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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Rotator Cuff Injury
• Intervention / Treatment: Drug: Hydromorphone Hcl 2Mg Tab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H1V8
      • Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site
  • Ontario
    • Hamilton, Ontario, Canada, L8S4K1
      • St Joseph's (McMaster University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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	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

Collaborators and Investigators

• Sponsor: Vishal Uppal
• Investigators: Principal Investigator: Vishal Uppal, Dalhousie Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Hydromorphone; Rotator cuff repair; Interscalene block; Rebound pain; Acromioplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: 1021783

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No