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

Not Applicable

Completed

• Conditions: Surgery; Postoperative Pain
• Interventions: Procedure: Oblique Subcostal Transversus Abdominis Plane Block; Procedure: Transmuscular Quadratus Lumborum Block

• Registration Number: NCT06017401
• Lead Sponsor: Uludag University

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 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 Timeline

• Study Start: 2023-05-22
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Primary Completion: 2023-11-27
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group OSTAP	Oblique Subcostal Transversus Abdominis Plane Block	The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Group TQLB	Transmuscular Quadratus Lumborum Block	The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Bursa Uludag University Faculty of Medicine; 🇹🇷 Bursa, Turkey