Comparison of the Quality of Recovery After Cesarean Section Surgery

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999981
• Other study ID #: MSKU 13-IV
• Status: Completed
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: November 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Cesarean Section
• Postoperative Recovery

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Training and Research Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Adverse Reactions	Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed	Postoperative 24th hour