Methadone and Hydromorphone For Spinal Surgery

NCT02107339 | Completed Phase 4 Results

• 1 other identifier: EH14-113
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Pain complicates the recovery process, despite the routine practice of using potent opioid analgesics. The primary reason that pain is poorly controlled in patients undergoing major surgery is that most commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these drugs results in periods of time when a patient will experience discomfort (at which time a nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is pressed to deliver more medication). The use of a long-acting opioid may be advantageous in the perioperative setting. Methadone is an opioid that has a median duration of analgesia of 24-36 hours. Therefore, a single dose administered in the operating room may reduce the need for pain medication and improve pain control for the first few postoperative days. The aim of this randomized clinical trial is to examine the effect of methadone (compared to hydromorphone) on postoperative pain management in patients undergoing major spine surgery

Conditions

Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain

Keywords

methadone; hydromorphone; acute postoperative pain; chronic persistent surgical pain

Outcome Measures

Primary Outcomes (1)

• Hydromorphone Use at 24 Hours

  Use of hydromorphone at 24 hours

Secondary Outcomes (15)

• Hydromorphone Use Second 24 Hours

  24-48 hours after surgery

• Hydromorphone Use Third 24 Hours

  48-72 hours after surgery

• Pain Scores Postanesthesia Care Unit (PACU) Arrival

  First 5 minutes after PACU arrival

• Pain Scores 1 Hour After PACU Arrival

  Pain scores at 60 minutes after PACU admission

• Pain Scores 2 Hours After PACU Arrival

  Pain scores at 120 minutes after PACU admission

Study Arms (2)

methadone group

EXPERIMENTAL

Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)

Drug: Methadone

Hydromorphone group

ACTIVE COMPARATOR

Patients will receive hydromorphone 2 mg at the end of the surgical procedure

Drug: Hydromorphone

Interventions

Methadone DRUG

Methadone 0.2 mg/kg administered at induction of anesthesia

methadone group

Hydromorphone DRUG

Hydromorphone 2 mg administered at the conclusion of anesthesia

Hydromorphone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment.

You may not qualify if:

• Preoperative renal failure (defined as a serum creatinine \> 2.0 mg/dL.)
• American Society of Anesthesiologists Physical Status IV or V
• Pulmonary disease necessitating home oxygen therapy
• Allergy to methadone or hydromorphone
• Preoperative recent history of opioid or alcohol abuse
• Inability to use a PCA device or speak the English language

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction

Interventions

Methadone; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Glenn Murphy
• Organization: NorthShore University HealthSystem

dgmurphy2@yahoo.com

847-570-2760

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 30, 2019
• Results First Posted: August 16, 2016

Record last verified: 2019-09

Locations

US (1)