A Phase 2 interventional study of Bupivacaine and Morphine in Cancer Debulking, Enlarged Uterus and Fibroid Uterus, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Supportive care
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).
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's enrollment of 110 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If available:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
* 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
Drug: Morphine · Drug: Lidocaine
-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
Also known as: Duramorph
-Lidocaine infusion 1 mg/kg ideal body weight (IBW)
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
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
-As determined by an NRS pain score ≥ 5
Time frame: At 6 week follow-up
| Milestone | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Started | 56 | 54 |
| Completed | 50 | 46 |
| Not completed | 6 | 8 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Determined to be ineligible | 0 | 1 |
| Withdrew: Withdrawn due to patient being given heparin | 0 | 1 |
| Withdrew: Technical failure | 1 | 3 |
| mg | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course | 89.9 ± 106.1 | 45.0 ± 89.8 |
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.
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Rate of Postoperative Ileus | 6 | 6 |
Length of stay will be determined by the dates of admission as recorded in EPIC (days).
| days | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Length of Hospital Stay | 4.7 ± 2.0 | 4.4 ± 1.8 |
-Postoperative hypotension will be defined as \<90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Rate of Postoperative Hypotension | 23 | 21 |
-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).
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Very satisfied | 41 | 42 |
| A little satisfied | 8 | 5 |
| Not sure | 0 | 2 |
| A little dissatisfied | 1 | 0 |
| Very dissatisfied | 1 | 0 |
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.
| score on a scale | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Preoperative | 1.7 ± 2.3 | 1.7 ± 2.2 |
| Day of surgery | 3.7 ± 2.1 | 2.0 ± 1.8 |
| Post-operative day 1 | 3.7 ± 2.3 | 3.0 ± 2.1 |
| Post-operative day 2 | 3.7 ± 2.4 | 3.3 ± 2.1 |
| Post-operative day 3 | 3.3 ± 2.3 | 2.8 ± 1.9 |
| Post-operative day 4 | 3.3 ± 2.3 | 2.9 ± 1.9 |
| Post-operative day 5 | 3.0 ± 2.7 | 2.6 ± 2.3 |
| Post-operative day 6 | 2.5 ± 1.9 | 2.3 ± 2.8 |
| Post-operative day 7 | 1.9 ± 2.1 | 2.0 ± 3.6 |
| Post-operative day 8 | 2.1 ± 2.5 | 3.3 ± 4.6 |
| Post-operative day 9 | 4.8 | 3.3 ± 3.9 |
| 2 week follow-up | 1.9 ± 1.8 | 1.6 ± 1.7 |
| 6 week follow-up | 0.85 ± 1.5 | 0.76 ± 1.7 |
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| 30 Day Readmission Rate | 2 | 3 |
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE) | 1 | 2 |
-As determined by an NRS pain score ≥ 5
| Participants | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| Rate of Persistent Pain | 3 | 2 |
Collected over Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | 0/51 (0%) | 6/51 (11.8%) | 36/51 (70.6%) |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | 2/49 (4.1%) | 4/49 (8.2%) | 41/49 (83.7%) |
| Event | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| HypotensionVascular disorders | 0/51 | 2/49 |
| HypovolemiaBlood and lymphatic system disorders | 0/51 | 1/49 |
| Abdominal painGastrointestinal disorders | 0/51 | 1/49 |
| Death due to endometrial cancerGeneral disorders | 0/51 | 1/49 |
| Generalized edemaGeneral disorders | 0/51 | 1/49 |
| Adult respiratory distressRespiratory, thoracic and mediastinal disorders | 1/51 | 1/49 |
| BradypneaRespiratory, thoracic and mediastinal disorders | 0/51 | 1/49 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/51 | 1/49 |
| Acute blood loss anemiaBlood and lymphatic system disorders | 1/51 | 0/49 |
| Atrial fibrillationCardiac disorders | 1/51 | 0/49 |
| Event | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|
| HypotensionVascular disorders | 22/51 | 19/49 |
| Creatinine increasedInvestigations | 10/51 | 0/49 |
| AnemiaBlood and lymphatic system disorders | 6/51 | 8/49 |
| Acute kidney injuryRenal and urinary disorders | 0/51 | 8/49 |
| IleusGastrointestinal disorders | 6/51 | 6/49 |
| HyponatremiaMetabolism and nutrition disorders | 1/51 | 3/49 |
| Thromboembolic eventVascular disorders | 0/51 | 3/49 |
| Urine output decreasedRenal and urinary disorders | 1/51 | 2/49 |
| HypertensionVascular disorders | 1/51 | 2/49 |
| HypocalcemiaMetabolism and nutrition disorders | 2/51 | 1/49 |
| Age, Continuous(years) | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion | Total |
|---|---|---|---|
| Median | 60 (23 to 82) | 64 (24 to 84) | 60 (23 to 84) |
| Sex: Female, Male(Participants) | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion | Total |
|---|---|---|---|
| Female | 56 | 54 | 110 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 55 | 53 | 108 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 7 | 6 | 13 |
| White | 44 | 45 | 89 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Intrathecal Morphine With Intraoperative Lidocaine Infusion | Total |
|---|---|---|---|
| United States | 56 | 54 | 110 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Morphine · Lidocaine
Washington University School of Medicine →