Transversus Abdominis Plane Versus Caudal Block for Pediatrics

NCT02398123 | Completed Phase 1 DMC

• 1 other identifier: MUH-Feb-2015
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The transversus abdominis plane (TAP) block is a relatively simple technique that provides myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in the prevention and treatment of parietal postoperative pain. Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided technique in different surgical procedures such as cesarean section, appendicectomy, laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients. Recently published clinical trials suggest that TAP block may represents an effective alternative to epidural anesthesia but further studies in larger population are necessary. Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal laparotomy (2). Others found comparable results between continuous transversus abdominis plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing effects, technical simplicity, and long duration of action. Some disadvantages include the need for bilateral block for midline incisions and absence of effectiveness for visceral pain (4). TAP block has been associated with good pain relief and decreased intraoperative and postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of the TAP block has been demonstrated in prospective randomized trials compared with placebo, in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8, 9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in terms of reduction in visual analogue scale scores and morphine consumption. In this study the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block for postoperative pain control after lower abdominal surgeries in pediatrics.

Conditions

Lower Abdominal Surgery

Keywords

Transversus Abdominis Plane; caudal block; postoperative pain; children

Outcome Measures

Primary Outcomes (1)

• Time for first analgesic request

  By investigators until hospital discharge, then through telephone interview with parents after that

  24 hours after surgery

Secondary Outcomes (4)

• Total opioid consumption

  24 hours after surgery

• Sedation level

  12 hours after surgery

• Parent satisfaction scores

  24 hours after surgery

• Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS),

  2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery

Study Arms (2)

Transversus abdominis plane block

ACTIVE COMPARATOR

Transversus Abdominis Plane block

Other: Transversus abdominis plane block; Drug: Bupivacaine

Caudal block

PLACEBO COMPARATOR

Caudal block

Other: Caudal block; Drug: Bupivacaine

Interventions

Transversus abdominis plane block OTHER

Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound

Transversus abdominis plane block

Caudal block OTHER

Children who received caudal 0.25% bupivacaine 1 mL/kg

Caudal block

Bupivacaine DRUG

Caudal block; Transversus abdominis plane block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children
• Lower abdominal surgery

You may not qualify if:

• Allergy to study medications
• Contraindications to caudal block
• Contraindications to transversus abdominis block

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alaa Eldeeb, MD

  Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

EG (1)