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

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04049838

Collaborator

(none)

Enrollment

Location

Arms

9.6

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: postoperative analgesia for lower abdominal surgery in children	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized control studyrandomized control study

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 16, 2019

Anticipated Primary Completion Date :

Nov 5, 2019

Anticipated Study Completion Date :

Dec 5, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

postoperative pain assessment by the CHEOPS score [the first 24 hours postoperative]
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

Secondary Outcome Measures

heart rate [at 2,4,8,12 and 24 hours postoperative]
Measurement of heart rate (beats per minute)
Mean arterial blood pressure [at 2,4,8,12 and 24 hours postoperative]
Measurement of Mean arterial blood pressure ( mm Hg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al Aini	Cairo		Egypt	56545

Sponsors and Collaborators

Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Maher Kamel, lecture of anesthesia, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT04049838

Other Study ID Numbers:

011223456

First Posted:

Aug 8, 2019

Last Update Posted:

Oct 21, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Oct 21, 2019