Pudendal Nerve Block vs Penile Nerve Block for Analgesia During Pediatric Circumcision

Regional Anesthesia Clinical Trial

Official title:

Randomized Controlled Trial Comparing Ultrasound-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block for Analgesia Following Pediatric Circumcision

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03914365
• Other study ID #: 2018-4132
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pediatric circumcision has been realized since the beginning of human civilization. In the United States, a 2014 review revealed a 81% prevalence of men 14-59 years old being circumcised. Circumcision surgery is mostly performed on an ambulatory basis. The best analgesia technique for this procedure has yet to be determined. Local, regional, general anaesthesia or even combinations have been described. The Dorsal Penile Nerve Block (DPNB) has been shown to be superior to topical analgesia in neonatal circumcision. A 2008 Cochrane review showed no difference in pain scores between caudal block and DPNB, but described more motor block with caudal block. For this reason, the 2017 Canadian Urological Association guidelines review recommends using DPNB with a ring block as a standard of care for neonatal circumcision with-out general anaesthesia. However, DPNB does not provide reliable coverage of the ventral surface of the penis and frenulum. Pudendal nerve block (PNB) is another regional anaesthesia technique gaining in popularity with the now widespread use of ultrasound guidance. However, it is still unclear if PNB can give better outcomes than DPNB. The ultrasound-guided pudendal nerve block has only been recently described and was not reviewed as an option at the time of the guidelines writing. PNB can be performed using surface landmarks, with nerve stimulation or with ultra-sound-guidance. It has already been proven to have lower surgical complication rates than caudal block for hypospadias surgeries. Regarding DPNB, a variety of techniques have been described using either surface landmarks or ultrasound guidance. In the past ten years, two RCTs in Lebanon and Turkey compared PNB and DPNB for penile surgeries, showing lower pain scores and lower narcotics consumption in the pudendal nerve block group. None of these studies used ultrasound-guidance. The investigators perform more than a hundred pediatric circumcisions yearly for medical indications. The surgery is done under general anaesthesia in association with either PNB or DPNB, depending on the anesthesiologist's preference. The primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain. The research team will compare peri and postoperative pain in children receiving either ultrasound-guided pudendal nerve block or ultrasound-guided dorsal penile nerve block for circumcision surgery.

Description:

All patients will receive inhalational anaesthesia induction with a mixture of oxygen/nitrous oxide and 6% sevoflurane. Nitrous oxide will be discontinued after loss of consciousness. Standard monitoring will be applied including electrocardiography, pulse oxymetry, capnography and non-invasive blood pressure monitoring. After establishing intravenous access, anaesthesia will be deepened using propofol 1 to 3 mg/kg and fentanyl 1 mcg/kg before laryngeal mask airway insertion or intubation. Neuromuscular blockade will not be administered. Maintenance of anaesthesia will be provided with sevoflurane with an end tidal sevoflurane between 1 and 1,5 MAC. Five regional anesthesia experienced anesthesiologists not involved in the subsequent intraoperative or postoperative care of the patient will perform blocks. Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed and sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile technique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle positioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropivacaine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side. Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space. The heart rate and blood pressure will be recorded before the block and every 5 minutes after block completion by the anaesthesiologist unaware of block assignment involved in the intraoperative and postoperative care of the patient. Surgical incision will be delayed for a minimum of 15 minutes after block completion. Three surgeons will perform all circumcisions using the same surgical technique. Any in-crease in blood pressure or heart rate of more than 20% above baseline within 20 minutes of block completion will be treated with an additional propofol bolus (1mg/kg) or by increasing end-tidal sevoflurane to allow for onset of the block. Any increase in blood pressure or heart rate of more than 20% above baseline 20 minutes or more after the block will be considered inadequate analgesia and will be supplemented with fentanyl 1 mcg/kg. All patients will receive dexamethasone 0,1 mg/kg (max 8 mg) and ondansetron 0,1 mg/kg (max 4 mg). Ketorolac 0,5 mg/kg (max 30 mg) will also be administered at the end of the surgery. Pain scores using the FLACC score(16) will be recorded in the post-anesthesia care unit (PACU) and ambulatory step down unit at 5, 30, 60 and 120 minutes postoperatively by trained and blinded nurses. A pain score of 4 or higher in the PACU will lead to analgesic administration. A first dose of nalbuphine 0,1 mg/kg will be administered. If inadequate, incremental doses of morphine 0,05 mg/kg will be given until adequate analgesia is achieved. Pain will also be evaluated by parents at home using the parent postoperative pain measure (PPPM) scale at 6, 12 and 24 hours postoperatively. The parents will be instructed by a trained nurse on how to assess the child's pain using this pain measure. Patients will be prescribed acetaminophen 15 mg/kg q 4h regularly (maximum 5 doses/24 hours), ibuprofen 10 mg/kg q 8h regularly and morphine 0,1 mg/kg q 4h as needed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• Male 1-12 yo undergoing elective circumcision for medical reasons

Exclusion Criteria:

• Allergy to local anaesthetics or medication used in the study Coagulopathy Infection at the injection site Neurologic or neuromuscular disease ASA classification = 4

Related Conditions & MeSH terms

• Male Circumcision
• Regional Anesthesia

Intervention

Procedure:
• Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)
Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.

