The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05758233
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 25.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Sexual; Analgesia	Procedure: Transversalis Fascia Plane Block, Transversus Abdominis Plane Block	N/A

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 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomize studyProspective randomize study
• Masking: None (Open Label)
• Masking Description: prospective randomize study
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Jan 4, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Grup 1: Transversalis Fascia Plane Block (TFPB) Transversalis Fascia Plane Block (TFPB)	Procedure: Transversalis Fascia Plane Block, Transversus Abdominis Plane Block; Group 1: Transversalis Fascia Plane Block Group 2: Transversus Abdominis Plane Block
Experimental: Grup 2: Transversus Abdominis Plane Block (TAPB) Transversus Abdominis Plane Block (TAPB)	Procedure: Transversalis Fascia Plane Block, Transversus Abdominis Plane Block; Group 1: Transversalis Fascia Plane Block Group 2: Transversus Abdominis Plane Block

Outcome Measures

Primary Outcome Measures

1. time of first analgesic need [24 hours postoperatively]

   Our primary goal was to meet the initial analgesic requirement times.

Secondary Outcome Measures

1. visuel analog scale [24 hours postoperatively]

   Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Başakşehir Çam and Sakura City Hospital	Istanbul	Basaksehir	Turkey	3268

Sponsors and Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: Duygu Akyol, M.D, Basaksehir Cam & Sakura Şehir Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Duygu Akyol, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT05758233
• Other Study ID Numbers: 2022-74
• First Posted: Mar 7, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duygu Akyol, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital: anesthesia recovery period; cesarean section; obstetric anesthesia; spinal anaesthesia; postoperative analgesia
• Additional relevant MeSH terms: Agnosia

Study Results

No Results Posted as of Mar 10, 2023