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Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Primary Purpose

Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical TAP block
US guided TAP block
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Full term pregnant women Older than 21 years of age Had elective cesarean section with Pfannenstiel incision. Exclusion Criteria: Patients with cesarean section using different surgical incision History of addiction [including opioids and benzodiazepines] Allergy to the anesthetic analgesia Psychological disorders Coagulopathies Infection at the block injection site.

Sites / Locations

  • KohafRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgical TAP block

US guided TAP block

Arm Description

twenty-five pregnant women will receive surgical TAP block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.

25 pregnant women will receive US guided T.A.P block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.

Outcomes

Primary Outcome Measures

Time to perform block.
The time taken to perform the block will be recorded by an independent observer.

Secondary Outcome Measures

Heart rate
Patients hemodynamics (heart rate will be recorded)
Mean arterial blood pressure
Patients hemodynamics (mean arterial blood pressure will be recorded)
Pain score
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time to first analgesic request
The time to first analgesic request will be recorded
Amount of post operative analgesic consumption
The amount of post operative analgesic consumption will be recorded
Time spent in operating room
The time spent in operating room will be recorded
Incidence of Adverse reactions
Adverse events will be recorded such as nausea, vomiting, hypotension (Mean arterial blood pressure < 20% of baseline readings and will be managed by ephedrine 5 mg IV and/or normal saline IV) and bradycardia (heart rate < 60 beats/min and will be managed by atropine 0.6 mg IV).

Full Information

First Posted
February 19, 2023
Last Updated
August 4, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05750992
Brief Title
Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
Official Title
Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.
Detailed Description
Caesarean delivery rates have been increasing worldwide nowadays. At rate of [52%], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries. A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block, Bupivacaine, Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical TAP block
Arm Type
Active Comparator
Arm Description
twenty-five pregnant women will receive surgical TAP block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.
Arm Title
US guided TAP block
Arm Type
Active Comparator
Arm Description
25 pregnant women will receive US guided T.A.P block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.
Intervention Type
Procedure
Intervention Name(s)
surgical TAP block
Other Intervention Name(s)
bupivacaine, normal saline, fentanyl, pethidine
Intervention Description
performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.
Intervention Type
Procedure
Intervention Name(s)
US guided TAP block
Other Intervention Name(s)
bupivacaine, normal saline, fentanyl , pethidine
Intervention Description
performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.
Primary Outcome Measure Information:
Title
Time to perform block.
Description
The time taken to perform the block will be recorded by an independent observer.
Time Frame
1 hour postoperatively
Secondary Outcome Measure Information:
Title
Heart rate
Description
Patients hemodynamics (heart rate will be recorded)
Time Frame
24 hours postoperatively
Title
Mean arterial blood pressure
Description
Patients hemodynamics (mean arterial blood pressure will be recorded)
Time Frame
24 hours postoperatively
Title
Pain score
Description
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time Frame
24 hours postoperatively
Title
Time to first analgesic request
Description
The time to first analgesic request will be recorded
Time Frame
24 hours postoperatively
Title
Amount of post operative analgesic consumption
Description
The amount of post operative analgesic consumption will be recorded
Time Frame
24 hours postoperatively
Title
Time spent in operating room
Description
The time spent in operating room will be recorded
Time Frame
24 hours postoperatively
Title
Incidence of Adverse reactions
Description
Adverse events will be recorded such as nausea, vomiting, hypotension (Mean arterial blood pressure < 20% of baseline readings and will be managed by ephedrine 5 mg IV and/or normal saline IV) and bradycardia (heart rate < 60 beats/min and will be managed by atropine 0.6 mg IV).
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full term pregnant women Older than 21 years of age Had elective cesarean section with Pfannenstiel incision. Exclusion Criteria: Patients with cesarean section using different surgical incision History of addiction [including opioids and benzodiazepines] Allergy to the anesthetic analgesia Psychological disorders Coagulopathies Infection at the block injection site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neveen A. Kohaf, Ph.D
Phone
+201069482380
Email
nevenabdo@azhar.edu.eg
Facility Information:
Facility Name
Kohaf
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neveen A. Kohaf, Ph.D
Phone
01069482380

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the principle investigator
IPD Sharing Time Frame
for one year after completion of the study

Learn more about this trial

Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

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