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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Morphine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)<br>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 | Drug: Bupivacaine<br>* -Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP<br>|
| Experimental: Intrathecal morphine with intraoperative lidocaine infusion<br>Day or 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 | Drug: Morphine<br>* -Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)<br>* Other names: Duramorph;Drug: Lidocaine<br>* -Lidocaine infusion 1 mg/kg ideal body weight (IBW)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine milligram equivalent (MME) in the postoperative hospital course |  | Postoperatively while patient is in hospital (estimated to be 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Fisher's exact test will be used to compare non-paired nominal data. | 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 on EPIC (days). | 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. | 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). | 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. | Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up | 
| 30 day readmission rate |  | Through day 30 | 
| Rate of deep vein thrombosis (DVT) |  | From day of surgery (day 1) to 6 weeks after surgery | 
| Rate of pulmonary thromboembolism (PTE) |  | From day of surgery (day 1) to 6 weeks after surgery | 
| Rate of persistent pain | -As determined by an NRS pain score ≥ 5 | At 6 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus