Hydromorphone Hcl 2Mg Tab
DrugPatients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
NCT Number: NCT02939209
Arthroscopic shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has regressed. This study will assess whether a single dose of oral hydromorphone controlled release, given to overlap the waning of the ISB, will improve postoperative pain control and reduce the incidence of rebound pain.
Seventy patients undergoing rotator cuff repair will receive standardized ISB and general anesthesia for the surgery. Six hours (+/- 1 hour) after ISB, the patients will randomly receive either a single oral dose of 2 mg Hydromorphone (immediate release formulation) or placebo. The patient will be then discharged home with a prescription for multimodal analgesia, which is the standard of care. Patients will be given a diary to record their pain scores and track use of analgesic medications for 24 hours. Twenty-four hours after the ISB, the patients will receive a phone call from a nurse as per the standard of care. During this phone call, questions will be asked about their pain control.
If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it will lead to change in practice of how we manage pain after rotator cuff repair. Furthermore, the finding of this study may apply to similar surgical procedures (such as elbow, knee and ankle repairs) that are associated with rebound pain when the nerve block wears off.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site, Halifax, Nova Scotia, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
Patients may be randomized to placebo.
Time frame: 24 hours post interscalene block
We will investigate whether a single dose of hydromorphone 2 mg, given at six hours after single-shot ISB for rotator cuff repair, reduces worst pain score (NRS) in first 24 hours by two points or more as measured on 11 point (0-10) NRS scale when compared to placebo, with perioperative multimodal analgesia used in both groups.
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Time frame: 24 hours post interscalene block
Vishal Uppal
Other
Preventing Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block: A Randomized Controlled Trial of Pre-emptive Opioid Treatment Compared to Placebo
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