Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children

NCT05233683 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-02-10

No results posted yet for this study

Summary

Circumcision is one of the most commonly performed operations in the pediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method (CDM). For intra-operative (OP) and post-OP pain relief, two commonly used local anesthetic techniques are caudal block (CB) and dorsal penile block (DPNB) plus ring block (RB) at the base of the penis. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.

Conditions

  • Anesthesia
  • Anesthesia, Local
  • Analgesia
  • Pediatric ALL
  • Pain, Postoperative
  • Pain, Acute

Interventions

DRUG

Caudal block

Caudal block will be performed in lateral position with 0.25% bupivacaine in the dose of 0.75 ml/kg containing 1 mic/kg dexmedetomidine. The patients will be turned back to the supine position after the block placement and the head of the patient will be placed in the neutral position. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

DRUG

Dorsal penile nerve block plus ring block

It will be performed with the child in the supine position. Following skin preparation and palpation of the arch of the lower border of the symphysis pubis, the base of the penis will be gently pulled down, and a 25-G needle will be inserted at 10 and 2.0 "O" clock position to a depth of 0.25-0.5 cm (under Bucks' fascia) and 1 ml + 0.1ml X weight of the patient) of local anesthetic (0.25% bupivacaine) will be injected at each point after negative aspiration and then RB will be done in the form of a circumferential subcutaneous ring at the level of the base of the penis. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

PROCEDURE

Circumcision with Plastibell

Circumcision with Plastibell

PROCEDURE

Conventional Dissection Method

Conventional Dissection Method

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Principal Investigators

  • Mansoor Aqil, FCPS · King Saud University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
4 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05233683 on ClinicalTrials.gov