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

Fibroid Uterus Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017246
• Other study ID #: 202105007
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Premal H Thaker, M.D., MS
• Phone: 314-747-3604
• Email: thakerp[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adnexal Mass
• Fibroid Uterus
• Leiomyoma

Intervention

Drug:
• Bupivacaine
-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
• Morphine
-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
• Lidocaine
-Lidocaine infusion 1 mg/kg ideal body weight (IBW)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine milligram equivalent (MME) in the postoperative hospital course		Postoperatively while patient is in hospital (estimated to be 4 days)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	30 day readmission rate		Through day 30
Secondary	Rate of deep vein thrombosis (DVT)		From day of surgery (day 1) to 6 weeks after surgery
Secondary	Rate of pulmonary thromboembolism (PTE)		From day of surgery (day 1) to 6 weeks after surgery
Secondary	Rate of persistent pain	-As determined by an NRS pain score = 5	At 6 week follow-up

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine