Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut 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: Postoperative Pain
Intervention: Methadone (Drug); Hydromorphone (Drug)
Phase: Phase 4
Status: Active, not 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
The primary aim of this randomized, double-blind study is to examine the effect of a single
intraoperative dose of methadone on analgesic requirements during the first three days after
hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a
standard dose of the "traditional" intraoperative opioid (hydromorphone). Secondary outcome
measures to be assessed will include postoperative pain scores and standard recovery
variables such as hospital length of stay.
Official title: Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Postoperative pain medication used (hydromorphone)
Postoperative pain scores
The presence or absence of nausea and vomiting
Level of sedation
60 patients will be enrolled in this clinical trial. All patients presenting for elective
hepatobiliary or foregut 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. 3 mg/kg) or hydromorphone (0. 03 mg kg).
These doses (0. 3 mg/kg of methadone or 0. 03 mg/kg of hydromorphone) represent dosages which
appear to be approximately equipotent. Study medications will be prepared by the pharmacy
in 10 cc syringes, and all clinicians will be blinded to group assignment Patients in the
methadone group will be administered two-thirds of the dose (6 cc or 0. 2 mg/kg of methadone)
on induction of anesthesia as a bolus. The remainder of the dose (3 cc or 0. 1 mg/kg of
methadone) will be administered at approximately 1. 5-2 hours before the end of the
procedure. In the hydromorphone group, patients will receive two-thirds the dose (6 cc or
0. 02 mg/kg) on induction of anesthesia, and the remainder of the hydromorphone (3 cc or 0. 01
mg/kg) will be bolused 1. 5-2 hours before surgery concludes. All other anesthestic
management will be standardized.
Data Collection The primary endpoint of the study is total dose of intravenous hydromorphone
used during the first 3 days after surgery. A blinded research assistant will record the
total doses of hydromorphone used in the PACU and with the PCA device during the first 24,
48, and 72 hour after surgery. Several secondary endpoints will be evaluated. Pain in the
postoperative period will be assessed at several time points; PACU arrival, 1, 2, 4, and 8
hours after surgery, and then approximately 8 AM and 4 PM on postoperative days 1-3. Pain
will be quantified by a blinded research assistant using an 11-point verbal rating scale
(0=no pain, 10=worst pain imaginable). Pain will be determined at rest and with coughing.
The presence or absence of nausea and vomiting will be determined. 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).
Minimum age: 18 Years.
Maximum age: 80 Years.
- All patients presenting for elective hepatobiliary or foregut surgery will be
eligible for enrollment
- Exclusion criteria include:
1. Preoperative renal failure (defined as a serum creatinine > 2. 0 mg/dL.)
2. Morbid obesity
3. American Society of Anesthesiologists Physical Status IV or V
4. Age > 80 years
5. Pulmonary disease necessitating home oxygen therapy
6. Allergy to methadone or hydromorphone
7. Preoperative recent history of opioid or alcohol abuse
Locations and Contacts
NorthShore University HealthSystem, Evanston, Illinois 60201, United States
Starting date: August 2011
Last updated: March 11, 2015