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Completed

NCT Number: NCT05999981

Comparison of the Quality of Recovery After Cesarean Section Surgery

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.

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Key information

Conditions

Postoperative Recovery Abdominal Pain Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sıtkı Kocman University Training and Research Hospital

Muğla, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Postoperative quality of recovery

    Time frame: Postoperative 24th hour

    Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: 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

  2. Numeric Rating Scale

    Time frame: 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)

  3. Adverse Reactions

    Time frame: Postoperative 24th hour

    Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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