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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
postoperative analgesia for lower abdominal surgery in children
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Postoperative

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Kasr Al AiniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

lateral transversus abdominis block

posterior tansversus abodominis plane block

convential analgesia

Arm Description

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

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

conventional analgesia in form of 1 micrograms. Kg-1 fentanyl and paracetamol 15 mg. Kg-1 suppositories

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

heart rate
Measurement of heart rate (beats per minute)
Mean arterial blood pressure
Measurement of Mean arterial blood pressure ( mm Hg)

Full Information

First Posted
July 21, 2019
Last Updated
October 18, 2019
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04049838
Brief Title
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children
Official Title
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children . Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2019 (Actual)
Primary Completion Date
November 5, 2019 (Anticipated)
Study Completion Date
December 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lateral transversus abdominis block
Arm Type
Active Comparator
Arm Description
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
Arm Title
posterior tansversus abodominis plane block
Arm Type
Active Comparator
Arm Description
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
Arm Title
convential analgesia
Arm Type
Active Comparator
Arm Description
conventional analgesia in form of 1 micrograms. Kg-1 fentanyl and paracetamol 15 mg. Kg-1 suppositories
Intervention Type
Procedure
Intervention Name(s)
postoperative analgesia for lower abdominal surgery in children
Intervention Description
compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children
Primary Outcome Measure Information:
Title
postoperative pain assessment by the CHEOPS score
Description
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
Time Frame
the first 24 hours postoperative
Secondary Outcome Measure Information:
Title
heart rate
Description
Measurement of heart rate (beats per minute)
Time Frame
at 2,4,8,12 and 24 hours postoperative
Title
Mean arterial blood pressure
Description
Measurement of Mean arterial blood pressure ( mm Hg)
Time Frame
at 2,4,8,12 and 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M Kamel, MD
Phone
01005238534
Email
mohamedmaher959@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S Helal, MD
Phone
01005287692
Email
a_s_helal@yahoo.com
Facility Information:
Facility Name
Kasr Al Aini
City
Cairo
ZIP/Postal Code
56545
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen M Ibrahim, MD
First Name & Middle Initial & Last Name & Degree
Noha Asem, MD
Phone
01003657120
Email
kasralainirec@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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