NCT05117307

Brief Summary

Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

2 active sites

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 Progress72%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

November 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
4.1 years until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 4, 2021

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    Opioid consumption postroperative period

    Postoperative first 24 hours

Secondary Outcomes (1)

  • Visual Analog Pain Score

    Postoperative first 24 hours

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Drug: Bupivacaine 0.25% Injectable Solution

Group TFP

ACTIVE COMPARATOR

Ultrasound-guided Transversalis Fascia Plane Block block with 20 ml %0.25 bupivacaine, per side

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side

Group ESPGroup TFP

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-50 years
  • Cesarean Section

You may not qualify if:

  • Cesarean Section under general anesthesia
  • emergency cases
  • those with a body mass index greater than 35 kg/m2
  • coagulopathy
  • local infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erzurum Regional Training and Research Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Erzurum Regional Training and Research Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 11, 2021

Study Start

December 20, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations