Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
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|ClinicalTrials.gov Identifier: NCT02939209|
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : July 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Injury Pain||Drug: Hydromorphone Hcl 2Mg Tab Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
Patients may be randomized to placebo.
- Worst pain score [ Time Frame: 24 hours post interscalene block ]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 to first rescue opioid use, within 24 hours after ISB insertion [ Time Frame: 24 hours post interscalene block ]
- Total rescue hydromorphone consumption, within 24 hours after ISB insertion [ Time Frame: 24 hours post interscalene block ]
- Two hourly pain score (burden of pain) while the patient is awake [ Time Frame: 24 hours post interscalene block ]
- Incidence of clinically significant nausea and vomiting after the dose of study drug [ Time Frame: 24 hours post interscalene block ]
- Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation [ Time Frame: 24 hours post interscalene block ]
- Number of patients needing emergency room visit due to pain within 24 hours of surgery [ Time Frame: 24 hours post interscalene block ]
- Number of patients needing hospital readmission due to pain within 24 hours of surgery [ Time Frame: 24 hours post interscalene block ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939209
|Contact: Vera Lloyd||90247232220||Vera.Lloyd@nshealth.ca|
|Contact: Vishal Uppal, MD||90247232220||V.Uppal@dal.ca|
|Canada, Nova Scotia|
|Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site||Recruiting|
|Halifax, Nova Scotia, Canada, B3H1V8|
|Contact: Xue Chen (Janny) Ke, MD 9024732220 firstname.lastname@example.org|
|Contact: Vishal Uppal, MD 9024732220 V.email@example.com|
|Sub-Investigator: Xue Chen Ke, MD|
|Principal Investigator: Vishal Uppal, MD|
|Sub-Investigator: Kwesi Kwofie, MD|
|Sub-Investigator: Andrew Trenholm, MD|
|Sub-Investigator: Jimmy Nyugen, MD|
|Sub-Investigator: Harsha Shanthanna, MD|
|Principal Investigator:||Vishal Uppal||Dalhousie Anesthesia|