Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in Laparoscopic Gynecological Surgery

NCT ID: NCT06017401

Last Updated: 2024-03-06

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-02-29

Brief Summary

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Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).

Detailed Description

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Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery, American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB group and TQL block will be performed for TQLB group. Patients will be administered postoperative 4x500 mg iv paracetamol as needed (if Visual Analogue Scale (VAS) score is 4 or higher). If the VAS score remains at 4 or higher 30 minutes after paracetamol administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption within the first 24 hours after surgery. The secondary outcome is to compare the time to the first postoperative analgesic requirement, VAS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale

Conditions

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Postoperative Pain Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group OSTAP

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Oblique Subcostal Transversus Abdominis Plane Block

Intervention Type PROCEDURE

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

Group TQLB

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Transmuscular Quadratus Lumborum Block

Intervention Type PROCEDURE

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Interventions

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Oblique Subcostal Transversus Abdominis Plane Block

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

Intervention Type PROCEDURE

Transmuscular Quadratus Lumborum Block

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ages of 18-65
* Patients who will undergo laparoscopic gynecological surgery
* ASA I-II-III patients
* Body Mass Index (BMI) in the range of 18-25 kg/m²
* Patients who will undergo surgery using 3 or 4 trocars

Exclusion Criteria

* ASA IV-V
* Patients with a known or suspected allergy to local anesthetics
* Coagulopathy
* Injection site infection
* Severe neurological or psychiatric disorders
* Severe cardiovascular disease
* Liver failure
* Kidney failure (glomerular filtration rate \<15 ml/min/m²)
* Chronic opioid use (\>6 months)
* Surgical durations less than 45 minutes or greater than 120 minutes
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Kübra Cebeci

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa Uludag University Faculty of Medicine

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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UludagU-KCebeci-001

Identifier Type: -

Identifier Source: org_study_id

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