Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: Quadratus Lumborum Block III; Procedure: Quadratus Lumborum Block II; Procedure: Paravertebral Block; Drug: Patient controlled intravenous analgesia

• Registration Number: NCT05943015
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.

Detailed Description

Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.

The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.

Study Timeline

• Study Start: 2022-09-05
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• 18-65 years, American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria

• local anesthetic allergy
• Infection at the procedure site
• Body Mass Index >35 kg/m2
• Anticoagulant use with bleeding disorder
• Chronic analgesia and opioid use
• with mental and psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum Block III	Quadratus Lumborum Block III	Quadratus Lumborum Block III
Quadratus Lumborum Block III	Patient controlled intravenous analgesia	Quadratus Lumborum Block III
Paravertebral Block	Patient controlled intravenous analgesia	Paravertebral Block
Quadratus Lumborum Block II	Quadratus Lumborum Block II	Quadratus Lumborum Block II
Paravertebral Block	Paravertebral Block	Paravertebral Block
Quadratus Lumborum Block II	Patient controlled intravenous analgesia	Quadratus Lumborum Block II

Primary Outcome Measures

Name	Time	Method
Total amount of tramadol use	within 24 hours after the surgery	The total tramadol use of the patients in 24 hours will be recorded.

Secondary Outcome Measures

Name	Time	Method
postoperative length of hospital stay	within 1 weeks after the surgery	time to patient's discharge
Block onset time	30 min after the block	In order to evaluate sensory block, dermatome involvement will be evaluated with ice between Thoracic 1 and Lumbar 5 levels. When the feeling of coldness disappears, dermatome involvement will be considered. The sensory block formation time with ice will be evaluated as the block onset time, the10th, 20th and 30th minute dermatome area involvement will be recorded.
intraoperative remifentanil consumption	during operation procedure	The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
Visual Analogue Scale values at 1st, 6th, 12th and 24th hours	at 1st, 6th, 12th and 24th hours after the surgery	Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
side effects such as nausea, vomiting and shoulder pain	within 24 hours after the surgery	The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.

Trial Locations

Locations (1)

Gaziosmanpasa Resarch and Education Hospital; 🇹🇷 Istanbul, Turkey