied with the current anesthesia method for prostate biopsy?” and afterward, “If you need a repeated biopsy later, would you like to have the same anesthesia method?” to evaluate their willingness for a repeated biopsy. Their answers were recorded as “yes” or “no.”

Anesthesia duration (min) was measured from the induction of anesthesia to the beginning of the needle biopsy by a nurse using a chronometer. Likewise, biopsy duration was measured from the beginning of the first needle biopsy until the removal of the TRUS probe. Total procedure time was obtained by calculating the total of these two values. Blood pressure and heart rate of all patients were measured before anesthesia and after biopsy completion. Motor response was evaluated by a blinded observer using a modified Bromage scale (0 = full movement, 1 = movement of knees only, 2 = movement of ankles only, 3 = no movement) immediately after the biopsy in the operating room. Finally, we recorded the time point patients were able to walk without help after biopsy.

Complications were graded as severe (hypotension and/or syncope necessitating intravenous therapy, allergic reactions, hematuria and/or rectal bleeding necessitating hospitalization, acute urinary retention, urosepsis, acute prostatitis with fever greater than 38.5°C), and mild (self-limiting hematuria and/or rectal bleeding, hematospermia, urinary tract infection without fever, postdural puncture headache, low back pain). Complications were recorded by a blinded observer immediately after the procedure in our 1-day surgery center, the fifth day after biopsy via telephone interview, and at 1 month follow-up in the outpatient clinic for delayed complications when the patients returned for pathology results.

Statistical analyses were performed using the SPSS 18 statistical package (SPSS, Inc., Chicago, IL). The differences in VAS pain scores, PSA level, and prostate volume between the two groups were analyzed using Mann Whitney U test. Age and duration of procedure were compared with the Student t test. Differences in ASA scores, anal sphincter relaxation degree, DRE findings, pathology results, overall satisfaction, willingness to have a repeated biopsy, and complications were analyzed using the chi-square test. Data were presented as median (range), mean (standard deviation), or frequencies as appropriate. P value < 0.05 was considered statistically significant.

Results

The participants of the study were divided equally into two cohorts consisting of 50 patients each. Considering age, ASA score, total PSA level, prostate volume, number of biopsies made, abnormal DRE findings, duration of anesthesia, and biopsy, differences between the two groups were not statistically significant (Table 1). The total procedure lasted in the first group 14.8 ± 2.4 minutes and in the second, 15 ± 2.6 minutes (P = 0.606). In group 1, cancer was present in 17 (34%) and in group 2, 15 (30%). No statistically significant difference was determined related to cancer presence in both groups (P = 0.830).

Table 1.

Patient Characteristics, Anesthesia Duration, and Biopsy

	IRLA + PPNB	Spinal anesthesia	P value
Patients (n)	50	50
Age (years)	64.4 ± 7.6	63.7 ± 8.1	0.678
ASA (1/2/3)	2/40/8	4/39/7	0.684
tPSA (ng/mL)	18.2 ± 23.2	18.2 ± 23.6	0.771
Prostate volume (cm³)	68.9 ± 31.3	75.26 ± 41.2	0.406
Abnormal DRE (n[%])	17 (34%)	12 (24%)	0.378
Number of cores (n)	14	14
Duration of anesthesia (min)	9.8 ± 1.9	10 ± 2.3	0.532
Duration of biopsy (min)	5.0 ± 0.9	5 ± 1.1	0.999
Total duration (min)	14.8 ± 2.4	15 ± 2.6	0.606

Values are mean ± standard deviation or numbers (percentages).

IRLA = intrarectal local anesthesia; PPNB = periprostatic nerve blockade; ASA = American Society of Anesthesiologists; tPSA = total prostate-specific antigen; DRE = digital rectal examination.

There was no statistically significant difference in pain scores during IRLA + PPNB and selective low-dose spinal anesthesia application (P = 0.239). Pain experienced during probe insertion, biopsy, and 30 minutes after biopsy was significantly lower in the selective low-dose spinal anesthesia group (P < 0.0001). Table 2 reveals VAS pain scores reported by the patients before, during, and after biopsy. Anal sphincter relaxation degree was significantly higher in the spinal group (P < 0.001). In PPNB + IRLA group, 13 (26%) patients had a nonrelaxed sphincter and 37 (74%) patients had a relaxed sphincter. The number of patients with nonrelaxed, relaxed, and very relaxed sphincter in the spinal group was 1 (2%), 21 (42%), and 28 (56%), respectively.

Table 2.

Visual Analog Scale Pain Scores

	IRLA + PPNB Mean ± SD	Spinal anesthesia Mean ± SD	P value
VAS 1 (during anesthesia)	1.86 ± 1.37	1.60 ± 1.06	0.239
VAS 2 (probe insertion)	3.20 ± 2.14	0.24 ± 0.43	<0.0001
VAS 3 (biopsy)	3.28 ± 1.91	0.28 ± 0.60	<0.0001
VAS 4 (30 min after biopsy)	1.80 ± 1.24	0.44 ± 0.86	<0.0001

SD = standard deviation; VAS = visual analog scale.

The overall satisfaction level of the patients related to the procedure was significantly higher in the spinal anesthesia group (P < 0.001). If prostate biopsy would be needed in future, 30 (60%) patients in group 1 and 48 (96%) patients in group 2 would be willing to accept repeated biopsy using the same anesthesia method (P < 0.001). Table 3 shows patient satisfaction and willingness for repeated biopsy.

Table 3.

Patient Satisfaction and Willingness for Repeated Biopsy

	IRLA + PPNB (n = 50)	Spinal anesthesia (n = 50)	P value
Not satisfied	3 (6%)	0 (0%)	<0.001
Somewhat satisfied	15 (30%)	1 (2%)	<0.001
Satisfied	25 (50%)	4 (8%)	0.001
Very satisfied	7 (14%)	45 (90%)	<0.001
Willingness to have a repeated biopsy	30 (60%)	48 (96%)	<0.001

None of the patients experienced motor blockade, and the modified Bromage score was 0 for all in the spinal anesthesia group. All patients were able to walk without assistance immediately after the biopsy. The number of patients with a 20% change in blood pressure compared with the preoperative value was 4 (8%) in group 1 and 7 (14%) in group 2. The number of patients with a change in heart rate more than 10% compared with the preoperative value was 13 (26%) in group 1 and 14 (28%) in group 2. Considering blood pressure and heart rate alterations, there was no statistically significant difference (P > 0.05). None of the patients in both groups had clinically significant hypotension or bradycardia.

Acute prostatitis was the only severe complication that emerged in three patients of group 1 and two of Group 2 (P = 1). A urethral catheter was inserted into a patient in group 1 with benign prostatic hyperplasia because of acute urinary retention. There was no statistically significant difference between the two groups with respect to complications (P > 0.05). None of the patients had spinal headache and low back pain.

Discussion

TRUS-guided prostate biopsy is one of the most common office procedures performed by urologists. Prostate biopsy is experienced under considerable psychological stress because of potential cancer diagnosis, anal penetration to the organ that is a part of sexuality with a probe, and pain, discomfort anticipated during probe insertion and core biopsies.¹¹ Performing this highly stressful intervention without any kind of anesthesia is considered as malpractice. Several anesthesia techniques have been investigated, but the perfect method has not been defined yet.

PPNB plus IRLA is the most popular and widely used anesthesia method for prostate biopsy. PPNB with or without IRLA does not yield satisfactory analgesic effect, however. Thus, this is still being investigated to propose different anesthesia methods by adding different modalities to PPNB including IRLA, IPLA, oral paracetamol, and codeine.^12
–14 Various infiltration sites have been described for PPNB including only the apex, bilateral neurovascular bundle regions, apex and neurovascular bundle, three locations (mid, apex, base) posterior-laterally, and lateral to the tip of the seminal vesicles.¹⁰

The revision of studies comparing the efficacy and tolerability of PPNB with other anesthesia methods revealed higher mean VAS scores for PPNB groups comparing a novel method with PPNB^15
–17 than studies comparing PPNB with placebo or IRLA.^13,18
–20 These results are confusing and indicate the presence of a possible bias in the studies. On the other hand, several studies have shown that PPNB with or without IRLA does not relieve pain completely during prostate biopsy.^{12,15
–17,21
–23} VAS pain scores during prostate sampling reported in various studies are presented in Table 4.

