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

Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017401
• Other study ID #: UludagU-KCebeci-001
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 29, 2024
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Surgery

Intervention

Procedure:
• Oblique Subcostal Transversus Abdominis Plane Block
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
• Transmuscular Quadratus Lumborum Block
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Locations

Country	Name	City	State
Turkey	Bursa Uludag University Faculty of Medicine	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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