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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408403
• Other study ID #: TFPB-QLB3
• Status: Completed
• Phase: N/A
• Start date: June 18, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: October 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 8, 2022
• Est. primary completion date: September 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University Faculty of Medicine	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidences of post-operative nausea and vomiting (PONV)	the presence of nausea and vomiting will be recorded for 24 hours after surgery	Postoperative Day 1
Other	The incidence of side effects related to local anesthetics, opioid use and regional anesthesia technic	respiratory depression, local anesthetic (LA) toxicity, hematoma and organ damage.	Postoperative Day 1
Primary	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	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)	Postoperative Day 1
Secondary	The time of first opioid requirement	The time of first opioid requirement will be recorded during the postoperative first 24 hours	Postoperative Day 1