|Year : 2018 | Volume
| Issue : 4 | Page : 252-256
Combined intrarectal lidocaine gel and periprostatic nerve block: A ‘balanced’ anaesthesia for transrectal ultrasound-guided prostate biopsy?
Taiwo Opeyemi Alabi1, Kehinde Habeeb Tijani1, Adekunle Ayokunle Adeyomoye2, Emmanuel Ajibola Jeje1, Charles Chidozie Anunobi3, Moses Adebisi Ogunjimi1, Rufus Wale Ojewola1, Olanrewaju Nurudeen Akanmu4, Abisola Ekundayo Oliyide1, Dubem Ejikeme Orakwe1
1 Department of Surgery, Urology Unit, Lagos University Teaching Hospital/College of Medicine, University of Lagos, Lagos, Nigeria
2 Department of Radiology, Lagos University Teaching Hospital/College of Medicine, University of Lagos, Lagos, Nigeria
3 Department of Anatomic and Molecular Pathology, Lagos University Teaching Hospital/College of Medicine, University of Lagos, Lagos, Nigeria
4 Department of Anaesthesia, Lagos University Teaching Hospital/College of Medicine, University of Lagos, Lagos, Nigeria
|Date of Web Publication||21-Dec-2018|
Dr. Taiwo Opeyemi Alabi
Department of Surgery, Urology Unit, Lagos University Teaching Hospital/College of Medicine, University of Lagos, Lagos
Source of Support: None, Conflict of Interest: None
Background and Aim: Periprostatic nerve block (PNB) which appears to be the gold standard for pain relief during transrectal ultrasound-guided prostate (TrusP) biopsy has been proven to be lacking in providing satisfactory anaesthesia during transrectal ultrasound (Trus) probe insertion into the anorectum necessitating the addition of another technique to produce a ‘balanced’ anaesthesia. The aim of this study was to determine whether combined intrarectal lidocaine gel and periprostatic nerve block (cGPNB) will provide adequate anaesthesia at all stages of TrusP compared with caudal block (CB). Patients and Methods: Data were prospectively collected from patients with indications for TrusP who were randomly assigned to either cGPNB (Group A) or CB (Group B). Comparative analysis of the numerical rating pain score (NRS) between two groups was done after administration of anaesthesia, Trus probe insertion, biopsy needle puncture of the prostate and 1 h after biopsy. Results: There were 56 patients in Group A and 53 in Group B. There was no significant difference in NRS grouping between the two arms of the study after administration of anaesthesia (P = 0.93), biopsy needle puncture of the prostate (P = 0.28) and 1 h after the procedure (P = 0.39). There was no statistically significant difference in the number of patients with no/mild pain between the two arms of the study during probe insertion (P = 0.65). None of the patients in both arms of the study had severe pain. Across Group A and B, 35 (62.5%) versus 40 (75.5%), 20 (35.7%) versus 11 (20.8%) and 1 (1.8%) versus 2 (3.8%) adjudged the procedure as very tolerable, fairly tolerable and intolerable respectively (P = 0.20). All the patients in Group A versus 49 (92.5%) in Group B will choose the same anaesthesia for subsequent biopsies (P = 0.11). Conclusions: cGPNB provides balanced anaesthesia at all stages of TrusP with excellent patient tolerability.
