ITM vs ITM+Clonidine for Lumbar Fusions
ConditionLumbar Fusion Surgery
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMaineHealth
About this trial
Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery.
We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery.
Participants in this study will either get morphine injected during surgery (current pain treatment) or morphine and another drug, clonidine. There is an equal chance of getting the two treatment options. No matter which group you are assigned to, you will be provided with additional pain medication if needed after your surgery.
You may not directly benefit from participating in this study, but you might have an improvement in your pain after surgery. You will also be helping researchers and doctors find better pain control options for future patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-70 years of age
Scheduled for 1-2 level lumbar fusion
Expected post-operative inpatient stay of at least 24 hours
ASA I-III
Disqualifiers
Substance use disorder
Chronic pain (opioid use of 90 MME daily prior to surgery)
BMI > 40
Allergies to clonidine or morphine
Trial design
Design model
Parallel
Treatments tested in this trial
Intrathecal Morphine + Intrathecal Clonidine
DrugParticipants in the intervention group will receive the standard of care (150 mcg of intrathecal morphine) with the addition of 75 mcg of clonidine.
Intrathecal Morphine
DrugParticipants in this group will receive the standard of care; 150 mcg of intrathecal morphine
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Intrathecal MorphineActive comparator 1 intervention
Group B: Intrathecal Morphine + Intrathecal ClonidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative opioid consumption
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
Time frame
24 hours post-opSecondary outcomes
1
Pain scores
Pain levels as measured using the numeric rating scale (NRS) of 0-10
Time frame
72 hours post-op2
Post-operative opioid consumption
Post-operative opioid consumption measured as morphine milligram equivalents (MME)
Time frame
72 hours post-opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: