NCT04947007

Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

Completed NA Last updated 2 March 2022

What this trial tests

NA trial testing Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection in Pain, Postoperative in 132 participants. Completed in 1 March 2022.

Timeline

15 July 2021

Primary endpoint
21 February 2022

1 March 2022

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	132
Start date	15 July 2021
Primary completion	21 February 2022
Estimated completion	1 March 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection — full drug profile →
• Bupivacaine HCl 0.025 % in 10+10 ML Injection — full drug profile →
• Bupivacaine HCl 0.025 % in 5+5 ML Injection — full drug profile →
• Isotonic solution

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Istanbul University

Who can join

Adults 18 to 80, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.