Recruiting

Interscalene Block

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT00731146

Conditions

Arthroscopic Shoulder Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound Minimum Effective Anesthetic Volume

Nerve Stimulator Minimum Effective Anesthetic Volume

Study Details

Brief summary:

Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will be randomly assigned to a group to undergo ISBPB under ultrasound or nerve stimulator guidance. Each group will initially receive 10mL of local anesthetic. The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 2.5mL, while a success will cause the volume to decrease by the same amount. We hypothesize that the minimum effective anesthetic volume in 50% of patients will be significantly lower in the ultrasound guided group than in the nerve stimulator group. We further hypothesize that this lower volume will lead to a decreased rate of complications.

Conditions

Arthroscopic Shoulder Surgery

Study ID

NCT00731146

Start date

Aug, 2008

Status verified date

Aug, 2008

Completion date

Jul, 2009

Anticipated

Primary completion date

Feb, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients receiving interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria:

  • ASA >III, and body mass index (BMI) >35, pre-existing chronic obstructive pulmonary disease (COPD), unstable asthma, psychiatric history, renal or hepatic impairment, allergy to ropivacaine, and opioid tolerance (>30 mg oral morphine or equivalent per day).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1 - Ultrasound

Participants will receive an ultrasound guided interscalene brachial plexus block

active comparator: 2 - Nerve Stimulator

Participants will receive a nerve stimulator guided interscalene brachial plexus block

Interventions

Ultrasound Minimum Effective Anesthetic Volume

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

Nerve Stimulator Minimum Effective Anesthetic Volume

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

Primary outcome measure

  • Pain Rating as based on 11 point NRS scale [ Time Frame: within 30 minutes or less post-surgery ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Colin J McCartney, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 8, 2008

Last verified

Aug, 2008

Keywords

  • Interscalene Brachial Plexus Block
  • Regional Anesthesia
  • Ultrasound guided peripheral nerve block
  • Minimum Effective Anesthetic Volume
  • Nerve Stimulator guided peripheral nerve block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2008-08-08.