Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery

NCT01546948 | Completed Phase 4

• 1 other identifier: EH11-232
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Methadone; Hydromorphone; Hepatobiliary surgery; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain medication used (hydromorphone)

  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.

  First 72 hours after surgery

Secondary Outcomes (3)

• Postoperative pain scores

  First 72 hours after sugery

• The presence or absence of nausea and vomiting

  First 72 hours after surgery

• Level of sedation

  First 72 hours after surgery

Study Arms (2)

Methadone

EXPERIMENTAL

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

Hydromorphone

ACTIVE COMPARATOR

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

Interventions

Methadone DRUG

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.

Methadone

Hydromorphone DRUG

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.

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Preoperative renal failure (defined as a serum creatinine \> 2.0 mg/dL.)
• Morbid obesity
• American Society of Anesthesiologists Physical Status IV or V
• Age \> 80 years
• Pulmonary disease necessitating home oxygen therapy
• Allergy to methadone or hydromorphone
• Preoperative recent history of opioid or alcohol abuse

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2012
• First Posted: March 7, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 21, 2021

Record last verified: 2019-09

Locations

US (1)