Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01546948
First received: March 3, 2012
Last updated: March 26, 2014
Last verified: March 2014

March 3, 2012
March 26, 2014
August 2011
December 2013   (final data collection date for primary outcome measure)
Postoperative pain medication used (hydromorphone) [ Time Frame: First 72 hours after surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01546948 on ClinicalTrials.gov Archive Site
  • Postoperative pain scores [ Time Frame: First 72 hours after sugery ] [ Designated as safety issue: No ]
    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 [ Time Frame: First 72 hours after surgery ] [ Designated as safety issue: No ]
    The presence or absence of nausea and vomiting will be determined by a blinded research assistant
  • Level of sedation [ Time Frame: First 72 hours after surgery ] [ Designated as safety issue: No ]
    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).
Same as current
Not Provided
Not Provided
 
Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery
Not Provided

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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: Methadone
    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.
  • Drug: Hydromorphone
    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.
  • Experimental: Methadone
    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.
    Intervention: Drug: Methadone
  • Active Comparator: Hydromorphone
    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: Drug: Hydromorphone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients presenting for elective hepatobiliary or foregut surgery will be eligible for enrollment

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01546948
EH11-232
No
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
NorthShore University HealthSystem Research Institute
Not Provided
Not Provided
NorthShore University HealthSystem Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP