Recruiting

Interscalene Block

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT01703130

Conditions

Shoulder Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dose of of ropivacaine 0.75% used in block procedure

Study Details

Brief summary:

Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder surgery. However, patients can experience complications such as blurred vision, hoarseness and shortness of breath with the standard volumes of local anesthetic used in contemporary practice. Patients with respiratory diseases are precluded because of the potential effects on respiration. However, they are then exposed to the risks of general anesthesia and opioid medications which can also have detrimental effects on respiration. Ultrasound guided ISB can reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this may reduce the complications from ISB to allow patients previously unable to benefit to have this technique, such as patients with obesity and respiratory disease. In order to do so the investigators will use an up-down methodology to find the minimum volume of local anesthetic to provide sufficient anesthesia for shoulder surgery.

Conditions

Shoulder Pain

Study ID

NCT01703130

Start date

Oct, 2012

Status verified date

May, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing elective arthroscopic shoulder surgery in the sitting position
  • Patients aged >=18 and <=75 years
  • ASA I-III

Exclusion Criteria:

  • Patient refusal for surgery under ISBPB with sedation
  • Lack of capacity to provide informed consent
  • Pre-existing COPD, unstable asthma or diaphragmatic dysfunction
  • Coagulopathy
  • Infection at injection site
  • Allergy to local anesthetics
  • Opioid tolerance (>30mg oral morphine or equivalent/day for >1 week)
  • BMI>40
  • Inability to complete questionnaires and assessments (consent, follow-up phone call) due to language barrier
  • Pregnancy or lactation

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Local Anesthestic Dose

Interventions

Dose of of ropivacaine 0.75% used in block procedure

Primary outcome measure

  • MEAV95 of ropivacaine 0.75% [ Time Frame: 30 minutes post injection ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre

Recruiting

Toronto, Ontario, Canada, M4Y 1H1

Principal Investigator:

Colin McCartney

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jun 2, 2014

Last verified

May, 2014

Keywords

  • ISPB
  • Brachial Plexus Block
  • Anesthesia
  • Pain Management
  • Surgery

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 2014-06-02.