Clinical trial · Interventional
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
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.
NCT05017246CI-TRIAL-00092851terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Mass | — | UNRESOLVED | — |
| Cancer Debulking | — | UNRESOLVED | — |
| Enlarged Uterus | — | UNRESOLVED | — |
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)
- description
- * 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
- interventionNames
- Drug: Bupivacaine
- type
- EXPERIMENTAL
- label
- Intrathecal morphine with intraoperative lidocaine infusion
- description
- * 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
- interventionNames
- Drug: Morphine
- Drug: Lidocaine
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.