Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Methadone and Interscalene Block for Shoulder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084588
Recruitment Status : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Glenn Murphy, NorthShore University HealthSystem

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.

Condition or disease Intervention/treatment Phase
Pain Drug: methadone Procedure: Interscalene block Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methadone and Interscalene Block for Shoulder Surgery
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Methadone
Patients in the methadone group will receive a single dose of methadone 0.2 mg/kg at induction of anesthesia
Drug: methadone
Patients will be given methadone at induction of anesthesia

Active Comparator: Interscalene block
Patients in the intersclene block group will receive an interscalene block prior to induction of anesthesia
Procedure: Interscalene block
Patients will be given an interscalene block prior to induction of anesthesia
Other Name: procedure




Primary Outcome Measures :
  1. Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable) [ Time Frame: at 24 hours ]
    scale of 0 to 10 (0=no pain, 10= worst pain imaginable)


Secondary Outcome Measures :
  1. Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable) [ Time Frame: at 4 hours after PACU admission ]
    scale of 0 to 10 (0=no pain, 10 = worst pain imaginable)

  2. hydromorphone consumption [ Time Frame: 1 hour after admission ]
    at PACU dischage

  3. Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable) [ Time Frame: at 48 hours ]
    scale of 0 to 10 (0=no pain, 10=worst pain imaginable)

  4. Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable) [ Time Frame: at 72 hours ]
    scale of 0 to 10 (0=no pain, 10=worst pain imaginable)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients presenting for elective shoulder arthroscopic procedures will be eligible for enrollment.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084588


Locations
Layout table for location information
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Layout table for additonal information
Responsible Party: Glenn Murphy, Director Clinical Research, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT03084588    
Other Study ID Numbers: EH15-399
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents