Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With … (NCT05017246) | Clinical Trial Compass
TerminatedPhase 2
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Stopped: Low accrual
United States110 participantsStarted 2022-01-18
Plain-language summary
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients ≥18 years old
* Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
* No clinical or laboratory evidence of end organ failure:
If available:
* Platelets \> 100 K/cumm
* Hemoglobin \> 8.0 g/dl
* Serum creatinine \<1.5 mg/dl
* Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight.
* INR \<1.3 reference range
* All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value.
Exclusion Criteria:
* Patients not giving consent to participate in the study
* Unable to complete self-report pain questionnaire
* Moderate to severe kidney or liver failure per lab criteria as outlined
* Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
* Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection
* Complete bowel obstruction
* Contraindication to intravenous lidocaine
* No known pregnancy and not lactating.
* Currently septic
* Patient currently taking more than 30 MME a day preoperatively (for \>30 days)
* BMI \>50kg/m2
* Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set
What they're measuring
1
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Timeframe: Postoperatively while patient is in hospital (estimated to be 4 days)