Comparison of the Quality of Recovery After Cesarean Section Surgery

NCT05999981 | Completed

• 1 other identifier: MSKU 13-IV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery; Abdominal Pain; Cesarean Section

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative opioid consumption

  Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour

• Numeric Rating Scale

  Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour

• Adverse Reactions

  Postoperative 24th hour

Study Arms (2)

Transversalis Fascia Plane Block (TFPB) Group

ACTIVE COMPARATOR

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

Transversus Abdominis Plane (TAP) Block Group

ACTIVE COMPARATOR

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

Interventions

Transversalis Fascia Plane Block PROCEDURE

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

Transversalis Fascia Plane Block (TFPB) Group

Transversus Abdominis Plane Block PROCEDURE

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

Transversus Abdominis Plane (TAP) Block Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status II-III
• Cesarean section surgery under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Training and Research Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (3)

• Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.

  PMID: 29759061 BACKGROUND

• Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.

  PMID: 32412986 BACKGROUND

• Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.

  PMID: 39039833 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes

Study Officials

• Melike Korkmaz Toker, Associate Professor

  Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: August 24, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 2, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)