Comparison of the Effects of TFPB and Anterior QLB on Postoperative Analgesia in Cesarean Section Surgery

Not Applicable

Completed

• Conditions: Acute Pain; Analgesia; Chronic Pain
• Interventions: Other: Regional anesthesia TFPB; Other: Regional anesthesia QLB

• Registration Number: NCT05408403
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

This study evaluates the postoperative analgesic effects of transversalis fascia plane block and anterior quadratus lumborum block in patients having cesarean section under general anesthesia. General anesthesia will be performed to all patients for the surgery.

Detailed Description

In this study, patients are divided into two groups. After the general anesthesia is performed and cesarean section surgery is over; TFPB block will be performed to patients in Group A ; while anterior QLB block will be performed to patients in Group B. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group A - Patients in group A will have TFPB block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group B - Patients in group B will have anterior QLB block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Study Start: 2022-06-18
• Primary Completion: 2022-09-18
• Study Completion: 2022-11-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

• Being pregnant for at least 37 weeks
• Planning an elective cesarean operation
• Being between the ages of 18-45

Exclusion Criteria

• American Society of Anesthesiologists (ASA) 3-4 patients with comorbidities (Serious renal, cardiac, hepatic disease)
• Being operated with spinal anesthesia
• Obesity (> 100 kg, BMI> 35 kg / m2)
• Contraindication of regional anesthesia (coagulopathy, abnormal international normalized ratio (INR), thrombocytopenia, infection at the injection site)
• Hypersensitivity to local anesthetics or a history of allergy
• Patients with a history of opioid use longer than four weeks
• Patients with psychiatric disorders
• Patients with anatomic deformity
• Patients who do not want to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversalis Fascia Plane Block	Regional anesthesia TFPB	Transversalis Fascia Plane Block (TFPB) will be performed the patients in Group A after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively
Quadratus Lumborum Block	Regional anesthesia QLB	Anterior Quadratus Lumborum Block ( Anterior QLB) will be performed the patients in Group B after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively

Primary Outcome Measures

Name	Time	Method
Opioid consumption in the first 24 hours after surgery	Postoperative Day 1	Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA). Patients will be able to request opioids via PCA device when the nrs score is above 4.

Secondary Outcome Measures

Name	Time	Method
The time of first opioid requirement	Postoperative Day 1	The time of first opioid requirement will be recorded during the postoperative first 24 hours
Post-operative acute pain	Postoperative Day 1	Pain status will be evaluated based on numeric rating scale (NRS) scores at rest and after movement. Pain status will be evaluated at 1, 3, 6, 9, 12, 18, 24. hours after surgery. Each NRS is scores 0-10. (0=no pain ; 10=worst pain imaginable)

Trial Locations

Locations (1)

Ondokuz Mayıs University Faculty of Medicine; 🇹🇷 Samsun, Turkey