Clinical trial NCT02939209: Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotator Cuff Injury
Pain
Keywords: Rotator cuff repair
Interscalene block
Hydromorphone
Pain
Rebound pain
Acromioplasty
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Worst pain score
timeFrame: 24 hours post interscalene block
Secondary outcomes:
measure: Time to first rescue opioid use, within 24 hours after ISB insertion
timeFrame: 24 hours post interscalene block
measure: Total rescue hydromorphone consumption, within 24 hours after ISB insertion
timeFrame: 24 hours post interscalene block
measure: Two hourly pain score (burden of pain) while the patient is awake
timeFrame: 24 hours post interscalene block
measure: Incidence of clinically significant nausea and vomiting after the dose of study drug
timeFrame: 24 hours post interscalene block
measure: Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation
timeFrame: 24 hours post interscalene block
measure: Number of patients needing emergency room visit due to pain within 24 hours of surgery
timeFrame: 24 hours post interscalene block
measure: Number of patients needing hospital readmission due to pain within 24 hours of surgery
timeFrame: 24 hours post interscalene block
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site
state: Nova Scotia
city: Hamilton
country: Canada
facility: St Joseph's (McMaster University)
state: Ontario
Study officials:
affiliation: Dalhousie Anesthesia
name: Vishal Uppal
role: PRINCIPAL_INVESTIGATOR
References: