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

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Enlarged Uterus; Fibroid Uterus; Adnexal Mass; Cancer Debulking

Treatments: Drug: Lidocaine; Drug: Morphine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05017246

202105007

Details and patient eligibility

About

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).

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)

Active Comparator group

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

Treatment:

Drug: Bupivacaine

Intrathecal morphine with intraoperative lidocaine infusion

Experimental group

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

Treatment:

Drug: Morphine

Drug: Lidocaine