Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
NCT ID: NCT06593665
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
142 participants
INTERVENTIONAL
2024-09-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Intrathecal preservative free morphine (duramorph) 200mcg with 7.5 mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
2. Intravenous methadone dose at 0.2mg/kg Ideal Body weight up to a maximum dose of 20 mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
OTHER
DOUBLE
Study Groups
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Intrathecal Morphine
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
Inrathecal Morphine
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
Intravenous Methadone
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Intravenous Methadone
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Interventions
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Inrathecal Morphine
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
Intravenous Methadone
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
Eligibility Criteria
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Inclusion Criteria
* ASA Class 1, 2, 3
* Age 18 to 80 years; Male
* BMI less than 50kg/m2
Exclusion Criteria
* Patient on home methadone at any dose
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known true allergy to the study medications (morphine, bupivacaine, acetaminophen, methadone)
* Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
* End stage liver disease, end stage renal disease
* Patient staying intubated after surgery
* Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
* Any additional surgical procedures to the patient with a different surgical incision compared to the standard laparotomy for the RPLND procedure, i.e. thoracic tumor reduction
18 Years
80 Years
MALE
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Gulraj Chawla
Dept. of Anesthesiology, Asst. Professor
Principal Investigators
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Gulraj S Chawla, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana Univeristy
Indianapolis, Indiana, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Gulraj S Chawla, MD
Role: backup
Role: primary
Other Identifiers
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22103
Identifier Type: -
Identifier Source: org_study_id
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