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

Phase 2TerminatedNCT05017246

Washington University School of Medicine110 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

110

Conditions

Cancer Debulking Enlarged Uterus Fibroid Uterus Adnexal Mass

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course

Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)

Secondary Outcomes

Rate of Postoperative Ileus

Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm.

Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)

Length of Hospital Stay

Length of stay will be determined by the dates of admission as recorded in EPIC (days).

Time frame: Estimated to be 4 days

Rate of Postoperative Hypotension

-Postoperative hypotension will be defined as \<90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.

Time frame: Up to 48 hours after surgery

Patient Satisfaction With Pain Control

-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).

Time frame: Day of hospital discharge (estimated to be day 4)

Change in Pain Scores

Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain. A higher score indicates more pain.

Time frame: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up

30 Day Readmission Rate

Time frame: Through day 30

Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)

Time frame: From day of surgery (day 1) to 6 weeks after surgery

Rate of Persistent Pain

-As determined by an NRS pain score ≥ 5

Time frame: At 6 week follow-up