TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT

Obstetric Pain Clinical Trial

Official title:

the Efficacy of Transversus Abdominis Plane Block for Analgesia in Comparison With Local Anesthetic Wound Infiltration Post-cesarean Section: A Randomized Comparative Double-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637386
• Other study ID #: MD-300-2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 15, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.

2. Aged =19 years and less than 40 years.

3. Gestational age = 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) =40 kg/m2.

2. History of recent opioid exposure

3. Hypersensitivity to any of the drugs used in the study.

4. Significant cardiovascular, renal, or hepatic disease

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Anesthesia Problems
• Obstetric Pain

Intervention

Procedure:
• Transversus Abdominis Plane Block
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.
• Local anesthetic wound infiltration
40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure

Locations

Country	Name	City	State
Egypt	faculty of medicine - Cairo university	Cairo	Kasr El Ainy

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively	, using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain).	24 hours
Secondary	measures the time to the first postoperative opioid dose	time interval from postoperative till first dose of opioid	24 hours