Methadone and Interscalene Block for Shoulder Surgery

NCT03084588 | Unknown Phase 4

• 1 other identifier: EH15-399
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

  scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

  at 24 hours

Secondary Outcomes (4)

• Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

  at 4 hours after PACU admission

• hydromorphone consumption

  1 hour after admission

• Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

  at 48 hours

• Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

  at 72 hours

Study Arms (2)

Methadone

ACTIVE COMPARATOR

Patients in the methadone group will receive a single dose of methadone 0.2 mg/kg at induction of anesthesia

Drug: methadone

Interscalene block

ACTIVE COMPARATOR

Patients in the intersclene block group will receive an interscalene block prior to induction of anesthesia

Procedure: Interscalene block

Interventions

methadone DRUG

Patients will be given methadone at induction of anesthesia

Methadone

Interscalene block PROCEDURE

Patients will be given an interscalene block prior to induction of anesthesia

Also known as: procedure

Interscalene block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Methadone; Methods

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: March 21, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)