| Primary | Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course | | | Posted | | Mean | Standard Deviation | mg | | Postoperatively while patient is in hospital (estimated to be 4 days) | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00089.9± 106.1
- OG00145.0± 89.8
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Two-sample t-test | | 0.0249 | | Mean Difference (Final Values) | -44.9 | | | 2-Sided | 95 | -84.0 | -5.8 | | | | | Superiority | | |
|
| 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. | | Posted | | Count of Participants | | Participants | | Postoperatively while patient is in hospital (estimated to be 4 days) | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
|
| Secondary | Length of Hospital Stay | Length of stay will be determined by the dates of admission as recorded in EPIC (days). | | Posted | | Mean | Standard Deviation | days | | Estimated to be 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |
| 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. | | Posted | | Count of Participants | | Participants | | Up to 48 hours after surgery | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |
| 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). | | Posted | | Count of Participants | | Participants | | Day of hospital discharge (estimated to be day 4) | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
|
| Secondary | 30 Day Readmission Rate | | | Posted | | Count of Participants | | Participants | | Through day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |
| Secondary | Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE) | | | Posted | | Count of Participants | | Participants | | From day of surgery (day 1) to 6 weeks after surgery | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |
| Secondary | Rate of Persistent Pain | -As determined by an NRS pain score ≥ 5 | Only participants who had the NRS Pain Score at 6 week follow-up are evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At 6 week follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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
| | OG001 | 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
|
| |