Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
Primary Purpose
Rotator Cuff Injury, Pain
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Hydromorphone Hcl 2Mg Tab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Rotator Cuff Injury focused on measuring Rotator cuff repair, Interscalene block, Hydromorphone, Pain, Rebound pain, Acromioplasty
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.
Sites / Locations
- Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site
- St Joseph's (McMaster University)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydromorphone
Placebo
Arm Description
Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit.
Patients will be given placebo in the post anesthetic care unit.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to first rescue opioid use, within 24 hours after ISB insertion
Total rescue hydromorphone consumption, within 24 hours after ISB insertion
Two hourly pain score (burden of pain) while the patient is awake
Incidence of clinically significant nausea and vomiting after the dose of study drug
Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation
Number of patients needing emergency room visit due to pain within 24 hours of surgery
Number of patients needing hospital readmission due to pain within 24 hours of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02939209
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vishal Uppal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury, Pain
Keywords
Rotator cuff repair, Interscalene block, Hydromorphone, Pain, Rebound pain, Acromioplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydromorphone
Arm Type
Experimental
Arm Description
Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be given placebo in the post anesthetic care unit.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone Hcl 2Mg Tab
Intervention Description
Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients may be randomized to placebo.
Primary Outcome Measure Information:
Title
Worst pain score
Description
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.
Time Frame
24 hours post interscalene block
Secondary Outcome Measure Information:
Title
Time to first rescue opioid use, within 24 hours after ISB insertion
Time Frame
24 hours post interscalene block
Title
Total rescue hydromorphone consumption, within 24 hours after ISB insertion
Time Frame
24 hours post interscalene block
Title
Two hourly pain score (burden of pain) while the patient is awake
Time Frame
24 hours post interscalene block
Title
Incidence of clinically significant nausea and vomiting after the dose of study drug
Time Frame
24 hours post interscalene block
Title
Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation
Time Frame
24 hours post interscalene block
Title
Number of patients needing emergency room visit due to pain within 24 hours of surgery
Time Frame
24 hours post interscalene block
Title
Number of patients needing hospital readmission due to pain within 24 hours of surgery
Time Frame
24 hours post interscalene block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishal Uppal
Organizational Affiliation
Dalhousie Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H1V8
Country
Canada
Facility Name
St Joseph's (McMaster University)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
We'll reach out to this number within 24 hrs