NCT04049838

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

July 21, 2019

Last Update Submit

October 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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: 1. crying 2. facial expression 3. child verbal expression 4. body positiion 5. touching or grabbing at wound 6. 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 Outcomes (2)

  • heart rate

    at 2,4,8,12 and 24 hours postoperative

  • Mean arterial blood pressure

    at 2,4,8,12 and 24 hours postoperative

Study Arms (3)

lateral transversus abdominis block

ACTIVE COMPARATOR

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

posterior tansversus abodominis plane block

ACTIVE COMPARATOR

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

convential analgesia

ACTIVE COMPARATOR

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

Interventions

compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children

convential analgesialateral transversus abdominis blockposterior tansversus abodominis plane block

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Aini

Cairo, 56545, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Mohamed M Kamel, MD

CONTACT

Ahmed S Helal, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of anesthesia

Study Record Dates

First Submitted

July 21, 2019

First Posted

August 8, 2019

Study Start

February 16, 2019

Primary Completion

November 5, 2019

Study Completion

December 5, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations