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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone | Experimental | Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit. |
|
| Placebo | Placebo Comparator | Patients will be given placebo in the post anesthetic care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone Hcl 2Mg Tab | Drug | Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst pain score | 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. | 24 hours post interscalene block |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue opioid use, within 24 hours after ISB insertion | 24 hours post interscalene block | |
| Total rescue hydromorphone consumption, within 24 hours after ISB insertion | 24 hours post interscalene block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishal Uppal | Dalhousie Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site | Halifax | Nova Scotia | B3H1V8 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37833472 | Derived | Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13. |
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| Placebo | Drug | Patients may be randomized to placebo. |
|
| Two hourly pain score (burden of pain) while the patient is awake | 24 hours post interscalene block |
| Incidence of clinically significant nausea and vomiting after the dose of study drug | 24 hours post interscalene block |
| Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation | 24 hours post interscalene block |
| Number of patients needing emergency room visit due to pain within 24 hours of surgery | 24 hours post interscalene block |
| Number of patients needing hospital readmission due to pain within 24 hours of surgery | 24 hours post interscalene block |
| St Joseph's (McMaster University) |
| Hamilton |
| Ontario |
| L8S4K1 |
| Canada |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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