Keywords: Caudal block, intrarectal lidocaine gel, periprostatic nerve block, prostate biopsy, trans-rectal ultrasound scan
|How to cite this article:|
Alabi TO, Tijani KH, Adeyomoye AA, Jeje EA, Anunobi CC, Ogunjimi MA, Ojewola RW, Akanmu ON, Oliyide AE, Orakwe DE. Combined intrarectal lidocaine gel and periprostatic nerve block: A ‘balanced’ anaesthesia for transrectal ultrasound-guided prostate biopsy?. Niger Postgrad Med J 2018;25:252-6
|How to cite this URL:|
Alabi TO, Tijani KH, Adeyomoye AA, Jeje EA, Anunobi CC, Ogunjimi MA, Ojewola RW, Akanmu ON, Oliyide AE, Orakwe DE. Combined intrarectal lidocaine gel and periprostatic nerve block: A ‘balanced’ anaesthesia for transrectal ultrasound-guided prostate biopsy?. Niger Postgrad Med J [serial online] 2018 [cited 2019 Jun 18];25:252-6. Available from: http://www.npmj.org/text.asp?2018/25/4/252/248211
| Introduction|| |
Transrectal ultrasound-guided prostate (TrusP) biopsy is the most commonly used technique for obtaining specimens for histological diagnosis of the prostate cancer. Extended biopsy protocol has been adopted by many urologists following the evidence that sextant protocol fails to adequately sample the prostate., The proportional increase in the pain with the number of biopsy cores underscores the need for adequate anaesthesia. Previous works have assessed for pain during Trus probe insertion, needle puncture of the prostate and shortly after TrusP but not during the administration of anaesthesia.,,
Caudal block (CB), a form of regional anaesthesia appears to be a balanced anaesthesia for TrusP, the main limitation being transient paraparesis experienced by some of the patients which may affect the procedural turnover. Furthermore, the discomfort experienced by the patient during administration of anaesthesia has not been determined by the previous studies.,
The periprostatic block is arguably the most commonly used anaesthesia and appears to be the gold standard for TrusP., Studies have shown that it is effective during needle puncture of the prostate and shortly after the biopsy but not during the Trus probe insertion into the anorectum. On the other hand, intrarectal lidocaine gel (ILG) has been demonstrated to produce pain relief only during Trus probe insertion into the anorectum. While CB has long been known for its excellent anal sphincter relaxation and pain control, there is a paucity of data comparing it with combined ILG and periprostatic nerve block (cGPNB). To the best of our knowledge, no study has compared pain relief achieved by cGPNB with CB at all stages of the procedure. We, therefore, investigated whether cGPNB will provide a balanced anaesthesia during the application of anaesthesia, Trus probe insertion into the anorectum, needle puncture of the prostate and 1 h after biopsy when compared with CB.
| Patients and Methods|| |
This is a prospective randomised study which was conducted from 23rd January 2014 to 23rd January 2015.
The approval for this study was obtained from the Hospital's Health Research and Ethics Committee on 23rd December 2013. The Health Research Committee assigned number was ADM/DCST/HREC/1666. Informed consent was obtained from all patients.
The sample size was calculated using the formula below used for comparing two independent group means.
n – Minimum estimated sample size per group
SD – Standard deviation of the outcome of interest
d – Smallest difference in mean that it would be clinically significant to detect.
At 5% significance and power of 90%, f(α,β) = 10.5.
If d = 2.5 and SD = 3.5 then, the minimum sample size of each group is
N = n (41) +4.1 (10% attrition rate)
N = 45
The consecutively consenting patients who satisfied any of the inclusion criteria of abnormal digital rectal examination, prostate-specific antigen (PSA) >4 ng/ml and abnormal transrectal ultrasound (Trus) scan findings were randomly assigned by the unit nurse to two cohorts based on the anaesthesia to be administered before TrusP. Group A had cGPNB while Group B had CB. Patients with visual/hearing impairment, back pain/paraplegia/paraparesis from any cause and painful anorectal conditions were excluded from the study.
All patients had a 3-day bowel preparation with liquid diet, oral Dulcolax (bisacodyl) and oral ciprofloxacin. All anticoagulants were discontinued before the procedure.
Group A had initial instillation of 20 ml of 2% lidocaine gel into the anorectum, the index finger of the dominant hand of the examiner was used to massage the gel on the prostate and the anal region. About 10 min thereafter, the Trus probe with a needle guide attached was inserted into the anorectum. A 22 gauge, 20 cm long, Echotip, Skinny needle with Chiba tip (cook medical brand) was then inserted through the needle guide. Injection of 5 ml of 2% lidocaine into each of the bibasal (at the junction of the seminal vesicle and the base of the prostate) and the apical region of the prostate was done under ultrasound guidance [Figure 1].
|Figure 1: Oblique view showing the injection of the 2% lidocaine into the right baso-lateral region of the prostate at the junction of the seminal vesicle and the base of the prostate|
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The Trus evaluation of the prostate (usually concluded within 5 min) was done. Biopsy of the prostate was then done under ultrasound guidance after the anaesthesia has fixed.
Group B had 20 ml of 2% lidocaine injected into the sacral canal with 23G hypodermic needle in prone position. The skin and subcutaneous tissue overlying the sacral hiatus was anaesthesised with initial 2 ml of this 20 ml of 2% lidocaine. Laxity of the anal sphincter was used to assess when the anaesthesia takes effect. About 5 min later, Trus probe with needle guide attached was inserted into the anorectum and biopsy of the prostate done under ultrasound guidance after Trus evaluation of the prostate.
