Clinical trial NCT05017246: Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer Debulking
Enlarged Uterus
Fibroid Uterus
Adnexal Mass
Keywords: ERAS
Multi-modal anesthesia
Opioid consumption
Intrathecal
Epidural
Ileus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Morphine milligram equivalent (MME) in the postoperative hospital course
timeFrame: Postoperatively while patient is in hospital (estimated to be 4 days)
Secondary outcomes:
measure: Rate of postoperative ileus
timeFrame: Postoperatively while patient is in hospital (estimated to be 4 days)
measure: Length of hospital stay
timeFrame: Estimated to be 4 days
measure: Rate of postoperative hypotension
timeFrame: Up to 48 hours after surgery
measure: Patient satisfaction with pain control
timeFrame: Day of hospital discharge (estimated to be day 4)
measure: Change in pain scores
timeFrame: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
measure: 30 day readmission rate
timeFrame: Through day 30
measure: Rate of deep vein thrombosis (DVT)
timeFrame: From day of surgery (day 1) to 6 weeks after surgery
measure: Rate of pulmonary thromboembolism (PTE)
timeFrame: From day of surgery (day 1) to 6 weeks after surgery
measure: Rate of persistent pain
timeFrame: At 6 week follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Premal H Thaker, M.D., MS
role: PRINCIPAL_INVESTIGATOR
References: