Effect of Local Anesthetic Dose on Interscalene Block
Low Dose ISB
1 other identifier
interventional
154
1 country
1
Brief Summary
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
October 4, 2017
CompletedOctober 4, 2017
October 1, 2017
1 year
September 24, 2012
April 3, 2017
October 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Handgrip Strength
The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.
Difference between between baseline and postoperative.
Secondary Outcomes (3)
Patient Readiness to Discharge
Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
Duration of Analgesia
Postoperative Day 2
Side Effects
Postoperative Day 2
Study Arms (2)
Low Dose (20 mL) Local Anesthetic
EXPERIMENTALIntervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.
Control Dose (40 mL) Local Anesthetic
ACTIVE COMPARATORIntervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine
Interventions
Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
Eligibility Criteria
You may qualify if:
- Age: 18 - 80 years old
- Surgical time \< 2.5 hours
- ASA I, II or III
- Shoulder arthroscopy
You may not qualify if:
- Age \< 18 or \> 80 years old
- Chronic pain patients (on narcotics/opioids \> 3 months)
- Open shoulder surgical procedure
- BMI \> 40
- Pre-existing neurological condition
- Patient refusal of interscalene block
- Severe respiratory disease or hemidiaphragmatic dysfunction
- Allergy to any local anesthetics
- Planned general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Maalouf
- Organization
- HSS
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2012
First Posted
October 4, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 4, 2017
Results First Posted
October 4, 2017
Record last verified: 2017-10