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

October 31, 2023 updated by: SEZGİN BİLGİN, Ondokuz Mayıs University

Comparison of the Effects of Transversalis Fascia Plane Block and Anterior QLB ( TFPB and Anterior QLB ) on Postoperative Analgesia in Cesarean Section Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55200
        • Ondokuz Mayıs University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transversalis Fascia Plane Block
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
Other: Regional anesthesia TFPB
Transversalis Fascia Plane Block will be performed with 25 mL of 0.25% bupivacaine,after the end of cesarean surgery before extubation.
Other Names:
  • Transversalis Fascia Plane Block
Active Comparator: Quadratus Lumborum Block
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
Other: Regional anesthesia QLB
Anterior Quadratus Lumborum Block will be performed with 25 mL of 0.25% bupivacaine, after the end of cesarean surgery before extubation.
Other Names:
  • Anterior Quadratus Lumborum Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption in the first 24 hours after surgery
Time Frame: 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.
Postoperative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative acute pain
Time Frame: 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)
Postoperative Day 1
The time of first opioid requirement
Time Frame: Postoperative Day 1
The time of first opioid requirement will be recorded during the postoperative first 24 hours
Postoperative Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidences of post-operative nausea and vomiting (PONV)
Time Frame: Postoperative Day 1
the presence of nausea and vomiting will be recorded for 24 hours after surgery
Postoperative Day 1
The incidence of side effects related to local anesthetics, opioid use and regional anesthesia technic
Time Frame: Postoperative Day 1
respiratory depression, local anesthetic (LA) toxicity, hematoma and organ damage.
Postoperative Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Sezgin Bilgin, Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2022

Primary Completion (Actual)

September 18, 2022

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFPB-QLB3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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