Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

Study Overview
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Brief Summary
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This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.

Detailed Description
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This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.

Official Title
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A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Ropivacaine 0.75%
* Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine
* Drug: Ropivacaine 0.75% + 75 mcg clonidine
* Drug: Ropivacaine 0.75% + 8 mg dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have or are: Orthopedics service patients having shoulder surgery ASA(American Society of Anesthesiologists) class I, II, or III. Patients at least 18 years old but less than 71 years old. Patients giving informed consent. Non-Emergency Surgery Exclusion Criteria: Patients who have or are: An inability to cooperate during the block placement. Neuropathy of the planned extremity to block Diabetes Documented Kidney Disease Documented Liver Disease A lack of or inability to give informed consent. Currently incarcerated. Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Ropivacaine<br>Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively | Drug: Ropivacaine 0.75%<br>* Only ropivacaine 0.75% is administered for this arm of the interscalene block<br>* Other names: Naropin;|
| Experimental: Ropivacaine + Buprenorphine<br>A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively | Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine<br>* Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block<br>* Other names: Naropin + Buprenex;|
| Experimental: Ropivacaine + Clonidine<br>A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively | Drug: Ropivacaine 0.75% + 75 mcg clonidine<br>* Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block<br>* Other names: Naropin + Duraclon;|
| Experimental: Ropivaciane + Dexamethasone<br>A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively | Drug: Ropivacaine 0.75% + 8 mg dexamethasone<br>* Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block<br>* Other names: Naropin + Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia | Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off | 1-3 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block Set up Time | Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity | Day one | 
| Sensory Duration of Block | Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off | Day 1-3 | 
| Patient Reporting Vomiting at Home | Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. | 1-3 days | 
| Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at | Post-op Day 0 (Baseline) | 
| Number of Patients Reporting Nausea at Home | Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. | 1-3 days | 
| Number of Patients Reporting Nausea in the PACU | PACU (Post-Anesthesia Care Unit) assessment of nausea | Post-op day 0 (Baseline) | 
| Motor Duration of Block | Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off | Day 1-3 | 
| Number of Patients With Blood Pressure (BP) Changes in the PACU | Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at | Post-op Day 0 (baseline) | 
| Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | Blood pressure changes in Second Stage Recovery Area for patients was looked at | Post-op Day 0 (baseline) | 
| Pain Score Reported by Patients at First Phone Call | Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain. | Day 1-3 | 
| Number of Patients Reporting Itching in the PACU | Patients itching was assessed post-op in the PACU. | Post-op day 0 (baseline) | 
| Number of Patients Reporting Itching at Home | Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded. | 1-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachial Plexus Block, Clonidine, Dexamethasone, Buprenorphine