Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Methadone; Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the methadone group will be administered 0.3 mg/kg of methadone intraoperatively: 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.; Patients in the hydromorphone group will receive 0.03 mg/kg of hydromorphone; 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.
Intervention MeSH terms: Methadone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methadone; Hydromorphone; Hepatobiliary surgery; Postoperative pain