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NCT Number: NCT05408403

Comparison of the Effects of 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.

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Key information

Conditions

Analgesia Acute Pain Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Medicine

Samsun, 55200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: Anterior Quadratus Lumborum Block

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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