search
Back to results

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

Primary Purpose

Postoperative Pain, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oblique Subcostal Transversus Abdominis Plane Block
Transmuscular Quadratus Lumborum Block
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Postoperative pain, Pain management, Oblique subcostal transversus abdominis plane block, Transmuscular quadratus lumborum block, Quality of Recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bursa Uludag University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group OSTAP

Group TQLB

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative 24 hours total analgesic consumption
The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.

Secondary Outcome Measures

The time to the first analgesic requirement, NRS scores and QOR-15 scores of the patients
The secondary outcome is to compare the time to the first postoperative analgesic requirement, NRS 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 numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is 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.

Full Information

First Posted
August 20, 2023
Last Updated
September 16, 2023
Sponsor
Uludag University
search

1. Study Identification

Unique Protocol Identification Number
NCT06017401
Brief Title
Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in Laparoscopic Gynecological Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
December 18, 2023 (Anticipated)
Study Completion Date
February 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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 Numerical rating scale (NRS) score is 4 or higher). If the NRS 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, NRS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Surgery
Keywords
Postoperative pain, Pain management, Oblique subcostal transversus abdominis plane block, Transmuscular quadratus lumborum block, Quality of Recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group OSTAP
Arm Type
Active Comparator
Arm Description
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Arm Title
Group TQLB
Arm Type
Active Comparator
Arm Description
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Oblique Subcostal Transversus Abdominis Plane Block
Intervention Description
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Transmuscular Quadratus Lumborum Block
Intervention Description
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
Primary Outcome Measure Information:
Title
Postoperative 24 hours total analgesic consumption
Description
The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
The time to the first analgesic requirement, NRS scores and QOR-15 scores of the patients
Description
The secondary outcome is to compare the time to the first postoperative analgesic requirement, NRS 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 numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is 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.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bursa Uludag University Faculty of Medicine
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kübra CEBECI
Phone
+905532813646
Email
kubracebeci@uludag.edu.tr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs