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

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Surgery
• Intervention / Treatment: Procedure: Oblique Subcostal Transversus Abdominis Plane Block; Procedure: Transmuscular Quadratus Lumborum Block

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16059
    • Bursa Uludag University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain management; Quality of Recovery; Postoperative pain; Transmuscular quadratus lumborum block; Oblique subcostal transversus abdominis plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: UludagU-KCebeci-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No