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Analgesic Duration of Long Acting Local Anesthetics for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block

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ClinicalTrials.gov Identifier: NCT02643563
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ben Safa, Sunnybrook Health Sciences Centre

Brief Summary:

Severe pain following shoulder surgery is common and remains a major challenge. The interscalene nerve block is well suited for operations on the shoulder or upper arm, for providing surgical anesthesia as well as prolonged effective postoperative analgesia.

Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic. The current trend is to lower the volume of local anesthetic for ultrasound-guided interscalene block in order to reduce potential complications such as phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic duration of the block could be compromised. Studies to elucidate the best local anesthetic agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks, however, there are no studies comparing their analgesic duration in the setting of low volume interscalene block to date.

This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5% Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB.

This study aims to conduct a comparison of the duration of post operative analgesia achieved by these agents, hence allowing the appropriate local anesthetic agent and concentration selection in low-volume techniques.


Condition or disease Intervention/treatment Phase
Brachial Plexus Block Anesthetics, Local Drug: Ropivacaine 0.5% Drug: Ropivacaine 1% Drug: Bupivacaine 0.5% + epinephrine 1:200,000 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivicaine Versus 1 % Ropivicaine for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block
Study Start Date : January 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Ropivacaine 0.5%
Low volume (5 ml) Interscalene Block with Ropivacaine 0.5%
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% is used for low-volume ultrasound-guided interscalene brachial plexus block.

Active Comparator: Ropivacaine 1%
Low volume (5 ml) Interscalene Block with Ropivacaine 1%
Drug: Ropivacaine 1%
Ropivicaine 1% is used for low-volume ultrasound-guided interscalene brachial plexus block.

Active Comparator: Bupivacaine 0.5% + epinephrine 1:200,000
Low volume (5 ml) Interscalene Block with Bupivacaine 0.5% + epinephrine 1:200,000
Drug: Bupivacaine 0.5% + epinephrine 1:200,000
Bupivacaine 0.5% + epinephrine 1:200,000 is used for low-volume ultrasound-guided interscalene brachial plexus block.




Primary Outcome Measures :
  1. Duration of analgesic block [ Time Frame: 48 hours ]
    Defined as time from end of injection to first sensation of pain at surgical site


Secondary Outcome Measures :
  1. Time to first opioid consumption [ Time Frame: 24 hours or less ]
    Defined as time from end of injection to time to oral opioid consumption

  2. Duration of motor block [ Time Frame: 24 hours or less ]
    Defined as time from end of injection to time of preoperative biceps and hand strength

  3. Diaphragmatic dysfunction assessed by ultrasound [ Time Frame: 4 hours ]
    Assessed at at 4 hours post block compared to pre-operative values

  4. Opioid consumption [ Time Frame: 24 and 48 hours ]
    Cumulative opioid consumption at 24 and 48 hours

  5. Pain VAS scores [ Time Frame: 4, 8, 12, 24, 48 hours ]
    Pain VAS scores at 4, 8, 12, 24, 48 hours (patient diary)

  6. Vital capacity [ Time Frame: 4 hours ]
    Assessed at at 4 hours post block compared to pre-operative values



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre
  2. ASA functional status class I to III
  3. BMI < 35 kg/m2

Exclusion Criteria:

  1. Lack of patient consent
  2. Allergy to bupivacaine or ropivacaine
  3. BMI > 35 kg/m2
  4. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  5. Pregnant or nursing females
  6. Chronic opioid use defined as > 30mg oral morphine equivalent per day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643563


Contacts
Contact: Ben Safa, MD 416 480 4864 ben.safa@sunnybrook.ca
Contact: Stephen Choi, MD 416 480 4864 stephen.choi@sunnybrook.ca

Locations
Canada, Ontario
Holland Orthopedic and Arthritic Centre Recruiting
Toronto, Ontario, Canada, M2N-3Y7
Contact: Stephen JL Choi, MD, FRCPC    416 480 4864 ext 3230    Colin.McCartney@sunnybrook.ca   
Sub-Investigator: Colin JL McCartney, MD, FRCPC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Ben Safa, MD Sunnybrook Health Sciences Center

Responsible Party: Dr. Ben Safa, Anesthesiologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02643563     History of Changes
Other Study ID Numbers: 456-2014
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Dr. Ben Safa, Sunnybrook Health Sciences Centre:
Brachial Plexus Block
Anesthetics, Local

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents