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

Sponsor
Uludag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06017401
Collaborator
(none)
68
1
2
9.1
7.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Oblique Subcostal Transversus Abdominis Plane Block
  • Procedure: Transmuscular Quadratus Lumborum Block
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of The Efficacy 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
Actual Study Start Date :
May 18, 2023
Anticipated Primary Completion Date :
Dec 18, 2023
Anticipated Study Completion Date :
Feb 18, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Postoperative 24 hours total analgesic consumption [24 hours postoperatively]

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

Secondary Outcome Measures

  1. The time to the first analgesic requirement, NRS scores and QOR-15 scores of the patients [24 hours postoperatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Uludag University Faculty of Medicine Bursa Turkey 16059

Sponsors and Collaborators

  • Uludag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kübra Cebeci, Research Assistant, Uludag University
ClinicalTrials.gov Identifier:
NCT06017401
Other Study ID Numbers:
  • UludagU-KCebeci-001
First Posted:
Aug 30, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kübra Cebeci, Research Assistant, Uludag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023