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

March 4, 2024 updated by: Kübra Cebeci, Uludag University

Comparison of The Effect of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Analgesia and Quality of Recovery in Patients Undergoing Laparoscopic Gynecological Surgery

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16059
        • Bursa Uludag University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group OSTAP
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Procedure: Oblique Subcostal Transversus Abdominis Plane Block
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Active Comparator: Group TQLB
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
Procedure: Transmuscular Quadratus Lumborum Block
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative 24 hours total analgesic consumption
Time Frame: 24 hours postoperatively
The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.
24 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients
Time Frame: 24 hours postoperatively

The secondary outcomes are to compare the time to the first postoperative analgesic requirement, VAS scores at 0, 30th min and 1, 2, 6, 12, 18, 24th hours at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QoR-15 scale.

A visual analogue scale (VAS) requires the patient to rate their pain on a scale of 0-10, where 0 represents no pain and 10 represents the worst pain imaginable.

The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UludagU-KCebeci-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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