Rotator Cuff InjuryPhase 4NCT02939209
Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
A Phase 4 study testing Hydromorphone Hcl 2Mg Tab in people with Rotator Cuff Injury and Pain, run by Vishal Uppal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injury, Pain
- What is being tested?
- Hydromorphone Hcl 2Mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Apr 2017to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site
Halifax, Nova Scotia, B3H1V8
St Joseph's (McMaster University)
Hamilton, Ontario, L8S4K1
About this study
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
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
- Being tested
- Hydromorphone Hcl 2Mg Tab, Placebo
- Keywords
- Rotator cuff repair, Interscalene block, Hydromorphone, Pain, Rebound pain, Acromioplasty
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone Hcl 2Mg TabDrug
Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
PlaceboDrug
Patients may be randomized to placebo.
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | Patients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit. Receives: Drug: Hydromorphone Hcl 2Mg Tab |
| Placebo | Placebo comparator | Patients will be given placebo in the post anesthetic care unit. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post interscalene block
Secondary outcomes (7)
Time to first rescue opioid use, within 24 hours after ISB insertion
Measured: 24 hours post interscalene block
Total rescue hydromorphone consumption, within 24 hours after ISB insertion
Measured: 24 hours post interscalene block
Two hourly pain score (burden of pain) while the patient is awake
Measured: 24 hours post interscalene block
Incidence of clinically significant nausea and vomiting after the dose of study drug
Measured: 24 hours post interscalene block
Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation
Measured: 24 hours post interscalene block
Number of patients needing emergency room visit due to pain within 24 hours of surgery
Measured: 24 hours post interscalene block
Number of patients needing hospital readmission due to pain within 24 hours of surgery
Measured: 24 hours post interscalene block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start20 Apr 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vishal Uppal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vishal Uppal, Nova Scotia Health Authority
- Investigators
- Vishal Uppal, Principal investigator, Dalhousie Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939209
- Sponsor's protocol ID
- 1021783
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2016
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37833472
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02939209
- Acronym / sponsor ID
- 1021783
- Conditions
- Rotator Cuff Injury, Pain
- Keywords
- Rotator cuff repair, Interscalene block, Hydromorphone, Pain, Rebound pain, Acromioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Vishal UppalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Experimental | Drug: Hydromorphone Hcl 2Mg TabPatients will be given 2 mg hydromorphone (immediate release) in the post anesthetic care unit. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be given placebo in the post anesthetic care unit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone Hcl 2Mg TabPatients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit. | Drug | Hydromorphone |
| PlaceboPatients may be randomized to placebo. | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 37833472Uppal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Uppal principal investigator
Dalhousie Anesthesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone Hcl 2Mg Tab in people with Rotator Cuff Injury and Pain, run by Vishal Uppal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst pain score (time frame: 24 hours post interscalene block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.