Table 4.

Pain Scores in Various Periprostatic Nerve Blockade Studies

Study	Method	Pain scores, respectively	P value
Lee et al¹⁷	PPNB vs IPLA vs IPLA + PPNB	4.5 ± 2.6 vs 4.3 ± 2.7 vs 2.7 ± 2.1	0.032
Yun et al²¹	PPNB vs IRLA + PPNB	3.9 ± 2.05 vs 2.9 ± 2.3	<0.01
Cantiello et al¹⁶	IRLA + PPB vs IRLA + PPNB	2.28 ± 0.84 vs 3.37 ± 0.78	<0.001
Akpinar et al¹⁵	PPB vs PPNB	2.7 ± 1.95 vs 4.97 ± 2.16	<0.0001
Bingqian et al¹²	PPNB + IPLA vs PPNB	2.89 ± 1.09 vs 3.56 ± 1.09	<0.0001
Singh et al²³	PPNB + IPLA vs PPNB	2.70 ± 0.86 vs 3.39 ± 0.91	0.000
Song et al²²	PPNB vs IRLA	3.6 ± 2.1 vs 5.5 ± 2.7	<0.0001

IPLA = intraprostatic local anesthesia; PPB = pelvis plexus block.

In line with these, the mean VAS pain score during biopsy was 3.28 ± 1.91, and 19 (38%) patients' pain score was higher than 3 patients in PPNB plus IRLA group in the present study. There was a high statistically significant difference in the number of patients who had a pain score of 4 or more. Whereas 19 (38%) patients in the PPNB plus IRLA group had ≥4 pain score, there were none in the spinal anesthesia group. Actually, a significant number of patients felt moderate to severe pain despite PPNB plus IRLA application.

Our pain score results are very similar to the prospective, double-blind, randomized trial of Cantiello and colleagues,¹⁶ who compared PPNB plus IRLA versus PPB plus IRLA and reported 3.37 ± 0.78 versus 2.28 ± 0.84 pain scores, respectively. The studies by Cantiello and colleaues¹⁶ and Akpinar and coworkers¹⁵ concluded that PPB provides better anesthesia than PPNB because the local anesthetic agent is applied more proximal to the nerves that innervate the prostate and affects all sensory fibers of the prostatic plexus. Because nerve blockade was made on the most proximal possible region in selective low-dose spinal anesthesia, lack of pain is expected.

Spinal anesthesia has been known to be an ideal anesthesia for anorectal surgery. There is ≥0.8 mL bupivacaine administered for routine perianal surgeries, however, causing motor block of the lower extremities, changes in systemic blood pressure, and heart rate.²⁴ Therefore, spinal anesthesia has not been used as a day case procedure such as prostate biopsy. Currently, Wassef and associates²⁵ reduced the dose of bupivacaine to 1.5 mg and achieved successful anesthesia without motor blockade of lower limbs in short perianal surgeries. Obi and coworkers²⁶ compared PPNB with spinal anesthesia by using 0.5 mL 0.5% bupivacaine (equivalent to 2.5 mg) and reported VAS pain scores of 4.6 ± 2.3 and 0.7 ± 1.6 respectively. They concluded that spinal anesthesia achieved better analgesia than PPNB without sacrificing the outpatient setting.²⁶

So far, spinal anesthesia was compared with general anesthesia with propofol for prostate biopsy. Nishikawa and colleagues²⁷ and Sundarathiti and associates²⁸ found both anesthesia techniques achieved acceptable analgesia, but spinal anesthesia was more preferable than propofol with respect to costs and safety.