A 7.5 Hz Trus probe (Mindray product, DP2200 model) with its attached needle guide was used for all the biopsies. All patients were positioned left lateral during instillation of lidocaine gel, PNB and during TrusP. Bard Biopsy gun with 18G size, 25 cm length and 22 mm penetration depth was used for all the biopsies. The biopsy of all the patients was done by the same set of investigators comprising of urologist, radiologist, anaesthetists and a unit nurse. The pain was assessed using numerical pain rating scale (NRS) after periprostatic infiltration of lidocaine or CB administration, after Trus probe insertion, after each of the ten core needle biopsies (average NRS was then calculated) and 1 h after the procedure. All the pain assessment was done using NRS by the unit nurse who is blinded to the type of anaesthesia.
Patients' subjective assessment of the anaesthesia, incidence of limb weakness in the Group B as well as other complications in both arms were noted by the unit nurse and documented.
The data obtained were analysed using IBM SPSS Statistics for Windows Version 21.0 (Armonk. NY: IBM Corp.). The (NRSc) obtained was regrouped into (1) No pains (NRS = 0), (2) Mild pain (NRS = 0.1–3), (3) Moderate pain (NRS = 3.1–7) and (4) Severe pain (>7). Similarity in patients' age and BMI between the two groups was assessed using Mann–Whitney U-test. The NRS groups between the two arms of the study were assessed using t-test while total PSA, prostate volume and patients' subjective assessment of anaesthesia were analysed using Pearson Chi-Square/continuity correction as appropriate.
| Results|| |
A total of 112 patients were recruited with 56 in each arm of the study, but data from 109 were analysed. Three patients (5.4%) with fused sacral hiatus were excluded from the analysis in Group B. The demographics for the two arms are as depicted in [Table 1]. The distribution of the patients' age (P = 0.32), BMI (0.14), total PSA (0.31) and prostate volume (0.16) was similar across the two groups.
After administration of anaesthesia, 16 (28.6%) versus 19 (35.8%) had no pain, 36 (64.3%) versus 29 (54.7%) had mild pain and 4 (7.1%) versus 5 (9.4%) had moderate pain while none of the patients had severe pain in the Groups A and B, respectively (P = 0.59).
During probe insertion, 22 (39.3%) versus 41 (77.4%) had no pain, 31 (55.4%) versus 11 (20.8%) had mild pain and 3 (5.4%) versus 1 (1.9%) had moderate pain in the Groups A and B respectively. None of the patients across the two groups had severe pain during probe insertion. However, significantly more patients in Group B had no pain at all during probe insertion (22 [39.3%] vs. 41 [77.4%]) (P = 0.01) [Table 2]. There is no statistically significant difference in the number of patients with no/mild pain between the two arms of the study during probe insertion (P = 0.65).
|Table 2: Comparative analysis of numerical rating pain score groups between the combined gel and periprostatic neve block and caudal block|
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The analysis of NRS groups during biopsy needle puncture of the prostate showed that 18 (32.1%) versus 30 (56.6%) had no pain, 29 (51.8%) versus 19 (35.8%) had mild pain and 7 (12.5%) versus 3 (5.7%) had moderate pain while 2 (3.6%) versus 1 (1.9%) had severe pain in the Groups A and B, respectively (P = 0.59). Majority of patients had no/mild pain 1 h after the biopsy with no statistically significant difference in the distribution of NRS groups between the two arms of the study (P = 0.17) [Table 2].
Majority of the patients 35 (62.5%) versus 40 (75.5%) assessed the procedure as being very tolerable, followed by 20 (35.7%) versus 11 (20.8%) who adjudged it as fairly tolerable in Groups A and B, respectively. Only a few (1 [1.8%] vs. 2 [3.8%]) adjudged it as intolerable in Group A and B, respectively. None of them adjudged the procedure as very intolerable. No statistically significant difference in these distributions across the two groups (P = 0.20) [Table 3].
|Table 3: Patient's subjective assessment of the effectiveness of anaesthesia|
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All the patients in Group A versus 49 (92.5%) in Group B were willing to undergo subsequent biopsy with the same anaesthesia (P = 0.11). However, 12 (21.4%) versus 15 (28.3%) in Group A and B respectively would prefer a better anaesthesia (P = 0.41) [Table 3].
| Discussion|| |
Our study assessed for pain during the administration of anaesthesia, a feature which is very rare in the previous studies. The similarity of distribution of the NRS groups across the two arms of our study despite the differences in the route and procedure of administration of anaesthesia showed that the pain during anaesthesia might not be significantly different when needle injection is required to deliver the anaesthetic agent in a non-sedated patient irrespective of the route.
