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Methadone and Hydromorphone For Spinal Surgery

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ClinicalTrials.gov Identifier: NCT02107339
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : August 16, 2016
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Glenn Murphy, NorthShore University HealthSystem

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

Condition or disease Intervention/treatment Phase
Hydromorphone Use Acute Postoperative Pain Patient Satisfaction Chronic Persistent Surgical Pain Drug: Methadone Drug: Hydromorphone Phase 4

Detailed Description:

Patients: 100 patients (ages 18-80) will be enrolled in this clinical trial. All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment. Patients will be randomized to receive either methadone or hydromorphone on the basis of a computer generated random number table. Patients in each group will receive standard clinical intraoperative doses of either methadone (0.2 mg/kg) or hydromorphone (2 mg). An analysis of patients undergoing posterior lumbar fusion surgery at Evanston Hospital revealed that patients received, on average, approximately 2 mg of hydromorphone intraoperatively. The most commonly used doses of methadone administered in clinical studies have been either 0.2 mg/kg or a dose of 20 mg. Furthermore, these doses also represent dosages which appear to be approximately equipotent. Study medications will be prepared by the pharmacy, and all clinicians will be blinded to group assignment. Two syringes will be prepared for each patient, one which contains the study drug (either methadone 0.2 mg/kg or hydromorphone 2 mg), and the other containing the placebo (saline). If the patient is randomized to the methadone group, a 3 cc syringe containing 0.2 mg/kg of methadone and saline (total volume 3 cc) will be prepared, as well as a 10 cc syringe containing 10 cc of saline (placebo). If the patient is randomized to the hydromorphone group, a 3 cc syringe containing 3 cc of saline (placebo) will be prepared, as well as a 10 cc syringe containing 2 mg of hydromorphone with 9 cc of saline (total volume 10 cc). At induction of anesthesia, the 3 cc syringe containing either 0.2 mg/kg of methadone or placebo will be given over 5 seconds. At the conclusion of surgery, the 10 cc syringe of either hydromorphone or placebo will be titrated slowly per clinician's preference. The administration of all other anesthetic agents will be standardized and reflect the usual practices of anesthesiologists at Evanston Hospital (spine protocol).

Anesthesia will be standardized and include propofol for induction, a propofol and remifentanil infusion for maintenance (plus sevoflurane), and IV acetaminophen 1000 mg during the last 60 minutes of the case.

On arrival to the postanesthesia care unit (PACU), patients will be assessed for pain by PACU nurses per standard protocols. Patients will be evaluated for pain on PACU arrival and then every 15 minutes. Patients will be administered hydromorphone 0.25-0.5 mg for pain, and doses will be repeated until the patient is comfortable (pain < 3 on a scale of 0-10; 0=no pain and 10=worst pain imaginable). The patient will then be connected to a PCA device to deliver pain medication during the remainder of the postoperative period.

All postoperative management will be per standard surgical protocols

Sample Size: The primary end-point of the investigation is amount of hydromorphone used. In a clinical trial by Urban et al. of patients undergoing complex spine surgery using a standard anesthetic, average hydromorphone consumption in the first 24 hours was 27 mg (18). The investigators expect to see at least a 33% reduction in hydromorphone consumption in the methadone group. Group sample sizes of 39 and 39 achieve 91% power to detect a difference of 9.0 between the null hypothesis that both group means are 27.0 and the alternative hypothesis that the mean of group 2 is 18.0 with estimated group standard deviations of 10.0 and 10.0 and with a significance level (alpha) of 0.01000 using a two-sided two-sample t-test. The investigators plan to enroll a total of 100 patients to ensure complete collection of data.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methadone and Hydromorphone For Spinal Surgery
Actual Study Start Date : March 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: methadone group
Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Drug: Methadone
Methadone 0.2 mg/kg administered at induction of anesthesia

Active Comparator: Hydromorphone group
Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Drug: Hydromorphone
Hydromorphone 2 mg administered at the conclusion of anesthesia




Primary Outcome Measures :
  1. Hydromorphone Use at 24 Hours [ Time Frame: Use of hydromorphone at 24 hours ]

Secondary Outcome Measures :
  1. Hydromorphone Use Second 24 Hours [ Time Frame: 24-48 hours after surgery ]
  2. Hydromorphone Use Third 24 Hours [ Time Frame: 48-72 hours after surgery ]
  3. Pain Scores Postanesthesia Care Unit (PACU) Arrival [ Time Frame: First 5 minutes after PACU arrival ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  4. Pain Scores 1 Hour After PACU Arrival [ Time Frame: Pain scores at 60 minutes after PACU admission ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  5. Pain Scores 2 Hours After PACU Arrival [ Time Frame: Pain scores at 120 minutes after PACU admission ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  6. Pain Scores on Postoperative Day One [ Time Frame: Pain scores one day after PACU admission ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  7. Pain Scores on Postoperative Day 2 [ Time Frame: Pain scores 48 hours after PACU admission ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  8. Pain Scores Postoperative Day 3 [ Time Frame: Pain scores 72 hours after PACU admission ]
    11-point verbal rating scale (0=no pain, 10=worst pain imaginable)

  9. Patient Satisfaction Scores [ Time Frame: Postopertive day 1 ]
    Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

  10. Patient Satisfaction Scores [ Time Frame: postoperative day 2 ]
    Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

  11. Patient Satisfaction Scores [ Time Frame: Postoperative day 3 ]
    Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))

  12. Chronic Persistent Surgical Pain-Weekly Frequency of Pain [ Time Frame: One month after surgery ]
    0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

  13. Chronic Persistent Surgical Pain-weekly Frequency of Pain [ Time Frame: 3 months after surgery ]
    0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

  14. Chronic Persistent Surgical Pain-Weekly Frequency of Pain [ Time Frame: 6 months after surgery ]
    0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant

  15. Chronic Persistent Surgical Pain-Weekly Frequency of Pain [ Time Frame: 12 months after surgery ]
    0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02107339


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Glenn S Murphy, MD NorthShore University HealthSystem
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Responsible Party: Glenn Murphy, Director, Clinical Research, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02107339    
Other Study ID Numbers: EH14-113
First Posted: April 8, 2014    Key Record Dates
Results First Posted: August 16, 2016
Last Update Posted: September 30, 2019
Last Verified: September 2019
Keywords provided by Glenn Murphy, NorthShore University HealthSystem:
methadone
hydromorphone
acute postoperative pain
chronic persistent surgical pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Methadone
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents