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

NCT02939209 | Completed Phase 4

• 1 other identifier: 1021783
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Injury; Pain

Keywords

Rotator cuff repair; Interscalene block; Hydromorphone; Pain; Rebound pain; Acromioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Hydromorphone

EXPERIMENTAL

Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit.

Drug: Hydromorphone Hcl 2Mg Tab

Placebo

PLACEBO COMPARATOR

Patients will be given placebo in the post anesthetic care unit.

Drug: Placebo

Interventions

Hydromorphone Hcl 2Mg Tab DRUG

Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.

Hydromorphone

Placebo DRUG

Patients may be randomized to placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vishal Uppal: lead

Study Sites (2)

Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site

Halifax, Nova Scotia, B3H1V8, Canada

Location

St Joseph's (McMaster University)

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (1)

• 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.

  PMID: 37833472 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Vishal Uppal

  Dalhousie Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor & Staff Anesthesiologist

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 19, 2016
• Study Start: April 20, 2017
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

CA (2)