Pain experienced during probe insertion into the anorectum without anaesthesia has been shown by some previous studies to be more than pain experienced during biopsy needle puncture of the prostate. This degree of pain could discourage patients especially those with tight anal sphincter from the subsequent procedure(s). Periprostatic nerve block (PNB) which is the most commonly used anaesthesia has been shown to be lacking in providing satisfactory anaesthesia during Trus probe insertion. There is therefore need to add an agent to the PNB to make it a ‘balanced’ anaesthesia providing satisfactory pain relief at all stages of the procedure. Many agents have been investigated as adjunct to PNB ranging from local myorelaxant, prilocaine-lidocaine cream to sedation.,,,,, Lidocaine gel would be a preferable adjunct because it is cheap, readily available, easy to administer and safe. Placebo group was not introduced in our study because the previous study has shown that prostate biopsy without anaesthesia is associated with considerable pain.
There are conflicting reports on the role of ILG in TrusP. A study reported significantly less pain compared to placebo whereas other reported no significant role in the tolerance of prostate biopsy. The later, used a suboptimal dose of lidocaine as well as assessed for pain once, at the end of the procedure. This practice did not take into cognizance the pain experienced at the various stages of the biopsy of separate pathophysiology. Moreover, there is a tendency towards ‘pain recall bias’. Stirling et al. reported that ILG produces significant pain reduction during probe insertion but not during biopsy needle puncture compared to PNB. This finding is corroborated by our study which revealed that lidocaine gel is associated with significant pain relief during probe insertion as majority 31 (55.4%) of the patients in Group A had mild pain, 22 (39.3%) had no pain at all, 3 (5.4%) had moderate pain and none of the patients had severe pain. CB has long been known for its excellent anal sphincter relaxation. However, there is paucity of data comparing cGPNB with CB.
Our results showed that significantly more patients in the CB arm, 41 (77.4%) compared to 22 (39.3%) in the cGPNB arm had no pain at all (P = 0.01). However, when the patients who had no pain/mild pain were compared between the two arms of the study (53 (94.6) versus 52 (98.1)), there was no significant difference (P = 0.65).
Our results showed that both cGPNB and CB provided satisfactory pain control during biopsy needle puncture of the prostate and 1 h after biopsy with no significant difference in the NRS group between the two arms of the study. This however, is in contrast with the findings of Horinaga et al. which demonstrated the superiority of periprostatic nerve block over CB. However, the low dose of lidocaine (10 ms of 1%) used in their study could have been responsible for this variations.
Patient's subjective assessment revealed that more patients in the cGPNB compared to CB were willing to undergo subsequent biopsies with the same anaesthesia. Similarly, the number of patients who would prefer a ‘better’ form of anaesthesia for subsequent biopsies other than the one administered to them was less in the cGPNB group, although these differences were not statistically significant. The possible reason for this subjective preference for cGPNB might not be unconnected with the transient inability to walk immediately after the procedure experienced by 37.7% of patients in the caudal arm of the study necessitating short observation. This also makes for a possible higher turnover rate for cGPNB since no prolonged observation is required. The procedure-related complication was compared between the two arms of the study, and it showed no statistically significant difference between the two arms of the study.
This study demonstrates the effectiveness of cGPNB in pain control during Trus probe insertion into the anorectum, Chiba needle puncture of the prostate capsule for the administration of anaesthesia, Tru-Cut biopsy needle puncture of the prostate and 1 h after biopsy. It also showed the superiority of cGPNB in terms of patients' subjective assessment of preference with no significant infective complication rate despite the theoretical risk of inoculation of infection during Chiba needle puncture of the prostate capsule for the administration of anaesthesia.
| Conclusions|| |
We concluded that cGPNB is a ‘balanced anaesthesia’ for TrusP in that it offered effective pain control at all stages of TrusP with higher patients' preference as the anaesthesia of choice for subsequent biopsies. It also has no significantly different infective or other biopsy/anaesthesia-related complications when compared with CB.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patient understands that name and initials will not be published and due efforts were made to conceal identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Eskew LA, Bare RL, McCullough DL. Systematic 5 region prostate biopsy is superior to sextant method for diagnosing carcinoma of the prostate. J Urol 1997;157:199-202.
Gore JL, Shariat SF, Miles BJ, Kadmon D, Jiang N, Wheeler TM, et al.
Optimal combinations of systematic sextant and laterally directed biopsies for the detection of prostate cancer. J Urol 2001;165:1554-9.
Leibovici D, Zisman A, Siegel YI, Sella A, Kleinmann J, Lindner A. Local anesthesia for prostate biopsy by periprostatic lidocaine injection: A double-blind placebo controlled study. J Urol 2002;167:563-5.
Kravchick S, Peled R, Ben-Dor D, Dorfman D, Kesari D, Cytron S. Comparison of different local anesthesia techniques during TRUS-guided biopsies: A prospective pilot study. Urology 2005;65:109-13.
Ooi WL, Hawks C, Tan AH, Hayne D. A randomised controlled trial comparing use of lignocaine periprostatic nerve block alone and combined with diclofenac suppository for patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy. BJU Int 2014;114 Suppl 1:45-9.
Yun TJ, Lee HJ, Kim SH, Lee SE, Cho JY, Seong CK. Does the intrarectal instillation of lidocaine gel before periprostatic neurovascular bundle block during transrectal ultrasound guided prostate biopsies improve analgesic efficacy? A prospective, randomized trial. J Urol 2007;178:103-6.
Ikuerowo SO, Popoola AA, Olapade-Olaopa EO, Okeke LI, Shittu OB, Adebayo SA, et al.
Caudal block anesthesia for transrectal prostate biopsy. Int Urol Nephrol 2010;42:19-22.
Cesur M, Yapanoglu T, Erdem AF, Ozbey I, Alici HA, Aksoy Y. Caudal analgesia for prostate biopsy. Acta Anaesthesiol Scand 2010;54:557-61.
Tiong HY, Liew LC, Samuel M, Consigliere D, Esuvaranathan K. A meta-analysis of local anesthesia for transrectal ultrasound-guided biopsy of the prostate. Prostate Cancer Prostatic Dis 2007;10:127-36.
Autorino R, De Sio M, Di Lorenzo G, Damiano R, Perdonà S, Cindolo L, et al.
How to decrease pain during transrectal ultrasound guided prostate biopsy: A look at the literature. J Urol 2005;174:2091-7.
Alavi AS, Soloway MS, Vaidya A, Lynne CM, Gheiler EL. Local anesthesia for ultrasound guided prostate biopsy: A prospective randomized trial comparing 2 methods. J Urol 2001;166:1343-5.
Stirling BN, Shockley KF, Carothers GG, Maatman TJ. Comparison of local anesthesia techniques during transrectal ultrasound-guided biopsies. Urology 2002;60:89-92.
Luscombe CJ, Cooke PW. Pain during prostate biopsy. Lancet 2004;363:1840-1.
Kumar A, Griwan MS, Singh SK, Sen J, Pawar DS. Is periprostatic nerve block a gold standard in case of transrectal ultrasound-guided prostate biopsy? Urol Ann 2013;5:152-6.
] [Full text]
Jindal T, Mandal SN, Biswas G, Karmakar D. Evaluation of the efficacy of a combination of diltiazem and periprostatic nerve block in pain control during transrectal ultrasonography-guided biopsy of the prostate. Ann R Coll Surg Engl 2013;95:361-4.
Doğanca T, Savsin A, Erdoğan S, Altindas F, Özdemir F, Ekici B, et al.
Procedural sedation and analgesia as an adjunct to periprostatic nerve block for prostate biopsy: A prospective randomized trial. J Clin Ultrasound 2015;43:288-94.
Noh DH, Cho MC, Park HK, Lee HW, Lee KS. The effects of combination perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided biopsy of the prostate: A randomized, controlled trial. Korean J Urol 2010;51:463-6.
Cantiello F, Imperatore V, Iannuzzo M, Scibelli G, Di Meo S, Fusco F, et al.
Periprostatic nerve block (PNB) alone vs. PNB combined with an anaesthetic-myorelaxant agent cream for prostate biopsy: A prospective, randomized double-arm study. BJU Int 2009;103:1195-8.
Zisman A, Leibovici D, Kleinmann J, Siegel YI, Lindner A. The impact of prostate biopsy on patient well-being: A prospective study of pain, anxiety and erectile dysfunction. J Urol 2001;165:445-54.
Saad F, Sabbagh R, McCormack M, Péloquin F. A prospective randomized trial comparing lidocaine and lubricating gel on pain level in patients undergoing transrectal ultrasound prostate biopsy. Can J Urol 2002;9:1592-4.
Desgrandchamps F, Meria P, Irani J, Desgrippes A, Teillac P, Le Duc A, et al.
The rectal administration of lidocaine gel and tolerance of transrectal ultrasonography-guided biopsy of the prostate: A prospective randomized placebo-controlled study. BJU Int 1999;83:1007-9.
Horinaga M, Nakashima J, Nakanoma T. Efficacy compared between caudal block and periprostatic local anesthesia for transrectal ultrasound-guided prostate needle biopsy. Urology 2006;68:348-51.
[Table 1], [Table 2], [Table 3]