Clinical trial NCT05758233: The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section
Official title: Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Sexual
Analgesia
Keywords: anesthesia recovery period
cesarean section
obstetric anesthesia
spinal anaesthesia
postoperative analgesia
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomize study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.

The main question\[s\] it aims to answer are:

\[Is transversalis fascia plane block more effective in postoperative analgesia? \]

\[Is there a difference between the duration of postoperative first analgesia requirement? \] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.

Detailed description: This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .

Eligibility criteria: Inclusion Criteria:

* 20-50 years old pregnant woman
* ASAII-III
* Patients accepting spinal anesthesia

Exclusion Criteria:

* Morbid obesity(BMI \>40)
* Patients who are switched to general anesthesia in an unexpected perioperative situation
* Patients with placental anomaly
* Patients with bupivacaine allergy
* Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia

Primary outcomes:
measure: time of first analgesic need
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: visuel analog scale
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Basaksehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Akyol, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.
citation: Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.