Adnexal Mass, Cancer Debulking, Enlarged Uterus, Fibroid Uterus
Conditions
Keywords
ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus
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).
Interventions
DRUGBupivacaine
-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
DRUGMorphine
-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
DRUGLidocaine
-Lidocaine infusion 1 mg/kg ideal body weight (IBW)
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course | Postoperatively while patient is in hospital (estimated to be 4 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Estimated to be 4 days | Length of stay will be determined by the dates of admission as recorded in EPIC (days). |
| Rate of Postoperative Hypotension | Up to 48 hours after surgery | -Postoperative hypotension will be defined as \<90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit. |
| Patient Satisfaction With Pain Control | Day of hospital discharge (estimated to be day 4) | -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). |
| Rate of Postoperative Ileus | Postoperatively while patient is in hospital (estimated to be 4 days) | 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. |
| 30 Day Readmission Rate | Through day 30 | — |
| Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE) | From day of surgery (day 1) to 6 weeks after surgery | — |
| Rate of Persistent Pain | At 6 week follow-up | -As determined by an NRS pain score ≥ 5 |
| Change in Pain Scores | Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) * 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 | 56 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion * 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 | 54 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Determined to be ineligible | 0 | 1 |
| Overall Study | Technical failure | 1 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
| Overall Study | Withdrawn due to patient being given heparin | 0 | 1 |
Baseline characteristics
| Characteristic | Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Total | Intrathecal Morphine With Intraoperative Lidocaine Infusion |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 108 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 89 Participants | 45 Participants |
| Region of Enrollment United States | 56 participants | 110 participants | 54 participants |
| Sex: Female, Male Female | 56 Participants | 110 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 2 / 49 |
| other Total, other adverse events | 36 / 51 | 41 / 49 |
| serious Total, serious adverse events | 6 / 51 | 4 / 49 |
Outcome results
Primary
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course | 89.9 mg | Standard Deviation 106.1 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course | 45.0 mg | Standard Deviation 89.8 |
p-value: 0.024995% CI: [-84, -5.8]Two-sample t-test
Secondary
30 Day Readmission Rate
Time frame: Through day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | 30 Day Readmission Rate | 2 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | 30 Day Readmission Rate | 3 Participants |
p-value: 0.6795% CI: [0.27, 8.95]Fisher Exact
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. A higher score indicates more pain.
Time frame: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
Population: The number analyzed at the different time points may be different than the overall number analyzed due to participant not being hospitalized at the time point or the pain score not being completed at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Preoperative | 1.7 score on a scale | Standard Deviation 2.3 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 5 | 3.0 score on a scale | Standard Deviation 2.7 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 1 | 3.7 score on a scale | Standard Deviation 2.3 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 6 | 2.5 score on a scale | Standard Deviation 1.9 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 2 | 3.7 score on a scale | Standard Deviation 2.4 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 8 | 2.1 score on a scale | Standard Deviation 2.5 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 3 | 3.3 score on a scale | Standard Deviation 2.3 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 9 | 4.8 score on a scale | — |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Day of surgery | 3.7 score on a scale | Standard Deviation 2.1 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | 2 week follow-up | 1.9 score on a scale | Standard Deviation 1.8 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 4 | 3.3 score on a scale | Standard Deviation 2.3 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | 6 week follow-up | 0.85 score on a scale | Standard Deviation 1.5 |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Change in Pain Scores | Post-operative day 7 | 1.9 score on a scale | Standard Deviation 2.1 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | 6 week follow-up | 0.76 score on a scale | Standard Deviation 1.7 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 7 | 2.0 score on a scale | Standard Deviation 3.6 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 1 | 3.0 score on a scale | Standard Deviation 2.1 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Preoperative | 1.7 score on a scale | Standard Deviation 2.2 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Day of surgery | 2.0 score on a scale | Standard Deviation 1.8 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 2 | 3.3 score on a scale | Standard Deviation 2.1 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 3 | 2.8 score on a scale | Standard Deviation 1.9 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 4 | 2.9 score on a scale | Standard Deviation 1.9 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 5 | 2.6 score on a scale | Standard Deviation 2.3 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 6 | 2.3 score on a scale | Standard Deviation 2.8 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 8 | 3.3 score on a scale | Standard Deviation 4.6 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | Post-operative day 9 | 3.3 score on a scale | Standard Deviation 3.9 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Change in Pain Scores | 2 week follow-up | 1.6 score on a scale | Standard Deviation 1.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Length of Hospital Stay | 4.7 days | Standard Deviation 2 |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Length of Hospital Stay | 4.4 days | Standard Deviation 1.8 |
p-value: 0.5995% CI: [-1.01, 0.48]Bootstrap resampling method
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).
Time frame: Day of hospital discharge (estimated to be day 4)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Patient Satisfaction With Pain Control | A little satisfied | 8 Participants |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Patient Satisfaction With Pain Control | A little dissatisfied | 1 Participants |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Patient Satisfaction With Pain Control | Not sure | 0 Participants |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Patient Satisfaction With Pain Control | Very dissatisfied | 1 Participants |
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Patient Satisfaction With Pain Control | Very satisfied | 41 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Patient Satisfaction With Pain Control | Very dissatisfied | 0 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Patient Satisfaction With Pain Control | Very satisfied | 42 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Patient Satisfaction With Pain Control | A little satisfied | 5 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Patient Satisfaction With Pain Control | Not sure | 2 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Patient Satisfaction With Pain Control | A little dissatisfied | 0 Participants |
Secondary
Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)
Time frame: From day of surgery (day 1) to 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE) | 1 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE) | 2 Participants |
p-value: 0.6195% CI: [0.19, 22.2]Fisher Exact
Secondary
Rate of Persistent Pain
-As determined by an NRS pain score ≥ 5
Time frame: At 6 week follow-up
Population: Only participants who had the NRS Pain Score at 6 week follow-up are evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Rate of Persistent Pain | 3 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Rate of Persistent Pain | 2 Participants |
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.
Time frame: Up to 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Rate of Postoperative Hypotension | 23 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Rate of Postoperative Hypotension | 21 Participants |
p-value: 0.8295% CI: [0.61, 1.48]Chi-squared
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.
Time frame: Postoperatively while patient is in hospital (estimated to be 4 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) | Rate of Postoperative Ileus | 6 Participants |
| Intrathecal Morphine With Intraoperative Lidocaine Infusion | Rate of Postoperative Ileus | 6 Participants |
p-value: 0.9495% CI: [0.36, 3.01]Chi-squared