Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939209
• Other study ID #: 1021783
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Rotator Cuff Injuries
• Rotator Cuff Injury

Intervention

Drug:
• Hydromorphone Hcl 2Mg Tab
Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
• Placebo
Patients may be randomized to placebo.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority Queen Elizabeth II Hospital Halifax Infirmary site	Halifax	Nova Scotia
Canada	St Joseph's (McMaster University)	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Vishal Uppal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours post interscalene block
Secondary	Time to first rescue opioid use, within 24 hours after ISB insertion		24 hours post interscalene block
Secondary	Total rescue hydromorphone consumption, within 24 hours after ISB insertion		24 hours post interscalene block
Secondary	Two hourly pain score (burden of pain) while the patient is awake		24 hours post interscalene block
Secondary	Incidence of clinically significant nausea and vomiting after the dose of study drug		24 hours post interscalene block
Secondary	Number of patients failing discharge from hospital due to pain, nausea, vomiting or sedation		24 hours post interscalene block
Secondary	Number of patients needing emergency room visit due to pain within 24 hours of surgery		24 hours post interscalene block
Secondary	Number of patients needing hospital readmission due to pain within 24 hours of surgery		24 hours post interscalene block