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

Vishal Uppal

Status and phase

Completed

Phase 4

Conditions

Rotator Cuff Injury

Pain

Treatments

Drug: Placebo

Drug: Hydromorphone Hcl 2Mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT02939209

1021783

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.