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

Phase 3

Recruiting

• Conditions: Testicular Cancer
• Interventions: Drug: Inrathecal Morphine; Drug: Intravenous Methadone

• Registration Number: NCT06593665
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

In this study, investigators aim to compare intravenous methadone combined with standard multimodal analgesia and surgical infiltration of local anesthesia to intrathecal duramorph with standard multimodal analgesia and surgical infiltration of local anesthesia. In this single blinded prospective randomized control trial, investigators hypothesize that intravenous methadone will provide a significant reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 24 hours in patients who undergo PC/RPLND.

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-09
• Study Start: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 142

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Morphine	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	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)

Primary Outcome Measures

Name	Time	Method
IV morphine equivalent (MME)	First 24 hours postoperative	Cumulative Milligrams of morphine equivalent (MME) consumption

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	24 hours after arrival time to post anesthesia care unit	Opioid consumption in morphine equivalent (MME)
Opioid side effect-Nausea	after arrival time to post anesthesia care unit until 24 hours/completion of study	Incidence of opioid side effects-nausea
Opioid side effects-Vomiting	after arrival time to post anesthesia care unit until 24 hours/completion of study	Incidence of opioid side effects-vomiting
Opioid side effects-Pruritis	after arrival time to post anesthesia care unit until 24 hours/completion of study	Incidence of opioid side effects-pruritis
Adverse Events	after arrival time to post anesthesia care unit until 24 hours/completion of study	Incidence of adverse events
Opioid side effects-Respiratory Depression	after arrival time to post anesthesia care unit until 24 hours/completion of study	Incidence of opioid side effects-respiratory depression
Pain Scores	12 hours after arrival time to post anesthesia care unit	Visual Analog Scale (VAS) pain score On a scale of 1 to 10 (increments of 1 unit), 1 being no pain at all, 10 being the most pain the patient has ever experienced

Trial Locations

Locations (2)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana Univeristy; 🇺🇸 Indianapolis, Indiana, United States