- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874168
The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (TAPBLOCK)
The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Gamal Elnajar, MD
- Phone Number: 0201092672757
- Email: a7medgamal2020.ag@gmail.com
Study Locations
-
-
Alabbasia
-
Cairo, Alabbasia, Egypt
- Recruiting
- ain shams University
-
Contact:
- ahmed G elnajar, md
- Phone Number: 0201092672757
- Email: a7medgamal2020.ag@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women undergoing cesarean section under spinal anesthesia
- Aged ≥19 years and > 40 years .
- Gestational age ≥ 37 Weeks .
- Informed Consent From the Patient .
Exclusion Criteria:
- Body mass index (BMI) ≥40 kg/m2 ..
- History of recent opioid exposure .
- Hypersensitivity to any of the drugs used in the study .
- Significant cardiovascular, renal, or hepatic disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: In the TAP group (Group A )
after completion of surgery, bilateral ultrasound-guided TAP block was performed . Description of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side. |
bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used
Other Names:
|
ACTIVE_COMPARATOR: In the infiltration group (Group B )
at the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure.
|
bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used
Other Names:
|
PLACEBO_COMPARATOR: In placebo group (Group C )
routine analgesic was administered and recorded .
|
bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of pain at rest ;
Time Frame: From 2 hours to 24 hours postoperatively
|
using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis.
(0 = no pain and 10 = the worst possible pain) .
|
From 2 hours to 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The time to the first postoperative opioid dose
Time Frame: at 2, 4, 6, and 12 hours.
|
cumulative opioid consumption
|
at 2, 4, 6, and 12 hours.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of pain on movement (hip flexion and coughing)
Time Frame: From 2 hours to 24 hours postoperatively
|
using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis.
(0 = no pain and 10 = the worst possible pain) .
|
From 2 hours to 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed G Elnajar, MD, ain shams University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- tapblockvwoundInfiltration
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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