Nerve Pain, Shoulder Pain
Conditions
Keywords
duration of analgesia
Brief summary
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.
Detailed description
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control. Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks. The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.
Interventions
DRUGDexmedetomidine
0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction
DRUGRopivacaine
15 ml 0.5%
DRUGNormal Saline
1 mL 0.9%
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* unilateral surgical shoulder procedures under general anesthetic * English speaking patients * ASA I-III patients * BMI \<38 kg/m2
Exclusion criteria
* proximal clavicular surgery * preexisting neurological deficits or peripheral neuropathy * known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias * known cerebrovascular disease * baseline heart rate \<60 beats per minute or baseline systolic blood pressure \<100 mm Hg * medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment * severe bronchopulmonary disease * local infection * contra-indication to regional anesthesia (bleeding, coagulopathy) * chronic pain disorders * current use of over 30mg oxycodone or equivalent per day * contraindication to a component of multimodal analgesia * allergy to local anesthetics or dexmedetomidine * history of significant psychiatric conditions that may affect patient assessment * pregnancy * inability to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of interscalene nerve block. | Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site. |
| Opioid consumption | Cumulative opioid consumption at 24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | Total use of opioids from the period of intra-operative to 2 weeks post-operative | The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed. |
Countries
Canada
Outcome results
None listed