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Clinical Trials/NCT02723487
NCT02723487
Completed
Phase 2

Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery

Abdelrady S Ibrahim, MD1 site in 1 country60 target enrollmentApril 2016

Overview

Phase
Phase 2
Intervention
Bupivacaine 0.125%
Conditions
Postoperative Pain
Sponsor
Abdelrady S Ibrahim, MD
Enrollment
60
Locations
1
Primary Endpoint
pain score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

Detailed Description

A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia. After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles. After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side . Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg. The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Abdelrady S Ibrahim, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Abdelrady S Ibrahim, MD

Assistant professor of Anesthesia and Intensive care

Assiut University

Eligibility Criteria

Inclusion Criteria

  • ASA I-II physical status patients.
  • Genders Eligible for Study :male.
  • All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
  • Duration of Laparoscopic procedure not exceeding 90 minutes.
  • Written informed consent from parent of guardian .

Exclusion Criteria

  • Sensitivities to local anesthetics.
  • Significant renal, liver, or cardiac disease.
  • Surgery requiring an open procedure

Arms & Interventions

Group B

patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.

Intervention: Bupivacaine 0.125%

Group C

patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.

Intervention: Bupivacaine 0.25%

Outcomes

Primary Outcomes

pain score

Time Frame: 12 hours postoperative

Children's Hospital Eastern Ontario Pain Scale

Secondary Outcomes

  • Total intraoperative fentanyl consumption(12 hours postoperative)
  • number of participants with incidence of infection(12 hours postoperative)
  • Total postoperative paracetamol consumption(12 hours postoperative)
  • Number of participants with incidence of vomiting(12 hours postoperative)
  • number of participants with incidence of nausea(12 hours postoperative)
  • number of participants with incidence of hematoma(12 hours postoperative)

Study Sites (1)

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