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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
Sponsor:
Information provided by (Responsible Party):
Vishal Uppal, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Injury Pain Drug: Hydromorphone Hcl 2Mg Tab Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to first rescue opioid use, within 24 hours after ISB insertion [ Time Frame: 24 hours post interscalene block ]
  2. Total rescue hydromorphone consumption, within 24 hours after ISB insertion [ Time Frame: 24 hours post interscalene block ]
  3. Two hourly pain score (burden of pain) while the patient is awake [ Time Frame: 24 hours post interscalene block ]
  4. Incidence of clinically significant nausea and vomiting after the dose of study drug [ Time Frame: 24 hours post interscalene block ]
  5. Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation [ Time Frame: 24 hours post interscalene block ]
  6. Number of patients needing emergency room visit due to pain within 24 hours of surgery [ Time Frame: 24 hours post interscalene block ]
  7. Number of patients needing hospital readmission due to pain within 24 hours of surgery [ Time Frame: 24 hours post interscalene block ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Vera Lloyd 90247232220 Vera.Lloyd@nshealth.ca
Contact: Vishal Uppal, MD 90247232220 V.Uppal@dal.ca

Locations
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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    jannyke@dal.ca   
Contact: Vishal Uppal, MD    9024732220    V.uppal@dal.ca   
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         
Sponsors and Collaborators
Vishal Uppal
Investigators
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Principal Investigator: Vishal Uppal Dalhousie Anesthesia

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Responsible Party: Vishal Uppal, Assistant Professor & Staff Anesthesiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02939209     History of Changes
Other Study ID Numbers: 1021783
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vishal Uppal, Nova Scotia Health Authority:
Rotator cuff repair
Interscalene block
Hydromorphone
Pain
Rebound pain
Acromioplasty

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Hydromorphone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents