Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia

Shoulder Pain Clinical Trial

— MEAV 95  

Official title:

Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01703130
• Other study ID #: 126-2012
• Status: Recruiting
• Phase: Phase 4
• First received: October 4, 2012
• Last updated: May 29, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: Colin McCartney
• Phone: (416) 480-6100
• Email: colin.mccartney[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Dose of of ropivacaine 0.75% used in block procedure

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEAV95 of ropivacaine 0.75%	to determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic	30 minutes post injection	No
Secondary	Motor blockade	The C5 myotome covers the deltoid muscle (the most powerful motion being shoulder abduction) and the biceps brachii muscle. Biceps brachii is also innervated by C6. Therefore, motor blockade will be assessed by testing shoulder abduction and forearm flexion. Motor function will be classified as present (any movement) or absent (no movement)	30 minutes	No
Secondary	Bedside spirometry	Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery	30 minutes post block, 30min post-surgery, and 2 hours post surgery	Yes
Secondary	Diaphragmatic excursion	Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery	30 minutes post block, and 2 hours post surgery	Yes
Secondary	Complications	Complications: Hoarseness, Horner's syndrome, intravascular injection	30 minutes	Yes
Secondary	Pain Scores on Visual Analog Scale	Visual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge	at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge	No
Secondary	Total opioid consumption until discharge	Total opioid consumption until discharge	24 hours (at discharge)	No
Secondary	Opioid related side effects	Opioid related side effects: nausea, vomiting, dizziness, pruritis	24 hours (at discharge)	No
Secondary	Time to first analgesic use	Time to first analgesic use in hospital and after discharge	within 24 hours post surgery	No

External Links

•   Facility website