Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
Study Overview
Brief Summary
Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.
Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block
Detailed Description
patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA I or II undergoing shoulder surgery under GA
Exclusion Criteria
- Not provided
Arms & Interventions
Slow administration group
They will receive 10 ml of 0.5% bupivacaine over 10 minutes
Intervention: Diaphragmatic excursion evaluation (Device)
Single shot
They will receive a 10 ml of 0.5 % bupivacaine as a single shot
Intervention: Diaphragmatic excursion evaluation (Device)
Outcomes
Primary Outcomes
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
Time Frame: baseline and 30 minutes after the block
defined as \> 75% reduction in diaphragmatic excursion
Secondary Outcomes
- partial phrenic block(baseline and 30 minutes after the block)
Investigators
Mina Adolf Helmy
Lecturer of anesthesia, Cairo university
Cairo University