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Completed

NCT Number: NCT06017401

Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in 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).

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University Faculty of Medicine

Bursa, 16059, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oblique subcostal transversus abdominis plane block

Procedure

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

Transmuscular quadratus lumborum block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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