NCT07616180

Brief Summary

Cesarean section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of peripheral nerve blocks such as the transversus abdominis plane block. The TAP block is a fascial plane block that provides analgesia by depositing local anaesthetic between the internal oblique and transversus abdominis muscles. Its efficacy after cesarean section has been demonstrated, particularly when long-acting intrathecal opioids are not used. However, the optimal local anaesthetic volume and dose remain unclear. Since the TAP block depends on adequate spread of local anaesthetic, larger volumes may improve analgesic coverage, but increasing the dose may raise the risk of systemic toxicity. Therefore, this study investigates whether using the same fixed mass of bupivacaine in two different volumes affects the analgesic efficacy of TAP block after cesarean section, hypothesising that the larger volume may provide better postoperative analgesia.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
4mo left

Started Jun 2026

Shorter than P25 for phase_4

Status
not yet recruiting

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 Progress8%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

May 16, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 16, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • total postoperative morphine consumption

    first 24 hours postoperatively

Study Arms (2)

Fixed-mass, high-volume bupivacaine TAP block

EXPERIMENTAL

Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 60 mL, injected as 30 mL per side.

Drug: Bupivacaine

Fixed-mass, low-volume bupivacaine TAP block

EXPERIMENTAL

Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 120 mL, injected as 60 mL per side.

Drug: Bupivacaine

Interventions

Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section. The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side

Fixed-mass, high-volume bupivacaine TAP block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • full-term parturients,
  • aged \> 18 years
  • ASA physical status II
  • patients who are scheduled for elective CS with Pfannenstiel incisions under spinal anaesthesia.

You may not qualify if:

  • Parturients with contraindications to spinal anaesthesia,
  • Having a scar or infection at the site of the block
  • BMI \> 35 Kg/m2,
  • on chronic use of pain medications,
  • Refusing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2026

First Posted

June 1, 2026

Study Start

June 6, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share