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Opioid Analgesic

Intrathecal Morphine + Lidocaine vs Epidural Anesthesia for Exploratory Laparotomy Pain Management

Phase 2
Recruiting
Led By Michael D Toboni, M.D., MPH
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No clinical or laboratory evidence of end organ failure: 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
Female patients ≥18 years old undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours after surgery
Awards & highlights

Study Summary

This trial is testing whether patients who receive intrathecal morphine and lidocaine during surgery will consume less opioids postoperatively than those who receive epidural anesthesia with PCA.

Who is the study for?
This trial is for women over 18 undergoing non-emergency exploratory laparotomy with the Gynecologic Oncology service. They must have stable organ function, no severe kidney or liver issues, not be pregnant or breastfeeding, and not on high opioid doses. Those with clotting disorders, spinal abnormalities, infections at potential injection sites, or extreme obesity (BMI >50) cannot join.Check my eligibility
What is being tested?
The study compares two pain management methods after surgery: one group receives intrathecal morphine and intraoperative lidocaine infusion (IML), while another gets epidural anesthesia with postoperative PCA (EPCA). The goal is to see which method results in lower opioid use after surgery.See study design
What are the potential side effects?
Possible side effects include reactions to bupivacaine, morphine, or lidocaine such as nausea, itching at the injection site, low blood pressure during infusion of drugs; respiratory depression from opioids; and potential nerve damage from needle placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood and organ function tests are within safe ranges.
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I am a woman over 18 having planned surgery for a gynecological issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine milligram equivalent (MME) in the postoperative hospital course
Secondary outcome measures
30 day readmission rate
Change in pain scores
Length of hospital stay
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intrathecal morphine with intraoperative lidocaine infusionExperimental Treatment2 Interventions
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
Group II: Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)Active Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
2013
Completed Phase 4
~2230
Lidocaine
2011
Completed Phase 4
~1360

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,632 Total Patients Enrolled
Michael D Toboni, M.D., MPHPrincipal InvestigatorWashington University School of Medicine
Alexander Cohen, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Morphine (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05017246 — Phase 2
Cancer Debulking Research Study Groups: Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA), Intrathecal morphine with intraoperative lidocaine infusion
Cancer Debulking Clinical Trial 2023: Morphine Highlights & Side Effects. Trial Name: NCT05017246 — Phase 2
Morphine (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017246 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have taken part in this trial thus far?

"Affirmative. Evidenced by the information on clinicaltrials.gov, this particular medical study is actively recruiting participants since its inception on January 18th 2022 and updated as recently as September 8th 2022. A total of 174 individuals are required to be recruited from one site only."

Answered by AI

For what afflictions is Morphine typically prescribed?

"Morphine is widely utilized to address small-scale burns, as well as lupus erythematosus cell, ulcerative colitis, and transplantation."

Answered by AI

Are there still openings for participants in this experiment?

"According to clinicaltrials.gov, the study is actively seeking volunteers for participation. The initial posting was published on 18 January 2022 and was most recently revised on 8 September of that same year."

Answered by AI

Has Morphine been studied in other research projects?

"At the present time, 264 trials for Morphine are in progress. Of these studies, 62 have entered Phase 3 and 1344 different clinical sites from around the globe are running them. Boston is one of many cities with an active trial looking into Morphine's efficacy."

Answered by AI

What hazards have been associated with Morphine consumption?

"Taking into account the Phase 2 status of this trial, our team at Power has ranked morphine's safety as a score of 2. This is due to limited evidence that supports its efficacy but some data indicating it can be considered safe."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
2022. "Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05017246.
All > Uterine Fibroids
~6 spots leftby May 2024
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