NCT07478692

Brief Summary

ltrasound-guided transversus abdominis plane (TAP) block is an emerging local anesthesia technique that effectively alleviates postoperative pain by injecting anesthetic drugs around the nerves in the abdominal wall. Compared with traditional analgesic methods, TAP blockade may have better analgesic effects and fewer side effects. However, current research on the application of TAP blockade after cesarean section is still limited. Therefore, this study will systematically evaluate its actual effectiveness in pain management after cesarean section through a prospective randomized controlled trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 7, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS pain scores (0-10 scale, where 0 = no pain and 10 = unbearable severe pain) at rest and during activity ( Time to first rescue analgesia requirement and number of patients and total dosage of flurbiprofen axetil used within 48 hours postoperatively;

    VAS pain scores (0-10 scale, where 0 = no pain and 10 = unbearable severe pain) at rest and during activity (coughing or turning) at 2, 6, 12, 24, and 48 hours postoperatively were recorded by anesthesiologists not involved in this study.

    5 months

Study Arms (2)

TAP Block Group

EXPERIMENTAL

The TAP block group received ultrasound-guided bilateral TAP block (20 mL of 0.375 % ropivacaine per side) during surgery and postoperative intravenous analgesia pump (formula of butorphanol 2 mg/kg + tropisetron 8 mg);

Drug: The TAP block group received ultrasound-guided bilateral TAP block (20 mL of 0.375 % ropivacaine per side) during surgery and postoperative intravenous analgesia pump (formula of butorphanol 2 mg/kg)

the control group

NO INTERVENTION

received only the same formula intravenous analgesia pump. For both groups, rescue

Interventions

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 20-40 years, in good general health
  • ASA physical status I-II
  • Singleton, term (37-41 weeks) pregnancy with normal fetal development
  • Planned for elective cesarean section, no labor

You may not qualify if:

  • Pregnancy complications (e.g., severe preeclampsia, gestational diabetes, placental abruption)
  • Major organ dysfunction (heart, liver, kidney) or psychiatric history
  • Allergy to local anesthetics or any study drugs
  • Prior abdominal surgery or infection that may affect block efficacy
  • Coagulation disorders or current anticoagulant use
  • Refusal to participate or inability to comply with follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shandong Provincial Maternal and Child Health Care Hospital

Jinan, Shandong, 250014, China

Location

Shandong Provincial Maternal and Child Health Care Hospital

Jinan, Shandong, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shandong Provincial Maternal and Child Health Care Hospital

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 17, 2026

Study Start

June 1, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations