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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    174
  • sponsor
    Washington University School of Medicine
Updated on 7 October 2022
laparotomy
lidocaine

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).

Details
Condition Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
Treatment Morphine, lidocaine, Bupivacaine
Clinical Study IdentifierNCT05017246
SponsorWashington University School of Medicine
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 or contraindication to receiving non-steroidal anti-inflammatory drugs or acetaminophen
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