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

Primary Purpose

Analgesia, Acute Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Regional anesthesia TFPB
Regional anesthesia QLB
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring Regional Anesthesia, Acute and chronical pain, Transversalis Fascia Plane Block, Quadratus Lumborum Blocks, Cesarean Section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ondokuz Mayıs University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transversalis Fascia Plane Block

Quadratus Lumborum Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid consumption in the first 24 hours after surgery
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

Post-operative acute pain
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)
The time of first opioid requirement
The time of first opioid requirement will be recorded during the postoperative first 24 hours

Full Information

First Posted
June 1, 2022
Last Updated
November 8, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05408403
Brief Title
Comparison of the Effects of TFPB and Anterior QLB on Postoperative Analgesia in Cesarean Section Surgery
Official Title
Comparison of the Effects of Transversalis Fascia Plane Block and Anterior QLB ( TFPB and Anterior QLB ) on Postoperative Analgesia in Cesarean Section Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
September 18, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Acute Pain, Chronic Pain
Keywords
Regional Anesthesia, Acute and chronical pain, Transversalis Fascia Plane Block, Quadratus Lumborum Blocks, Cesarean Section

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer-generated randomization codes.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The anesthesia doctor who will perform the interfascial plane block (TFPB, anterior QLB) will be informed with a sealed envelope by an independent assistant outside the study, and the patient will not know which block is performed.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversalis Fascia Plane Block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Quadratus Lumborum Block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Regional anesthesia TFPB
Other Intervention Name(s)
Transversalis Fascia Plane Block
Intervention Description
Transversalis Fascia Plane Block will be performed with 25 mL of 0.25% bupivacaine,after the end of cesarean surgery before extubation.
Intervention Type
Other
Intervention Name(s)
Regional anesthesia QLB
Other Intervention Name(s)
Anterior Quadratus Lumborum Block
Intervention Description
Anterior Quadratus Lumborum Block will be performed with 25 mL of 0.25% bupivacaine, after the end of cesarean surgery before extubation.
Primary Outcome Measure Information:
Title
Opioid consumption in the first 24 hours after surgery
Description
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.
Time Frame
Postoperative Day 1
Secondary Outcome Measure Information:
Title
Post-operative acute pain
Description
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)
Time Frame
Postoperative Day 1
Title
The time of first opioid requirement
Description
The time of first opioid requirement will be recorded during the postoperative first 24 hours
Time Frame
Postoperative Day 1
Other Pre-specified Outcome Measures:
Title
The incidences of post-operative nausea and vomiting (PONV)
Description
the presence of nausea and vomiting will be recorded for 24 hours after surgery
Time Frame
Postoperative Day 1
Title
The incidence of side effects related to local anesthetics, opioid use and regional anesthesia technic
Description
respiratory depression, local anesthetic (LA) toxicity, hematoma and organ damage.
Time Frame
Postoperative Day 1

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women planned for elective cesarean operation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ondokuz Mayıs University Faculty of Medicine
City
Samsun
ZIP/Postal Code
55200
Country
Turkey

12. IPD Sharing Statement

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

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