Comparison of the Quality of Recovery After Cesarean Section Surgery

NCT ID: NCT05999981

Last Updated: 2023-11-13

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-24

Study Completion Date

2023-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Recovery Abdominal Pain Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transversalis Fascia Plane Block (TFPB) Group

At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.

Group Type ACTIVE_COMPARATOR

Transversalis Fascia Plane Block

Intervention Type PROCEDURE

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally

Transversus Abdominis Plane (TAP) Block Group

At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.

Group Type ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type PROCEDURE

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally

Interventions

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Transversalis Fascia Plane Block

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally

Intervention Type PROCEDURE

Transversus Abdominis Plane Block

40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Melike Korkmaz Toker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melike Korkmaz Toker, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

Locations

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Mugla Sıtkı Kocman University Training and Research Hospital

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29759061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32412986 (View on PubMed)

Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.

Reference Type DERIVED
PMID: 39039833 (View on PubMed)

Other Identifiers

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MSKU 13-IV

Identifier Type: -

Identifier Source: org_study_id

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