To hear about similar clinical trials, please enter your email below
Trial Title:
Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.
NCT ID:
NCT06593665
Condition:
Testicular Cancer
Conditions: Official terms:
Testicular Neoplasms
Morphine
Methadone
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Care Provider)
Masking description:
The primary investigator or his/her designee will inform the anesthesiology team caring
for each subject of the arm of the study they are in for each case. Subjects and research
staff doing post-operative assessments will be blinded to the randomization.
Intervention:
Intervention type:
Other
Intervention name:
Inrathecal Morphine
Description:
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)
Arm group label:
Intrathecal Morphine
Intervention type:
Other
Intervention name:
Intravenous Methadone
Description:
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)
Arm group label:
Intravenous Methadone
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana Univeristy
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Contact:
Last name:
Lyla Farlow, LPN
Phone:
317-984-9804
Email:
lychrist@iupui.edu
Contact backup:
Last name:
Angie Plummer, LPN
Phone:
317-944-7239
Email:
plummera@iupui.edu
Contact backup:
Last name:
Gulraj S Chawla, MD
Start date:
September 10, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06593665
