Comparison of the Quality of Recovery After Cesarean Section Surgery

Not Applicable

Completed

• Conditions: Abdominal Pain; Cesarean Section; Postoperative Recovery
• Interventions: Procedure: Transversalis Fascia Plane Block; Procedure: Transversus Abdominis Plane Block

• Registration Number: NCT05999981
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2023-08-24
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-02
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiologists physical status II-III
• Cesarean section surgery under spinal anesthesia

Exclusion Criteria

• American Society of Anesthesiologists physical status IV
• Emergency surgery
• General anesthesia
• Additional surgical intervention at the same session
• Body mass index of more than 35 kg/m2
• Allergy to any study drugs
• Local infection at the injection site
• History of drug abuse
• Communication problem
• Coagulopathy
• Preeclampsia and eclampsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversalis Fascia Plane Block (TFPB) Group	Transversalis Fascia Plane Block	At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.
Transversus Abdominis Plane (TAP) Block Group	Transversus Abdominis Plane Block	At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.

Primary Outcome Measures

Name	Time	Method
Postoperative quality of recovery	Postoperative 24th hour	Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour	Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Numeric Rating Scale	Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour	A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Adverse Reactions	Postoperative 24th hour	Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed

Trial Locations

Locations (1)

Mugla Sıtkı Kocman University Training and Research Hospital; 🇹🇷 Mugla, Turkey