NCT05758233

Brief Summary

The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia. The main question\[s\] it aims to answer are: \[Is transversalis fascia plane block more effective in postoperative analgesia? \] \[Is there a difference between the duration of postoperative first analgesia requirement? \] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

February 20, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

anesthesia recovery periodcesarean sectionobstetric anesthesiaspinal anaesthesiapostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • time of first analgesic need

    Our primary goal was to meet the initial analgesic requirement times.

    24 hours postoperatively

Secondary Outcomes (1)

  • visuel analog scale

    24 hours postoperatively

Study Arms (2)

Grup 1: Transversalis Fascia Plane Block (TFPB)

EXPERIMENTAL

Transversalis Fascia Plane Block (TFPB)

Procedure: Patients undergoing transversalis fascia plane blockProcedure: Patients undergoing transversus abdominis plane block

Grup 2: Transversus Abdominis Plane Block (TAPB)

EXPERIMENTAL

Transversus Abdominis Plane Block (TAPB)

Procedure: Patients undergoing transversalis fascia plane blockProcedure: Patients undergoing transversus abdominis plane block

Interventions

The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.

Grup 1: Transversalis Fascia Plane Block (TFPB)Grup 2: Transversus Abdominis Plane Block (TAPB)

The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.

Grup 1: Transversalis Fascia Plane Block (TFPB)Grup 2: Transversus Abdominis Plane Block (TAPB)

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details20-50 age
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old pregnant woman
  • ASAII-III
  • Patients accepting spinal anesthesia

You may not qualify if:

  • Morbid obesity(BMI \>40)
  • Patients who are switched to general anesthesia in an unexpected perioperative situation
  • Patients with placental anomaly
  • Patients with bupivacaine allergy
  • Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, 3268, Turkey (Türkiye)

Location

Related Publications (2)

  • Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.

    PMID: 35455750BACKGROUND
  • Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.

MeSH Terms

Conditions

CoitusAgnosia

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Duygu Akyol, M.D

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
prospective randomize study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective randomize study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 7, 2023

Study Start

January 4, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations