- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398123
Transversus Abdominis Plane Versus Caudal Block for Pediatrics
Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
DK
-
Mansoura, DK, Egypt, 050
- Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children
- Lower abdominal surgery
Exclusion Criteria:
- Allergy to study medications
- Contraindications to caudal block
- Contraindications to transversus abdominis block
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transversus abdominis plane block
Transversus Abdominis Plane block
|
Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound
|
Placebo Comparator: Caudal block
|
Children who received caudal 0.25% bupivacaine 1 mL/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for first analgesic request
Time Frame: 24 hours after surgery
|
By investigators until hospital discharge, then through telephone interview with parents after that
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total opioid consumption
Time Frame: 24 hours after surgery
|
By investigators until hospital discharge, then through telephone interview with parents after that
|
24 hours after surgery
|
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.
|
12 hours after surgery
|
Parent satisfaction scores
Time Frame: 24 hours after surgery
|
By investigators until hospital discharge, then through telephone interview with parents after that
|
24 hours after surgery
|
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
|
2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alaa Eldeeb, MD, Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUH-Feb-2015
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