Clinical trial NCT06593665: Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
Official title: Randomized Prospective Study Comparing Intrathecal Morphine Vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Testicular Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 142
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 142 subjects will be randomized by a computer program into two groups.

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)
Primary purpose: OTHER

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: IV morphine equivalent (MME)
timeFrame: First 24 hours postoperative
Secondary outcomes:
measure: Opioid consumption
timeFrame: 1 hour after arrival time to post anesthesia care unit
measure: Opioid consumption
timeFrame: 12 hours after arrival time to post anesthesia care unit
measure: Opioid consumption
timeFrame: 24 hours after arrival time to post anesthesia care unit
measure: Opioid side effect-Nausea
timeFrame: after arrival time to post anesthesia care unit until 24 hours/completion of study
measure: Opioid side effects-Vomiting
timeFrame: after arrival time to post anesthesia care unit until 24 hours/completion of study
measure: Opioid side effects-Pruritis
timeFrame: after arrival time to post anesthesia care unit until 24 hours/completion of study
measure: Adverse Events
timeFrame: after arrival time to post anesthesia care unit until 24 hours/completion of study
measure: Opioid side effects-Respiratory Depression
timeFrame: after arrival time to post anesthesia care unit until 24 hours/completion of study
measure: Pain Scores
timeFrame: 24 hours after arrival time to post anesthesia care unit
measure: Pain Scores
timeFrame: 12 hours after arrival time to post anesthesia care unit
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Univeristy
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Gulraj S Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References: