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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05758233
• Other study ID #: 2022-74
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Patients undergoing transversalis fascia plane block
The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
• Patients undergoing transversus abdominis plane block
The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.

Locations

Country	Name	City	State
Turkey	Basaksehir Çam and Sakura City Hospital	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of first analgesic need	Our primary goal was to meet the initial analgesic requirement times.	24 hours postoperatively
Secondary	visuel analog scale	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.	24 hours postoperatively