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

Sponsor

Ondokuz Mayıs University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05408403

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Acute Pain Chronic Pain	Other: Regional anesthesia TFPB Other: Regional anesthesia QLB	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Jun 18, 2022

Anticipated Primary Completion Date :

Aug 18, 2022

Anticipated Study Completion Date :

Sep 18, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Opioid consumption in the first 24 hours after surgery [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 Outcome Measures

Post-operative acute pain [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)
The time of first opioid requirement [Postoperative Day 1]
The time of first opioid requirement will be recorded during the postoperative first 24 hours

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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