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

NCT03914365 | Unknown DMC

• 1 other identifier: 2018-4132
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Male Circumcision; Regional Anesthesia

Keywords

Circumcision; Penile block; Pudendal block; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Impact of regional block on analgesic consumption after circumcision

  24 hours

Study Arms (2)

Ultrasound-guided pudendal nerve block (PNB)

ACTIVE COMPARATOR

Standard circumcision under general anaesthesia with ultrasound-guided pudendal nerve block.Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed, 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 tech-nique, 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 posi-tioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropiva-caine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side.

Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)

Ultrasound-guided penile nerve block (DPNB)

ACTIVE COMPARATOR

Standard circumcision under general anaes-thesia with ultrasound-guided penile nerve block.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.

Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)

Interventions

Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) PROCEDURE

Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.

Ultrasound-guided penile nerve block (DPNB); Ultrasound-guided pudendal nerve block (PNB)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec

Québec, G1V 4G2, Canada

Location

Related Publications (21)

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• Boisvert-Moreau F, Turcotte B, Albert N, Singbo N, Moore K, Boivin A. Randomized controlled trial (RCT) comparing ultrasound-guided pudendal nerve block with ultrasound-guided penile nerve block for analgesia during pediatric circumcision. Reg Anesth Pain Med. 2023 Mar;48(3):127-133. doi: 10.1136/rapm-2022-103785. Epub 2022 Nov 17.

  PMID: 36396298 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Five regional anesthesia experienced anesthesiologists not involved in the subsequent intraoperative or postoperative care of the patient will perform blocks. Pain scores using the FLACC score(16) will be recorded in the PACU and ambulatory step down unit at 5, 30, 60 and 120 minutes postoperatively by trained and blinded nurses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md FRCSC Pediatric Urologist

Model Details: Randomized blinded parallel assignment

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: July 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)