Cancer DebulkingPhase 2NCT05017246
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
A Phase 2 study testing Bupivacaine, Morphine and Lidocaine in people with Cancer Debulking and Enlarged Uterus, run by Washington University School of Medicine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus
- What is being tested?
- Bupivacaine, Morphine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 29 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
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).
- Conditions
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
- Being tested
- Bupivacaine, Morphine, Lidocaine
- Keywords
- ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus
- Medical subject headings
- Leiomyoma, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
MorphineDrug
Also called Duramorph
-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
LidocaineDrug
-Lidocaine infusion 1 mg/kg ideal body weight (IBW)
| Study group | Role | What they receive |
|---|---|---|
| Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA) | Active comparator | * 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 Receives: Drug: Bupivacaine |
| Intrathecal morphine with intraoperative lidocaine infusion | Experimental | * Day of 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 Receives: Drug: Morphine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Measured: Postoperatively while patient is in hospital (estimated to be 4 days)
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
30 Day Readmission Rate
Measured: Through day 30
Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)
Measured: From day of surgery (day 1) to 6 weeks after surgery
Rate of Persistent Pain
-As determined by an NRS pain score ≥ 5
Measured: At 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start18 Jan 2022
- Primary completion17 Jul 2024
- Study completion29 Aug 2024
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer DebulkingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Premal H Thaker, M.D., MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017246
- Sponsor's protocol ID
- 202105007
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2021
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05017246
- Acronym / sponsor ID
- 202105007
- Conditions
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
- Keywords
- ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA) | Active comparator | Drug: Bupivacaine* 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 |
| Intrathecal morphine with intraoperative lidocaine infusion | Experimental | Drug: Morphine, Drug: Lidocaine* Day of 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients ≥18 years old
- Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
- No clinical or laboratory evidence of end organ failure:
- Platelets > 100 K/cumm
- Hemoglobin > 8.0 g/dl
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP | Drug | Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA) |
| MorphineAlso: Duramorph-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution) | Drug | Intrathecal morphine with intraoperative lidocaine infusion |
| Lidocaine-Lidocaine infusion 1 mg/kg ideal body weight (IBW) | Drug | Intrathecal morphine with intraoperative lidocaine infusion |
Primary outcome
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)
8 secondary outcomes
Rate of Postoperative Ileus
Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)
Length of Hospital Stay
Time frame: Estimated to be 4 days
Rate of Postoperative Hypotension
Time frame: Up to 48 hours after surgery
Patient Satisfaction With Pain Control
Time frame: Day of hospital discharge (estimated to be day 4)
Change in Pain Scores
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
Time frame: At 6 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premal H Thaker, M.D., MS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine, Morphine and Lidocaine in people with Cancer Debulking and Enlarged Uterus, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course (time frame: Postoperatively while patient is in hospital (estimated to be 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.