Testicular CancerPhase 3RPLNDNCT06593665
Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
A Phase 3 study testing Inrathecal Morphine and Intravenous Methadone in people with Testicular Cancer, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Inrathecal Morphine and Intravenous Methadone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Indiana Univeristy
Indianapolis, Indiana, 46202
Lyla Farlow, LPN, 317-984-9804, lychrist@iupui.edu
Angie Plummer, LPN, 317-944-7239, plummera@iupui.edu
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
3179489804, lychrist@iupui.edu
About this study
Official title: Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
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.
Read the 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.
- Conditions
- Testicular Cancer
- Being tested
- Inrathecal Morphine, Intravenous Methadone
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inrathecal MorphineDrug
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 MethadoneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Other | 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) Receives: Drug: Inrathecal Morphine |
| Intravenous Methadone | Other | 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) Receives: Drug: Intravenous Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV morphine equivalent (MME)
Cumulative Milligrams of morphine equivalent (MME) consumption
Measured: First 24 hours postoperative
Secondary outcomes (10)
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Measured: 1 hour after arrival time to post anesthesia care unit
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Measured: 12 hours after arrival time to post anesthesia care unit
Opioid consumption
Opioid consumption in morphine equivalent (MME)
Measured: 24 hours after arrival time to post anesthesia care unit
Opioid side effect-Nausea
Incidence of opioid side effects-nausea
Measured: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Vomiting
Incidence of opioid side effects-vomiting
Measured: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Pruritis
Incidence of opioid side effects-pruritis
Measured: after arrival time to post anesthesia care unit until 24 hours/completion of study
Adverse Events
Incidence of adverse events
Measured: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Respiratory Depression
Incidence of opioid side effects-respiratory depression
Measured: after arrival time to post anesthesia care unit until 24 hours/completion of study
Pain Scores
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
Measured: 24 hours after arrival time to post anesthesia care unit
Pain Scores
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
Measured: 12 hours after arrival time to post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Michael Backfish-White, MD, Indiana University
- Investigators
- Gulraj S Chawla, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593665
- Sponsor's protocol ID
- 22103
- Acronym
- RPLND
- Status last verified
- Nov 2025
- First submitted
- 6 Sep 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
- ClinicalTrials.gov ID
- NCT06593665
- Acronym / sponsor ID
- RPLND / 22103
- Conditions
- Testicular Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Other | Drug: Inrathecal MorphineIntrathecal 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 | Other | Drug: Intravenous MethadoneIntravenous 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inrathecal MorphineIntrathecal 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) | Drug | Intrathecal Morphine |
| Intravenous MethadoneIntravenous 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) | Drug | Intravenous Methadone |
Primary outcome
IV morphine equivalent (MME)
Time frame: First 24 hours postoperative
Cumulative Milligrams of morphine equivalent (MME) consumption
10 secondary outcomes
Opioid consumption
Time frame: 1 hour after arrival time to post anesthesia care unit
Opioid consumption
Time frame: 12 hours after arrival time to post anesthesia care unit
Opioid consumption
Time frame: 24 hours after arrival time to post anesthesia care unit
Opioid side effect-Nausea
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Vomiting
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Pruritis
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Adverse Events
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Opioid side effects-Respiratory Depression
Time frame: after arrival time to post anesthesia care unit until 24 hours/completion of study
Pain Scores
Time frame: 24 hours after arrival time to post anesthesia care unit
Pain Scores
Time frame: 12 hours after arrival time to post anesthesia care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gulraj S Chawla, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inrathecal Morphine and Intravenous Methadone in people with Testicular Cancer, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyla S Farlow (3179489804, lychrist@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV morphine equivalent (MME) (time frame: First 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.