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

August 4, 2021 updated by: Katherine Moore, CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G2
        • CHU de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-guided pudendal nerve block (PNB)
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)
Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.
Active Comparator: Ultrasound-guided penile nerve block (DPNB)
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)
Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of regional block on FLACC pain scores after circumcision
Time Frame: 24 hours
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
Time Frame: 24 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of regional block on analgesic consumption after circumcision
Time Frame: 24 hours
Impact of regional block on analgesic consumption during the first 24h post-operative period.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-4132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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