Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 110 people enrolled
- Started
- 18 Jan 2022
- Ended
- 29 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Bupivacaine
- Morphine
- Lidocaine
- Record updated
- 31 July 2025
- Why it stopped
- Low accrual
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
- Patient currently taking more than 30 MME a day preoperatively (for >30 days)
- Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set
- Moderate to severe kidney or liver failure per lab criteria as outlined
- 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
- Patients not giving consent to participate in the study
- Unable to complete self-report pain questionnaire
- Complete bowel obstruction
- Contraindication to intravenous lidocaine
- No known pregnancy and not lactating
- Currently septic
- BMI >50kg/m2
Where in United States
- Washington University School of MedicineSt Louis, United States
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)Existing treatment, for comparison
* Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital * Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol. * Intraoperative: dexamethasone and epidural bupivacaine * Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine * Postoperative: hydromorphone PCA, ibuprofen, oxycodone
Treatment: Bupivacaine
- Intrathecal morphine with intraoperative lidocaine infusionTreatment being tested
* Day of surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg) * Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight * Day of surgery postoperative: toradol, ibuprofen, tylenol * Postoperative: ibuprofen, oxycodone, and hydromorphone prn
Treatment: Morphine and Lidocaine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.
- Record updated
- 31 July 2025