Methadone and Hydromorphone For Spinal Surgery
Information source: NorthShore University HealthSystem Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain
Intervention: Methadone (Drug); Hydromorphone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: NorthShore University HealthSystem Research Institute Official(s) and/or principal investigator(s): Glenn S Murphy, MD, Principal Investigator, Affiliation: NorthShore University HealthSystem
Overall contact: Glenn S Murphy, MD, Phone: 847-570-2760, Email: dgmurphy2@yahoo.com
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
Clinical Details
Official title: Methadone and Hydromorphone For Spinal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Hydromorphone use at 24 hours
Secondary outcome: Hydromorphone use second 24 hoursHydromorphone use third 24 hours Pain scores postanesthesia care unit (PACU) arrival Pain scores 1 hour after PACU arrival Pain scores 2 hours after PACU arrival Pain scores 4 hours after PACU arrival Pain scores on postoperative day one Pain scores on postoperative day 2 Pain scores postoperative day 3 Patient satisfaction scores Patient satisfaction scores Patient satisfaction scores Chronic persistent surgical pain Chronic persistent surgical pain Chronic persistent surgical pain Chronic persistent surgical pain
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 maintanance (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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Glenn S Murphy, MD, Phone: 847-570-2760, Email: dgmurphy2@yahoo.com
NorthShore University HealthSystem, Evanston, Illinois 60201, United States; Recruiting Glenn S Murphy, MD, Phone: 847-570-2760, Email: dgmurphy2@yahoo.com
Additional Information
Starting date: March 2014
Last updated: March 11, 2015
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