In the present study, we used 0.3 mL 0.5% bupivacaine (1.5 mg) and evaluated pain during anesthesia, probe insertion, prostate sampling, and 30 minutes after biopsy. In the present study, VAS pain scores were significantly lower in the selective low-dose spinal anesthesia group than the PPNB group: 0.24 ± 0.43 (probe insertion), 0.28 ± 0.60 (biopsy), and 0.44 ± 0.86 (30 minutes after biopsy). All patients in spinal anesthesia group were able to walk without aid immediately after the biopsy and voided successfully within an hour. None of the patients had significant blood pressure and heart rate changes. Considering the mean duration of the procedure, there was not a statistically significant difference between the two groups. Hence, selective low-dose spinal anesthesia can be reported as not the cause of any additional time.

Cancer is detected in approximately 25% of patients undergoing initial prostate biopsy; thus, a significant number of patients will often need a repeated biopsy.⁸ The willingness to accept a repeated biopsy is associated with the amount of pain and discomfort perceived at the initial biopsy. In several studies, the proportion of patients willing to have a repeated biopsy was higher in the anesthesia groups than in the control.^26,29 In our study, patients in the spinal anesthesia group were significantly more satisfied. Thus, the number of the patients willing to accept a repeated biopsy with the same anesthesia method was 48 (96%) and 30 (60%) in the spinal and PPNB groups, respectively. Similarly, Obi and coworkers²⁶ reported that 88% of the patients in the spinal anesthesia group were willing to have a repeated biopsy versus 72% in the PPNB group. The difference was not statistically significant, however.

Muscle relaxation of the anal sphincter also makes the DRE of the prostate and insertion and maneuvering of the probe easier and reduces probe insertion pain. As an additional advantage, selective low-dose spinal anesthesia results in perianal analgesia and anal sphincter relaxation. The advantages of selective low-dose spinal anesthesia are high patient satisfaction, significantly lower pain scores in all stages of the procedure, willingness for a repeated biopsy, significantly more relaxed anal sphincter, stable systemic blood pressure and heart rate, PPNB similar mean procedure time, no statistically significant difference in complications.

The possible disadvantages of selective low-dose spinal anesthesia are the need of an anesthetist and related additional cost (anesthetist fee), spinal headache or backache, systemic blood pressure or heart rate changes, risk of infection into the subarachnoid space. The incidence of spinal headache, however, is 2% to 8% but decreases with advancing age and should not be a major concern in patients undergoing prostate biopsy.³⁰ None of the patients had spinal headache or backache in the present study using only 1.5 mg bupivacaine and thus preventing hemodynamic instability or motor paralysis. Infection from dural puncture is a very rare condition and does not occur if the necessary aseptic precautions are taken.

On the other hand, in some countries, prostate biopsies are conducted in the physician's offices. Therefore, in some cases, spinal anesthesia is impractical because there are no anesthetists at hand. If prostate biopsies are performed in a hospital rather the physician's office, this may lead to additional cost because of hospitalization and logistics. In many countries, however, prostate biopsies are performed in hospitals or surgery centers. To our knowledge, these drawbacks should be considered with the obvious advantage of obtaining perfect analgesia without hemodynamic instability and motor paralysis.

One of the limitations of this study is related to blinding. We touched and pressed the patient's back with the back of an injection needle for the sham spinal, not an exact spinal injection of physiologic serum for ethical reasons and for comparing the pain during anesthesia application. Some may have discovered which group they were allocated to and thus undermined blinding. Another limitation is the lack of a placebo or control group because TRUS-guided biopsy without any form of anesthesia is considered malpractice. The sample size of the study is not enough to investigate prostate biopsy complications. Thus, the study is underpowered concerning complications.

Conclusion

Selective low-dose spinal anesthesia provides better pain relief than PPNB plus IRLA without sacrificing the day case setting in ambulatory practice. It is also associated with high patient satisfaction and willingness for a repeated biopsy without differences in procedure duration, tolerance, and complications. The only drawback is the need for an anesthetist and related additional cost (anesthetist fee). Selective low-dose spinal anesthesia should be applied in men undergoing TRUS-guided prostate biopsy.

Footnotes

Author Disclosure Statement

None of the authors have conflicting interests.

Abbreviations Used

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