Overview

This trial is active, not recruiting.

Conditions pain, postoperative, chronic pain
Treatments methadone, fentanyl
Phase phase 4
Sponsor NorthShore University HealthSystem Research Institute
Start date September 2010
End date November 2013
Trial size 164 participants
Trial identifier NCT01542645, ENH10-256

Summary

The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on postoperative pain and analgesic requirements in patients undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to subjects receiving a standard dose of the "traditional" intraoperative opioid (fentanyl). Secondary outcome measures to be assessed will include standard recovery variables (such as length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting, level of sedation). In addition, patients will be assessed for the development of chronic postoperative pain.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
methadone
Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
(Active Comparator)
fentanyl
Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.

Primary Outcomes

Measure
Total Opioid Consumption in the Postoperative Period
time frame: First 3 days after surgery

Secondary Outcomes

Measure
Postoperative Pain Scores
time frame: 2 hours after cardiac surgery
Chronic Postoperative Pain Scores
time frame: 1,3,6, and 12 months after surgery
Marker of Myocardial Injury (Troponin I)
time frame: 12 hours after surgery

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment. Exclusion Criteria: 1. Preoperative renal failure requiring dialysis 2. Significant hepatic dysfunction (liver function tests > 2 times upper normal limit) 3. Preoperative ejection fraction < 30% 4. Pulmonary disease necessitating home oxygen therapy 5. Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability 6. Allergy to methadone or fentanyl 7. Preoperative pain, use of preoperative opioids, or recent history of opioid abuse

Additional Information

Principal investigator Glenn S. Murphy, MD
Description Patients will be randomized to receive either methadone or fentanyl on the basis of a computer generated random number table. Patients in each group will receive standard intraoperative doses of either methadone or fentanyl that will allow for early tracheal extubation (within 4-8 hours of the conclusion of the surgical procedure). Study infusions will be prepared by the pharmacy, and all clinicians will be blinded to group assignment (methadone group-0.3 mg/kg-100 mL normal saline; fentanyl group-12 μg/kg-100 mL normal saline). Pain will be assessed by blinded observers using a 11-point verbal analogue scale (0=no pain, 10=worst pain imaginable). Assessment for pain will be performed 15 minutes post-extubation and then 2, 4, 8, 12, 24, 48, and 72 hours after tracheal extubation. Pain will be determined at rest, with coughing, and during movement. At the same time pain data is collected, several other clinical assessments will be completed. The presence or absence of nausea and vomiting will be determined, and severity quantified using a 4-point ordinal scale (0=none, 3=severe). Level of sedation will be measured by observers using a 4-point sedation scale (0=fully awake, 1=mildly sedated (seldom drowsy and easy to awake), 2=moderately sedated (often drowsy and easy to awake), 3=severely sedated (somnolent, difficult to awake). Pruritis will also be measured using a 4-point scale (0=none, 3=severe). Any episodes of hypoventilation (respiratory rate < 8 breaths/min) or hypoxemia (oxygen saturation < 90%) during the study period will be recorded. Patient satisfaction with overall pain management will be determined using a 100-point verbal rating scale (1=highly dissatisfied (worst), 100=highly satisfied (best)). Respiratory rate, oxygen saturation (in ICU), and mean arterial blood pressure at the time of evaluation will be noted. Postoperative pain will be managed according to standard institutional protocols. In the ICU, intravenous morphine will be administered for initial pain management (1 mg for mild-moderate pain, 2 mg for moderate-severe pain). Patients will be transitioned to oral pain medication when oral intake is tolerated (Norco tablets). The amount of pain medication administered during each study interval (listed above) will be recorded. Other standard recovery variables will be recorded. These include time of initiation of ventilator weaning, time of tracheal extubation, arterial blood gas following extubation, time of ICU discharge, and time of hospital discharge. Time of first flatus and bowel movement will be recorded. Any complications during the hospitalization will be recorded. In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect. Patients will be provided with a survey and self-addressed envelope following discharge from the hospital to determine the presence or absence of chronic persistent surgical pain. These data will be mailed by each patient 1, 3, 6, and 12 months postoperatively. The survey will assess the nature and severity of pain related to the surgical procedure.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by NorthShore University HealthSystem Research Institute.