Locations

Country	Name	City	State
Canada	CHU de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

References & Publications (20)

Berde CB, Walco GA, Krane EJ, Anand KJ, Aranda JV, Craig KD, Dampier CD, Finkel JC, Grabois M, Johnston C, Lantos J, Lebel A, Maxwell LG, McGrath P, Oberlander TF, Schanberg LE, Stevens B, Taddio A, von Baeyer CL, Yaster M, Zempsky WT. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop. Pediatrics. 2012 Feb;129(2):354-64. doi: 10.1542/peds.2010-3591. Epub 2012 Jan 16. — View Citation

Boric K, Jelicic Kadic A, Boric M, Zarandi-Nowroozi M, Jakus D, Cavar M, Dosenovic S, Jeric M, Batinic M, Vukovic I, Puljak L. Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents. Eur J Pain. 2019 Feb;23(2):389-396. doi: 10.1002/ejp.1313. Epub 2018 Sep 21. — View Citation

Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004217. Review. — View Citation

Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. — View Citation

Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD003005. doi: 10.1002/14651858.CD003005.pub2. Review. — View Citation

Dave S, Afshar K, Braga LH, Anderson P. Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version). Can Urol Assoc J. 2018 Feb;12(2):E76-E99. doi: 10.5489/cuaj.5033. Epub 2017 Dec 1. — View Citation

Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5. — View Citation

Hecht S, Piñeda J, Bayne A. Ultrasound-guided Pudendal Block Is a Viable Alternative to Caudal Block for Hypospadias Surgery: A Single-Surgeon Pilot Study. Urology. 2018 Mar;113:192-196. doi: 10.1016/j.urology.2017.11.006. Epub 2017 Nov 16. — View Citation

Howard CR, Howard FM, Fortune K, Generelli P, Zolnoun D, tenHoopen C, deBlieck E. A randomized, controlled trial of a eutectic mixture of local anesthetic cream (lidocaine and prilocaine) versus penile nerve block for pain relief during circumcision. Am J Obstet Gynecol. 1999 Dec;181(6):1506-11. — View Citation

Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447. — View Citation

Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6. — View Citation

McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17. — View Citation

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. — View Citation

Morris BJ, Bailis SA, Wiswell TE. Circumcision rates in the United States: rising or falling? What effect might the new affirmative pediatric policy statement have? Mayo Clin Proc. 2014 May;89(5):677-86. doi: 10.1016/j.mayocp.2014.01.001. Epub 2014 Apr 2. Review. — View Citation

Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25. — View Citation

Nilsson S, Finnström B, Kokinsky E. The FLACC behavioral scale for procedural pain assessment in children aged 5-16 years. Paediatr Anaesth. 2008 Aug;18(8):767-74. doi: 10.1111/j.1460-9592.2008.02655.x. — View Citation

Sorokan ST, Finlay JC, Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee, Infectious Diseases and Immunization Committee. Newborn male circumcision. Paediatr Child Health. 2015 Aug-Sep;20(6):311-20. English, French. — View Citation

Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53. — View Citation

Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292. — View Citation

Willis MH, Merkel SI, Voepel-Lewis T, Malviya S. FLACC Behavioral Pain Assessment Scale: a comparison with the child's self-report. Pediatr Nurs. 2003 May-Jun;29(3):195-8. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of regional block on FLACC pain scores after circumcision	Impact of regional block on pain scores (FLACC score) during the 24 h post-operative period: at 5-30-60-120 minutes postoperative in hospital. The FLACC score (The Face, Legs, Activity, Cry, Consolability scale) The scale is scored in a range of 0-10 with 0 representing no pain. Will be used in the hospital at 5-30-60 and 120 minutes postop.	24 hours
Primary	Impact of regional block on PPPM pain scores after circumcision	Impact of regional block on PPPM pain scores (parent's postoperative pain measure) during the 24 h post-operative period at 6-12-24h postop at home.; PPPM score (parents' postoperative pain measure). The scale is scored in a range of 0-15 with 0 representing no pain. Scores 6 and higher represent significant pain. Will be used at home at 6-12-and 24h postop.	24 hours
Secondary	Impact of regional block on analgesic consumption after circumcision	Impact of regional block on analgesic consumption during the first 24h post-operative period.	24 hours