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CompletedNCT06017401Updated Mar 6, 2024

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

An interventional study of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block in Postoperative Pain and Surgery, sponsored by Uludag University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Uludag University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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).

Read the 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

02

Conditions studied

  • Postoperative Pain
  • Surgery

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Keywords

  • Postoperative pain
  • Pain management
  • Oblique subcostal transversus abdominis plane block
  • Transmuscular quadratus lumborum block
  • Quality of Recovery
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 68 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
68 participants (actual)

Study arms

  • 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

  • Active comparator
    Group TQLB

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

    Procedure: Transmuscular Quadratus Lumborum Block

Interventions

  • ProcedureOblique Subcostal Transversus Abdominis Plane Block

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

  • ProcedureTransmuscular Quadratus Lumborum Block

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients

    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.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Bursa Uludag University Faculty of Medicine
    Bursa, 16059, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06017401
Lead sponsor
Uludag University
Responsible party
Kübra Cebeci (Research Assistant, Uludag University) — Principal investigator
First posted
Aug 30, 2023
Start date
May 22, 2023
Primary completion
Nov 27, 2023
Completion
Feb 29, 2024
Last update
Mar 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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