Evanston, Illinois 60201

  • Postoperative Pain

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.


Study summary:

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).


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


Study is Available At:


Original ID:

EH11-232


NCT ID:

NCT01546948


Secondary ID:


Study Acronym:


Brief Title:

Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery


Official Title:

Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NorthShore University HealthSystem


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Glenn S Murphy, MD
Principal Investigator
NorthShore University HealthSystem

Study Dates

Start Date:August 2011
Completion Date:December 2020
Completion Type:Anticipated
Primary Completion Date:December 2020
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 12, 2019
First Received Date:March 3, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Level of sedation
Time Frame:First 72 hours after surgery
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:The presence or absence of nausea and vomiting
Time Frame:First 72 hours after surgery
Safety Issues:False
Description:The presence or absence of nausea and vomiting will be determined by a blinded research assistant
Outcome Type:Secondary Outcome
Measure:Postoperative pain scores
Time Frame:First 72 hours after sugery
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Postoperative pain medication used (hydromorphone)
Time Frame:First 72 hours after surgery
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Hydromorphone
Description: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.
Arm Name:Hydromorphone
Intervention Type:Drug
Name:Methadone
Description: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.
Arm Name:Methadone

Study Arms

Study Arm Type:Active Comparator
Arm Name:Hydromorphone
Description: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.
Study Arm Type:Experimental
Arm Name:Methadone
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:NorthShore University HealthSystem

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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