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Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

Phase 2
Completed
Conditions
Postoperative Pain
Interventions
Registration Number
NCT02723487
Lead Sponsor
Abdelrady S Ibrahim, MD
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group BBupivacaine 0.125%patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
Group CBupivacaine 0.25%patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Primary Outcome Measures
NameTimeMethod
pain score12 hours postoperative

Children's Hospital Eastern Ontario Pain Scale

Secondary Outcome Measures
NameTimeMethod
Total postoperative paracetamol consumption12 hours postoperative

Milligram (mg)

Total intraoperative fentanyl consumption12 hours postoperative

Microgram (ug)

number of participants with incidence of infection12 hours postoperative

number of patients

Number of participants with incidence of vomiting12 hours postoperative

number of patients

number of participants with incidence of nausea12 hours postoperative

number of patients

number of participants with incidence of hematoma12 hours postoperative

number of patients

Trial Locations

Locations (1)

Assiut university faculty of medicine

🇪🇬

Assiut, Egypt

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