NCT06627946

Brief Summary

The goal of this clinical trial is to learn if transversus abdominis plane (TAP) block will reduce the cumulative opioid consumption compared to local wound infiltration (WI). It will also learn about the pain scores compared between TAP and WI groups. The main questions it aims to answer are: Has the pain score after cesarean section been less in TAP compared to WI group? Has the cumulative consumption of opioids reduced in TAP as compared to WI group? Researchers will compare TAP group with WI group based on postoperative pain score and opioid used. Participants will: Be given intervention either TAP or WI during the cesarean section. Pain score will be recorded during the postoperative period at PACU, 6, 12 and 24 hours after cesarean section. The postoperative pain will be rescued with opioid, and the cumulative use of opioids will be recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

September 20, 2024

Last Update Submit

October 3, 2024

Conditions

Transversus Abdominis Plane (TAP) BlockWound InfiltrationPain Score (VAS)Opioid Analgesia

Keywords

transversus abdominis plane blockWound infiltration of local anesthesiapain scoreOpioid analgesiacesarean section

Outcome Measures

Primary Outcomes (1)

  • To compare cumulative consumption of opioids in the first 24 hours after cesarean section

    Cumulative use of Inj. morphine during the postoperative period was significantly less in the TAP group than in the WI group (5.4 ± 0.9 Vs 6.1 ± 0.6, p=0.017)

    within 24 hours postoperative period

Secondary Outcomes (2)

  • To compare the pain score using the Visual Analogue Scale between the intervention (TAP) and comparator (WI) group

    within 6, 12 and 24 hours postoperative period

  • To compare the postoperative complications between the intervention (TAP) group with the comparator (WI) group.

    Within first 24 hours postoperative period

Study Arms (2)

TAP group

EXPERIMENTAL

Local anesthesia 0.25% bupivacine 20ml was administered at the transversus abdominis plane in TAP group (experiment)

Procedure: TAP group

WI group

ACTIVE COMPARATOR

Local anesthesia 0.25% bupivacine 20ml was administered or infiltrated along the cesarean wound in WI group as a an active comparator

Procedure: TAP group

Interventions

TAP groupPROCEDURE

Local anesthesia 0.25% bupivacine was administered in the TAP plane

TAP groupWI group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All elective cesarean sections performed under spinal anesthesia,
  • American Society of Anesthesiologists physical status classification II (ASA II).

You may not qualify if:

  • Those mothers underwent emergency cesarean section
  • Contraindication to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
  • hypersensitivity to any of the drugs used in the study
  • Failed spinal anesthesia converted to general anesthesia
  • Pre-existing pain syndromes
  • History of recent opioid exposure
  • Significant cardiovascular, renal, or hepatic disease,
  • Fetal abnormalities or negative fetal outcomes were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeshey Dorjey

Phuentsholing, Phuentsholing, Chukha, 21001, Bhutan

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Yeshey Dorjey, MD

    Phuentsholing General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 4, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BH(1)