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
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Methadone
Drug: Hydromorphone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546948

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
  More Information

No publications provided

Responsible Party: Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01546948     History of Changes
Other Study ID Numbers: EH11-232
Study First Received: March 3, 2012
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
Methadone
Hydromorphone
Hepatobiliary surgery
Postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Hydromorphone
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014