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 : Completed
First Posted : December 31, 2015
Last Update Posted : July 10, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||April 2019|
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.
- Duration of analgesic block [ Time Frame: 48 hours ]Defined as time from end of injection to first sensation of pain at surgical site
- Time to first opioid consumption [ Time Frame: 24 hours or less ]Defined as time from end of injection to time to oral opioid consumption
- 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
- Diaphragmatic dysfunction assessed by ultrasound [ Time Frame: 4 hours ]Assessed at at 4 hours post block compared to pre-operative values
- Opioid consumption [ Time Frame: 24 and 48 hours ]Cumulative opioid consumption at 24 and 48 hours
- Pain VAS scores [ Time Frame: 4, 8, 12, 24, 48 hours ]Pain VAS scores at 4, 8, 12, 24, 48 hours (patient diary)
- Vital capacity [ Time Frame: 4 hours ]Assessed at at 4 hours post block compared to pre-operative values
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
|Holland Orthopedic and Arthritic Centre|
|Toronto, Ontario, Canada, M2N-3Y7|
|Principal Investigator:||Ben Safa, MD||Sunnybrook Health Sciences Center|