Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery

NCT03498118 | Completed DMC

• 1 other identifier: aswu/200/2/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate pain control after cesarean delivery is a major concern both for parturient and for obstetric anesthesiologists, and it usually comprises a combination of systemic and regional techniques.The transversus abdominis plane (TAP) block, affecting the nerves supplying the anterior abdominal wall, is a recently introduced, promising regional analgesic technique for a variety of abdominal and pelvic surgeries including cesarean delivery.(2,3) Infiltration of local anesthetic into the surgical wound (either as a single shot or using indwelling catheters) has long been used for postoperative analgesia. Both the TAP block (4-6) and wound infiltration is superior to placebo; however, it is unknown which of them provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. Only 2 studies compared the TAP block with wound infiltration after cesarean delivery with conflicting results, and another study compared it with continuous wound infusion and was prematurely terminated. This study aimed to compare bilateral TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. We hypothesized that the TAP block would decrease postoperative cumulative opioid consumption at 24 hours

Conditions

Cesarean Section

Keywords

Transversus Abdominis Plane Block; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• pain score after cesarean section in the first 24 hour posoperative

  pain score after cesarean section in the first 24 hour posoperative

  24 hours post operaive

Secondary Outcomes (1)

• cumulative opioid consumption at 24 hours

  24 hours post operaive

Study Arms (2)

Transversus Abdominis Plane Block group

EXPERIMENTAL

after completion of surgery, 20 mL of bupivacaine 0.25% was injected under direct visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.

Drug: 20 mL of bupivacaine 0.25%

Wound Infiltration group

ACTIVE COMPARATOR

at the end of surgery, 30 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (15 mL in each of the upper and lower sides) by the obstetrician before skin closure

Drug: 20 mL of bupivacaine 0.25%

Interventions

20 mL of bupivacaine 0.25% DRUG

In the infiltration group, at the end of surgery, 30 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL in each of the upper and lower sides) by the obstetrician before skin closure. Sam procedure was performed by the primary investigator after completion of surgery by pressing a covered spinal needle on both sides of the patient's abdomen. In the TAP group, after completion of surgery, 20 mL of bupivacaine 0.25% was injected under direct visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.

Also known as: 30 mL of bupivacaine 0.25%

Transversus Abdominis Plane Block group; Wound Infiltration group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible subjects were American Society of Anesthesiologists physical status I, II parturient with full-term singleton pregnancies undergoing elective cesarean delivery under spinal anesthesia

You may not qualify if:

• were: \<19 years of age or \>40 years of age; height \<150 cm, weight \<60 kg, body mass index (BMI) \>=40 kg/m2; contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection); history of recent opioid exposure; hypersensitivity to any of the drugs used in the study; significant cardiovascular, renal, or hepatic disease; and known fetal abnormalities

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participants will be blinded to the medication type, which will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 13, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)