Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children

Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children . Randomized Controlled Trial

Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: postoperative analgesia for lower abdominal surgery in children

Detailed Description

the investigators will compare the effect of posterior Transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 56545
    • Recruiting
    • Kasr Al Aini
    • Contact: Mohsen M Ibrahim, MD
    • Contact: Noha Asem, MD; Phone Number: 01003657120; Email: kasralainirec@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children from 1- 7 years
• scheduled to undergo lower abdominal surgery

Exclusion Criteria:

• bleeding disorders
• emergency surgery
• skin lesion at site of needle insertion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lateral transversus abdominis block; patients will take lateral transversus abdominis plan block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1	Procedure: postoperative analgesia for lower abdominal surgery in children; compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children
Active Comparator: posterior tansversus abodominis plane block; patients will take posterior transversus abdominis plane block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1	Procedure: postoperative analgesia for lower abdominal surgery in children; compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children
Active Comparator: convential analgesia; conventional analgesia in form of 1 micrograms. Kg-1 fentanyl and paracetamol 15 mg. Kg-1 suppositories	Procedure: postoperative analgesia for lower abdominal surgery in children; compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain assessment by the CHEOPS score	Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) for Post-Op Pediatric Pain the score is based on 6 crtiteria: crying; facial expression; child verbal expression; body positiion; touching or grabbing at wound; legs position criterion 1 is given a score of 1-3, criterion 2 and 3 are given score 0-2, criterion 4,5 and 6 are given a score 1-2 making the worst possible score 13 while the least possible score is 4. a total score of 6 or less indicates adequate analgesia	the first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	Measurement of heart rate (beats per minute)	at 2,4,8,12 and 24 hours postoperative
Mean arterial blood pressure	Measurement of Mean arterial blood pressure ( mm Hg)	at 2,4,8,12 and 24 hours postoperative

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2019
• Primary Completion (Anticipated): November 5, 2019
• Study Completion (Anticipated): December 5, 2019

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 011223456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No