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Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

Recruiting
18 years of age
Female
Phase 2

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Overview

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).

Eligibility

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

Study details

Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass

NCT05017246

Washington University School of Medicine

1 June 2024

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