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

NCT ID: NCT05758233

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2022-06-30

Brief Summary

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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

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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 .

Conditions

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Anesthesia; Sexual Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomize study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

prospective randomize study

Study Groups

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Grup 1: Transversalis Fascia Plane Block (TFPB)

Transversalis Fascia Plane Block (TFPB)

Group Type EXPERIMENTAL

Patients undergoing transversalis fascia plane block

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Grup 2: Transversus Abdominis Plane Block (TAPB)

Transversus Abdominis Plane Block (TAPB)

Group Type EXPERIMENTAL

Patients undergoing transversalis fascia plane block

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Duygu Akyol

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duygu Akyol, M.D

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

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Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35455750 (View on PubMed)

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.

Reference Type RESULT
PMID: 31653797 (View on PubMed)

Other Identifiers

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2022-74

Identifier Type: -

Identifier Source: org_study_id

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