Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Opioid Use
  • Pain Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

This study has been designed as a prospective, randomized and single-blind trial. Local ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After obtaining the patients' written informed consents, we will include a total number of 94 patients (47 patients for each...

This study has been designed as a prospective, randomized and single-blind trial. Local ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After obtaining the patients' written informed consents, we will include a total number of 94 patients (47 patients for each group). The inclusion criteria of the study was considered as age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for regional anesthesia, and unilateral shoulder surgery. The patients who have clotting disorder, contra-indication for regional anesthesia, infection on the injection site, chronic opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A computer-generated randomization program will be used to allocate the patient into two groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes will be blinded to the study groups of the patients. Both ISB block and cervical ESP block will be performed under ultrasound guidance in the block room preoperatively.

Tracking Information

NCT #
NCT04435236
Collaborators
Not Provided
Investigators
Principal Investigator: ?lker ?nce, MD Ataturk University Anesthesiology Clinical Research Office