Clinical trial NCT05999981: Comparison of the Quality of Recovery After Cesarean Section Surgery
Official title: Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative quality of recovery
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
measure: Numeric Rating Scale
timeFrame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
measure: Adverse Reactions
timeFrame: Postoperative 24th hour
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Training and Research Hospital
Study officials:
affiliation: Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
name: Melike Korkmaz Toker, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.