Morphine vs Methadone for Post-Surgery Pain in Testicular Cancer
(RPLND Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Indiana University
Must not be taking: Methadone
Disqualifiers: Substance abuse, Liver disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on methadone or taking more than 30mg of morphine equivalent per day.
What data supports the effectiveness of the drugs used for post-surgery pain in testicular cancer?
Research shows that intravenous methadone is effective for managing pain after surgery and can reduce the need for other painkillers without causing more side effects. Intrathecal morphine has been found to provide better and longer-lasting pain relief compared to methadone in some studies, although methadone requires less frequent dosing.
12345Is it safe to use morphine or methadone for post-surgery pain?
Both morphine and methadone have been used safely for pain relief after surgery, but they can cause side effects like nausea, vomiting, and drowsiness. Methadone at higher doses may lead to more serious side effects like respiratory depression (trouble breathing) and low blood pressure.
12467How does the drug for post-surgery pain in testicular cancer differ from other treatments?
This treatment is unique because it compares intrathecal morphine and intravenous methadone, focusing on their different administration routes and effects. Methadone is noted for its long-lasting pain relief and lower opioid consumption, while morphine provides more immediate but shorter-term relief. Methadone is also less commonly used, despite its potential benefits in managing difficult pain conditions.
13489Eligibility Criteria
This trial is for patients with primary testicular cancer who are undergoing retroperitoneal lymph node dissection. Specific eligibility criteria details were not provided, so interested individuals should inquire further to determine if they qualify.Inclusion Criteria
ASA Class 1, 2, 3
BMI less than 50kg/m2
I am a man aged between 18 and 80.
+1 more
Exclusion Criteria
I cannot have spinal or epidural pain relief.
Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
I have had surgery with an incision different from the usual for my condition.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either intrathecal morphine or intravenous methadone for postoperative analgesia following retroperitoneal lymph node dissection
Immediate postoperative period
1 visit (in-person)
Follow-up
Participants are monitored for opioid consumption, side effects, and pain scores for 24 hours postoperatively
24 hours
1 visit (in-person)
Participant Groups
The study aims to compare the pain management effectiveness of intrathecal morphine and intravenous methadone in postoperative care after surgery for testicular cancer. It's a randomization study, meaning patients will be randomly assigned one of the two standard treatments.
2Treatment groups
Experimental Treatment
Group I: Intravenous MethadoneExperimental Treatment1 Intervention
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)
Group II: Intrathecal MorphineExperimental Treatment1 Intervention
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)
Intrathecal Morphine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Morphine for:
- Severe chronic pain
- Acute pain
- Labor analgesia
- Perioperative analgesia for intra-abdominal, intra-thoracic, and orthopedic surgery
- Perioperative analgesia for Cesarean section
🇪🇺 Approved in European Union as Morphine for:
- Severe chronic pain
- Acute pain
- Labor analgesia
- Perioperative analgesia for intra-abdominal, intra-thoracic, and orthopedic surgery
- Perioperative analgesia for Cesarean section
🇨🇦 Approved in Canada as Morphine for:
- Severe chronic pain
- Acute pain
- Labor analgesia
- Perioperative analgesia for intra-abdominal, intra-thoracic, and orthopedic surgery
- Perioperative analgesia for Cesarean section
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniveristyIndianapolis, IN
Indiana University HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
Intravenous Methadone for Perioperative and Chronic Cancer Pain: A Review of the Literature. [2023]Intravenous methadone may be useful in acute and chronic pain management compared with other opioids because of its pharmacokinetic and pharmacodynamic characteristics, including the long duration of effect and ability to modulate both pain stimuli propagation and analgesic descending pathways. However, methadone is underused in pain medicine because of several misperceptions. A review of studies was performed to assess data regarding the use of methadone in perioperative pain and chronic cancer pain. The majority of studies have shown that intravenous methadone produces an effective postoperative analgesia and lowers opioid consumption in the postoperative period, without more adverse effects in comparison with other opioid analgesics, and has an interesting potential to prevent persistent postoperative pain. A minority of studies investigated the use of intravenous methadone for cancer pain management. These studies were mostly case series that showed promising activities of intravenous methadone for difficult pain conditions. There is sufficient evidence suggesting that intravenous methadone is effective in perioperative pain, while more studies are needed in patients with cancer pain.
