Comparison of the Quality of Recovery After Cesarean Section Surgery

Sponsor

Muğla Sıtkı Koçman University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05999981

Collaborator

(none)

Enrollment

Location

Arms

2.3

Anticipated Duration (Months)

34.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Recovery Abdominal Pain Cesarean Section	Procedure: Transversalis Fascia Plane Block Procedure: Transversus Abdominis Plane Block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery

Anticipated Study Start Date :

Aug 24, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transversalis Fascia Plane Block (TFPB) Group At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.	Procedure: Transversalis Fascia Plane Block 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally
Active Comparator: Transversus Abdominis Plane (TAP) Block Group At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.	Procedure: Transversus Abdominis Plane Block 40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally

Arm

Intervention/Treatment

Active Comparator: Transversalis Fascia Plane Block (TFPB) Group

At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.

Procedure: Transversalis Fascia Plane Block

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally

Active Comparator: Transversus Abdominis Plane (TAP) Block Group

At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.

Procedure: Transversus Abdominis Plane Block

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally

Outcome Measures

Primary Outcome Measures

Postoperative quality of recovery [Postoperative 24th hour]
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score

Secondary Outcome Measures

Postoperative opioid consumption [Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour]
Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Numeric Rating Scale [Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour]
A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Adverse Reactions [Postoperative 24th hour]
Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed