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Transversus Abdominis Plane Versus Caudal Block for Pediatrics

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ClinicalTrials.gov Identifier: NCT02398123
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : September 16, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University

Tracking Information
First Submitted Date  ICMJE March 16, 2015
First Posted Date  ICMJE March 25, 2015
Last Update Posted Date September 16, 2015
Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
Time for first analgesic request [ Time Frame: 24 hours after surgery ]
By investigators until hospital discharge, then through telephone interview with parents after that
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • Total opioid consumption [ Time Frame: 24 hours after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that
  • Sedation level [ Time Frame: 12 hours after surgery ]
    Sedation level would be evaluated using a four-point sedation scale, 0=eyes open spontaneously, 1=eyes open to speech, 2=eyes open when shaken, 3=un arousable.
  • Parent satisfaction scores [ Time Frame: 24 hours after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that
  • Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS), [ Time Frame: 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane Versus Caudal Block for Pediatrics
Official Title  ICMJE Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
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.

Detailed Description

Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).

Anesthesia would be maintained with 2% sevoflurane and nitrous oxide.

An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h.

Children were transferred from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

Patients received rectal paracetamol 15 mg/ kg every 6 hours. Tramadol 1mg/kg is rescue analgesic.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lower Abdominal Surgery
Intervention  ICMJE
  • Other: Transversus abdominis plane block
    Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound
  • Other: Caudal block
    Children who received caudal 0.25% bupivacaine 1 mL/kg
  • Drug: Bupivacaine
Study Arms  ICMJE
  • Active Comparator: Transversus abdominis plane block
    Transversus Abdominis Plane block
    Interventions:
    • Other: Transversus abdominis plane block
    • Drug: Bupivacaine
  • Placebo Comparator: Caudal block
    Caudal block
    Interventions:
    • Other: Caudal block
    • Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2015)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children
  • Lower abdominal surgery

Exclusion Criteria:

  • Allergy to study medications
  • Contraindications to caudal block
  • Contraindications to transversus abdominis block
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02398123
Other Study ID Numbers  ICMJE MUH-Feb-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamed R El Tahan, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alaa Eldeeb, MD Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
PRS Account Mansoura University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP