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Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.

ConditionTesticular Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-80
SponsorIndiana University

About this trial

This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC

ASA Class 1, 2, 3

Age 18 to 80 years; Male

BMI less than 50kg/m2

Disqualifiers

Any contraindication for neuraxial analgesia

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inrathecal Morphine

    Drug

    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

    Drug

    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)

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Intrathecal MorphineOther 1 intervention
Group B: Intravenous MethadoneOther 1 intervention

Trial outcomes

Primary outcomes

1

IV morphine equivalent (MME)

Cumulative Milligrams of morphine equivalent (MME) consumption

Time frame
First 24 hours postoperative

Secondary outcomes

1

Opioid consumption

Opioid consumption in morphine equivalent (MME)

Time frame
1 hour after arrival time to post anesthesia care unit
2

Opioid consumption

Opioid consumption in morphine equivalent (MME)

Time frame
12 hours after arrival time to post anesthesia care unit
3

Opioid consumption

Opioid consumption in morphine equivalent (MME)

Time frame
24 hours after arrival time to post anesthesia care unit
4

Opioid side effect-Nausea

Incidence of opioid side effects-nausea

Time frame
after arrival time to post anesthesia care unit until 24 hours/completion of study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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