Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Rotator Cuff Injury, Pain

Intervention / Treatment
-----------------
* Drug: Hydromorphone Hcl 2Mg Tab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 scheduled to receive ISB and general anesthesia as a day surgery patient for rotator cuff repair and acromioplasty, as a part of planned routine care Exclusion Criteria: Allergy, sensitivity, or absolute contraindications to any of the medications involved in the study preexisting CNS depression, or taking regularly medication that cause CNS depression preexisting cognitive deficits, dementia, or delirium severe respiratory comorbidities (e.g. chronic obstructive pulmonary disease, pneumonia, respiratory failure) sleep disordered breathing (diagnosed OSA, obesity hypoventilation syndrome) pregnancy and breast feeding history of chronic pain or regular (at least once daily) opioid use preoperatively renal impairment - CrCl ≤60 mL/minute not fluent in English to be able to participate in the study process, including consent and phone interview Body Mass Index >35 inability to take oral medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydromorphone<br>Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit. | Drug: Hydromorphone Hcl 2Mg Tab<br>* Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.<br>|
| Placebo Comparator: Placebo<br>Patients will be given placebo in the post anesthetic care unit. | Drug: Placebo<br>* Patients may be randomized to placebo.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotator cuff repair, Interscalene block, Hydromorphone, Pain, Rebound pain, Acromioplasty