Pain, Postoperative Clinical Trial
Official title:
Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial
Verified date | April 2019 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.
Status | Completed |
Enrollment | 198 |
Est. completion date | October 13, 2018 |
Est. primary completion date | April 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery - Including rotator cuff repair - Stabilization procedures - Acromioplasty - Debridement and distal clavicle excision Exclusion Criteria: - Patient refusal - Diabetes - Pregnancy - Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist - Sensitivity to local anesthetics, dexamethasone or dexmedetomidine - Severe chronic obstructive pulmonary disease - Contralateral vocal cord paralysis - Contralateral diaphragmatic paralysis - Surgical limb brachial plexus neuropathy - Interscalene block site infection - Systemic glucocorticoids in the last 2 weeks - Epidural or intraarticular steroid injection in the past 3 months - Chronic opioid use defined as daily use for the last two weeks - Active peptic ulcer disease - End-stage renal disease - Cirrhotic liver disease - Ventricular dysfunction - Advanced heart block - Previous participation in the study. |
Country | Name | City | State |
---|---|---|---|
Canada | Pan Am Surgical Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intraoperative and post anesthesia care unit use of cardiovascular medications, as recorded in the patient's chart | The use of Intraoperative vasopressors, inotropes, antimuscarinics or antihypertensives at any time between the performance of the block and discharge from the post anesthesia care unit | Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block | |
Other | Adverse events previously related to the inter scalene block and unlikely related to dexamethasone or dexmedetomidine, as recorded in the patient's chart. | The occurrence of seizure, systemic local anesthetic toxicity, pneumothorax, hemothorax, epidural spread of local anesthetic, or hoarse voice at any time between the performance of the block and discharge from the post anesthesia care unit. | Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after the performance of the block | |
Primary | Duration of analgesia after ISB | Time from block performance to the first time shoulder pain was experienced after the surgery, rounded to the nearest 0.1 hours, as reported by the participant at telephone follow-up on postoperative day one, or if necessary, postoperative day 2. | Time-to-event outcome measure, assessed up to the end of postoperative day 3 (approximately 84 hours from performance of the block | |
Secondary | Block Success or Failure | The block will be considered "failed" if the patient required opioid analgesia for surgical site pain during their stay in the post anesthesia care unit, as determined by the patient's nurse. At our facility, patients are discharged home directly from the post anesthesia care unit. | Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block. | |
Secondary | Cumulative Analgesic Consumption in the post anesthesia care unit | Measured as equivalent milligrams of morphine | "Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 2.5 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 4 hours after performance of the block) | |
Secondary | Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred | Measured as equivalent milligrams of morphine | "Change" outcome measure: From discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block), to the occurrence of the primary outcome (an expected average of 28 hours after performance of the block) | |
Secondary | Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review | Transfer or admission to hospital during the postoperative period between admission to the post anesthesia care unit and telephone follow up on postoperative day one | Assessed at telephone follow up on postoperative day one and chart review | |
Secondary | New Persistent Neurologic Symptoms | Patient will be asked whether they are experiencing any tingling, numbness or weakness in the surgical limb, or hoarseness or dyspnea. Patients answering yes to any of the above will have a detailed telephone assessment and be reassessed by telephone at 6 months postoperatively | Assessed at postoperative day 14 | |
Secondary | Post anesthesia care unit length of stay in minutes | Amount of time between admission and discharge from the post anesthesia care unit. | Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after performance of the block. | |
Secondary | The QoR-15 questionnaire | A standardized and validated 15 item questionnaire consisting exclusively of 11 point integer scale questions (10 = all the time, 0 = none of the time) designed to assess quality of recovery, physical and mental wellbeing in patients recovering from surgery. A total composite score is measured as the total of all 15 individual scores. | Assessed at postoperative day one. |
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