Skip to main content
OpenTrials
Completed

NCT Number: NCT02723487

Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.125%

Drug

Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.

Other names: Plain marcaine

Bupivacaine 0.25%

Drug

Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.

Other names: Plain marcaine

Primary outcomes

  1. pain score

    Time frame: 12 hours postoperative

    Children's Hospital Eastern Ontario Pain Scale

Secondary outcomes

  1. Total intraoperative fentanyl consumption

    Time frame: 12 hours postoperative

    Microgram (ug)

  2. number of participants with incidence of nausea

    Time frame: 12 hours postoperative

    number of patients

  3. number of participants with incidence of hematoma

    Time frame: 12 hours postoperative

    number of patients

  4. number of participants with incidence of infection

    Time frame: 12 hours postoperative

    number of patients

  5. Total postoperative paracetamol consumption

    Time frame: 12 hours postoperative

    Milligram (mg)

  6. Number of participants with incidence of vomiting

    Time frame: 12 hours postoperative

    number of patients

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.