Pitfalls of opioid rotation: substituting another opioid for methadone in patients with cancer pain. [2021]The successful use of methadone in cancer pain has been supported by numerous case reports and clinical studies. Methadone is usually used as a second or third line opioid medication. As the use of methadone increases we are facing the challenge of converting methadone to other opioids as part of sequential opioid trials. Data on the equianalgesic ratios for the substitution of other opioids for methadone are lacking. We present prospective data on 13 consecutive rotations from methadone to a different opioid. The opioid rotation was followed by escalation of pain and/or severe dysphoria, not controlled by a rapid increase in the dose of the second opioid, in 12 of the 13 patients. Only one patient was successfully maintained on the second opioid after the discontinuation of methadone, while 12 patients required a switch back to methadone. We conclude that opioid rotation from methadone to another opioid is often complicated by worsening pain and dysphoria. These symptoms may not improve despite upward titration of the second opioid. A uniformly accepted conversion ratio for substituting methadone with another opioid is currently not available. More data on the rotation from methadone to other opioids are needed.
A double-blind comparison of the efficacy of methadone and morphine in postoperative pain control. [2022]This study reports the results of a double-blind, parallel-group comparison of intravenous methadone with morphine for the control of postoperative pain. Twenty patients (ASA Status 1 or 2) undergoing a surgical procedure involving an upper abdominal incision were randomly allocated to the methadone (n = 10) or morphine (n = 10) treatment groups. The patients were administered a 20-mg intraoperative opioid dose and 5-mg intravenous increments of opioid from precoded syringes in response to pain in the recovery and surgical wards. There was no significant difference between the mean +/- SD amount of supplementary methadone (8 +/- 6.3 mg) and morphine (9 +/- 9 mg) required in the recovery ward to provide initial pain control. The time from initial pain control to the first supplementary dose in the surgical ward was significantly different (P less than 0.01) in the methadone group (20.7 +/- 20.2 h) when compared to the morphine group (6.2 +/- 3.0 h). Further, patients required significantly less (P less than 0.001) methadone (11.5 +/- 8.5 mg) than morphine (41 +/- 14.1 mg) in the surgical ward to provide adequate pain relief throughout the duration of the study (i.e., 60 h). There was a significant difference in visual analogue pain scores between the methoadone and morphine groups on postoperative days 1 and 2, suggesting the quality of pain relief was similar for both treatment groups. Blood opioid-concentration monitoring indicated that there was a relationship between blood opioid concentration and pain relief.(ABSTRACT TRUNCATED AT 250 WORDS)
Intrathecal methadone and morphine for postoperative analgesia: a comparison of the efficacy, duration, and side effects. [2019]A double-blind study of patients selected at random compared the analgesic and adverse effects of intrathecal methadone (1 mg) with those of intrathecal morphine (0.5 and 1 mg). The study was conducted on 30 patients who underwent major orthopedic or urologic surgery. The intrathecal opioid was administered at the end of surgery, and assessments began 1 h thereafter and continued for 20 h. Pain measurements, supplementary analgesia requirements, and adverse effects were recorded. Intrathecal morphine (0.5 and 1 mg) provided effective and prolonged analgesia. Methadone, however, was unable to ensure the same degree of analgesia; consequently, the median pain scores were consistently higher following methadone than morphine (0.5 and 1 mg) (P less than 0.05). The time to the onset of discomfort severe enough to require supplemental morphine was longer after intrathecal morphine than that following methadone (24 and 29 h with morphine 0.5 and 1 mg; 6.5 h with methadone; P less than 0.05). Respiratory depression (increases PaCO2) was not associated with methadone and morphine 0.5 mg but was common following morphine 1 mg (P less than 0.05). Facial pruritus was unique to intrathecal morphine. Urinary retention requiring bladder catheterization was more frequent following morphine than methadone, although this was not statistically significant. Nausea and vomiting were common to all groups. Intrathecal morphine (0.5 and 1 mg) provides superior postoperative analgesia to 1 mg methadone. Various explanations for the observed differences between the drugs are discussed, including the possibility that the dose of methadone used in the subarachnoid space was inadequate and that a larger dose might have produced an effect equal to that of morphine.
Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia. [2023]The purpose of the present study was to compare the effectiveness of intrathecal injection of morphine, inserted in the protocols of multimodal analgesia, versus intravenous morphine in the control of postoperative pain and course in women undergoing gynecological surgery.
Intrathecal methadone: a dose-response study and comparison with intrathecal morphine 0.5 mg. [2021]The analgesic and adverse effects of intrathecal methadone 5 mg, 10 mg and 20 mg were assessed and compared with intrathecal morphine 0.5 mg. The study was conducted on 38 patients who underwent total knee or hip replacement surgery. The intrathecal opioid was administered at the end of surgery and assessments began 1 h thereafter and continued for 24 h. Pain measurements, supplementary analgesia requirements, and adverse effects were recorded. Intrathecal morphine 0.5 mg provided effective and prolonged analgesia. Intrathecal methadone 5 mg, 10 mg, and 20 mg produced good analgesia of 4 h duration. Thereafter the median pain scores with intrathecal methadone were consistently higher (worse) than those with intrathecal morphine (P less than 0.05). The time to the onset of discomfort severe enough to require supplemental morphine was longer after intrathecal morphine than following methadone (15 h with morphine 0.5 mg; 6.25 h, 6.5 h and 6 h with methadone 5 mg, 10 mg, and 20 mg respectively: P less than 0.05). Central nervous system depression manifesting as respiratory depression, hypotension, and excessive drowsiness occurred in 3 of 8 patients injected with methadone 20 mg intrathecally. Generalized pruritus, nausea, vomiting, and urinary retention were common and equally distributed among the treatment groups. We conclude that both intrathecal morphine 0.5 mg and methadone 5, 10, and 20 mg provide excellent analgesia but that morphine has a more prolonged effect. Methadone 20 mg produced unacceptable side effects. Clinical evidence for rostral spread of methadone within the CSF, as indicated by facial itching and excessive drowsiness, was less apparent with 5 mg than with 10 and 20 mg. Various explanations for the observed differences between the drugs are discussed.
Long-term intrathecal opioid therapy with a patient-activated, implanted delivery system for the treatment of refractory cancer pain. [2022]The present study evaluated the safety and efficacy of patient-activated delivery of intrathecal morphine sulfate boluses delivered by way of a novel internalized intrathecal delivery system. Patients with refractory cancer pain or uncontrollable side effects were enrolled at 17 US and international sites in this prospective, open-label study. Pain relief, reduction in systemic opioid use, and reduction in opioid-related complications were analyzed both individually and together as a measure of overall success. One hundred forty-nine patients were enrolled and 119 were implanted. Average numeric analog scale pain decreased from 6.1 to 4.2 at 1 month and was maintained through month 7 (P /=50% reduction in numeric analog scale pain, use of systemic opioids, or opioid complication severity index) was reported in 83%, 90%, 85%, and 91% of patients at months 1, 2, 3, and 4, respectively. This study demonstrated that patients with refractory cancer pain or intolerable side effects achieved better analgesia when managed with patient-activated intrathecal delivery of morphine sulfate via an implanted delivery system.
Methadone rotation for cancer patients with refractory pain in a palliative care unit: an observational study. [2013]Methadone has been reported to be as effective as morphine for cancer pain management. It is commonly used as an alternative opioid in case of insufficient relief.
Rotating to oral methadone in advanced cancer patients: a case series. [2013]Methadone is increasingly being used to treat patients whose pain does not respond well to other opioids. Advantages over morphine sulphate and its alternatives include low cost, lack of active metabolites and efficacy against neuropathic pain.