Comparison of the Quality of Recovery After Cesarean Section Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Abdominal Pain, Postoperative Recovery, Cesarean Section

Intervention / Treatment
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* Procedure: Transversalis Fascia Plane Block
* Procedure: Transversus Abdominis Plane Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status II-III Cesarean section surgery under spinal anesthesia Exclusion Criteria: American Society of Anesthesiologists physical status IV Emergency surgery General anesthesia Additional surgical intervention at the same session Body mass index of more than 35 kg/m2 Allergy to any study drugs Local infection at the injection site History of drug abuse Communication problem Coagulopathy Preeclampsia and eclampsia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transversalis Fascia Plane Block (TFPB) Group<br>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<br>* 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<br>|
| Active Comparator: Transversus Abdominis Plane (TAP) Block Group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of recovery | Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score | Postoperative 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | 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 | Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour | 
| Numeric Rating Scale | 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) | Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour | 
| Adverse Reactions | Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed | Postoperative 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section surgery, postoperative recovery, postoperative pain, trasversalis fascia plane block, transversus abdominis plane block, obstetric quality of recovery 11 Turkish score, numeric rating scale