Methadone and Interscalene Block for Shoulder Surgery
Status unconfirmed · Phase 4
Conditions studied: Pain
In brief
Patients undergoing shoulder surgery may experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Two methods are used to control pain in the early postoperative period. First, an interscalene nerve block (ISB) can be placed prior to surgery to block the pain fibers that supply the shoulder. Although an ISB provides effective analgesia for several hours after surgery, the block is associated with the potential for transient or permanent nerve injury. Furthermore, the ISB can wear off suddenly, resulting in the abrupt onset of severe pain. A second method of pain control involves the use of opioids. Opioids can provide potent pain relief following surgical procedures. However, the agents that are commonly used by anesthesiologists and surgeons only produce pain relief for 2-4 hours, which leads to fluctuations in the levels of pain control. Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after surgery. The aim of this clinical trial is to compare postoperative pain scores and analgesic requirements in patients randomized to receive either an ISB or methadone at the start of shoulder arthroscopic surgery.
Key facts
- Study ID
- NCT03084588
- Run by
- Endeavor Health
- People needed
- 100
- Starts
- 2016-07-01
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2020-08-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All patients presenting for elective shoulder arthroscopic procedures will be eligible for enrollment.
You may not qualify if…
- Preoperative renal failure requiring dialysis
- Poorly controlled pulmonary disease (severe asthma or COPD) -Contraindication to regional anesthesia (recent anticoagulant use)
- Sleep apnea or morbid obesity with possible sleep apnea
- Allergy to methadone
- Significant preoperative pain requiring treatment with high doses of opioids (more than 6-8 Norco tablets or equivalence per day) or recent history of opioid abuse
Where it is running
- NorthShore University HealthSystem — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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