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Trial record 22 of 496 for:    penis

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

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ClinicalTrials.gov Identifier: NCT03914365
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Moore, CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Male Circumcision Regional Anesthesia Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized blinded parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Ultrasound-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block for Analgesia Following Pediatric Circumcision
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914365


Contacts
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Contact: Katherine Moore, MD 418-654-2282 katherine.moore.1@ulaval.ca
Contact: Ariane Boivin, md 418-525-4444 ariane.boivin.2@ulaval.ca

Locations
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Canada
CHU de Québec Recruiting
Québec, Canada, G1V 4G2
Contact: Katherine Moore    4186542282      
Sponsors and Collaborators
CHU de Quebec-Universite Laval

Publications:

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Responsible Party: Katherine Moore, Md FRCSC Pediatric Urologist, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03914365     History of Changes
Other Study ID Numbers: 2018-4132
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katherine Moore, CHU de Quebec-Universite Laval:
Circumcision
Penile block
Pudendal block
Pediatric