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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

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.


Condition or disease Intervention/treatment Phase
Lower Abdominal Surgery Other: Transversus abdominis plane block Other: Caudal block Drug: Bupivacaine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: Transversus abdominis plane block
Transversus Abdominis Plane block
Other: Transversus abdominis plane block
Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound

Drug: Bupivacaine
Placebo Comparator: Caudal block
Caudal block
Other: Caudal block
Children who received caudal 0.25% bupivacaine 1 mL/kg

Drug: Bupivacaine



Primary Outcome Measures :
  1. Time for first analgesic request [ Time Frame: 24 hours after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that


Secondary Outcome Measures :
  1. Total opioid consumption [ Time Frame: 24 hours after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that

  2. 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.

  3. Parent satisfaction scores [ Time Frame: 24 hours after surgery ]
    By investigators until hospital discharge, then through telephone interview with parents after that

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children
  • Lower abdominal surgery

Exclusion Criteria:

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

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): NCT02398123


Locations
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Egypt
Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Alaa Eldeeb, MD Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
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Responsible Party: Mohamed R El Tahan, Associate Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT02398123    
Other Study ID Numbers: MUH-Feb-2015
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015
Keywords provided by Mohamed R El Tahan, Mansoura University:
Transversus Abdominis Plane
caudal block
postoperative pain
children
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents