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

NCT05408403 | Completed

• 1 other identifier: TFPB-QLB3
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Acute Pain; Chronic Pain

Keywords

Regional Anesthesia; Acute and chronical pain; Transversalis Fascia Plane Block; Quadratus Lumborum Blocks; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative Day 1

Secondary Outcomes (2)

• Post-operative acute pain

  Postoperative Day 1

• The time of first opioid requirement

  Postoperative Day 1

Other Outcomes (2)

• The incidences of post-operative nausea and vomiting (PONV)

  Postoperative Day 1

• The incidence of side effects related to local anesthetics, opioid use and regional anesthesia technic

  Postoperative Day 1

Study Arms (2)

Transversalis Fascia Plane Block

ACTIVE COMPARATOR

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

Quadratus Lumborum Block

ACTIVE COMPARATOR

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

Interventions

Regional anesthesia TFPB OTHER

Transversalis Fascia Plane Block will be performed with 25 mL of 0.25% bupivacaine,after the end of cesarean surgery before extubation.

Also known as: Transversalis Fascia Plane Block

Transversalis Fascia Plane Block

Regional anesthesia QLB OTHER

Anterior Quadratus Lumborum Block will be performed with 25 mL of 0.25% bupivacaine, after the end of cesarean surgery before extubation.

Also known as: Anterior Quadratus Lumborum Block

Quadratus Lumborum Block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women planned for elective cesarean operation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Sezgin Bilgin

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: June 18, 2022
• Primary Completion: September 18, 2022
• Study Completion: November 8, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

TU (1)