Trial Outcomes & Findings for Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy (NCT NCT05017246)
NCT ID: NCT05017246
Last Updated: 2025-07-31
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Postoperatively while patient is in hospital (estimated to be 4 days)
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
50
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Determined to be ineligible
|
0
|
1
|
|
Overall Study
Withdrawn due to patient being given heparin
|
0
|
1
|
|
Overall Study
Technical failure
|
1
|
3
|
Baseline Characteristics
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Baseline characteristics by cohort
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=56 Participants
* 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
n=54 Participants
* 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
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
64 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperatively while patient is in hospital (estimated to be 4 days)Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
|
89.9 mg
Standard Deviation 106.1
|
45.0 mg
Standard Deviation 89.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Rate of Postoperative Ileus
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Estimated to be 4 daysLength of stay will be determined by the dates of admission as recorded in EPIC (days).
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Length of Hospital Stay
|
4.7 days
Standard Deviation 2.0
|
4.4 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Rate of Postoperative Hypotension
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Patient Satisfaction With Pain Control
Very satisfied
|
41 Participants
|
42 Participants
|
|
Patient Satisfaction With Pain Control
A little satisfied
|
8 Participants
|
5 Participants
|
|
Patient Satisfaction With Pain Control
Not sure
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Pain Control
A little dissatisfied
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Pain Control
Very dissatisfied
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Change in Pain Scores
Preoperative
|
1.7 score on a scale
Standard Deviation 2.3
|
1.7 score on a scale
Standard Deviation 2.2
|
|
Change in Pain Scores
Day of surgery
|
3.7 score on a scale
Standard Deviation 2.1
|
2.0 score on a scale
Standard Deviation 1.8
|
|
Change in Pain Scores
Post-operative day 1
|
3.7 score on a scale
Standard Deviation 2.3
|
3.0 score on a scale
Standard Deviation 2.1
|
|
Change in Pain Scores
Post-operative day 2
|
3.7 score on a scale
Standard Deviation 2.4
|
3.3 score on a scale
Standard Deviation 2.1
|
|
Change in Pain Scores
Post-operative day 3
|
3.3 score on a scale
Standard Deviation 2.3
|
2.8 score on a scale
Standard Deviation 1.9
|
|
Change in Pain Scores
Post-operative day 4
|
3.3 score on a scale
Standard Deviation 2.3
|
2.9 score on a scale
Standard Deviation 1.9
|
|
Change in Pain Scores
Post-operative day 5
|
3.0 score on a scale
Standard Deviation 2.7
|
2.6 score on a scale
Standard Deviation 2.3
|
|
Change in Pain Scores
Post-operative day 6
|
2.5 score on a scale
Standard Deviation 1.9
|
2.3 score on a scale
Standard Deviation 2.8
|
|
Change in Pain Scores
Post-operative day 7
|
1.9 score on a scale
Standard Deviation 2.1
|
2.0 score on a scale
Standard Deviation 3.6
|
|
Change in Pain Scores
Post-operative day 8
|
2.1 score on a scale
Standard Deviation 2.5
|
3.3 score on a scale
Standard Deviation 4.6
|
|
Change in Pain Scores
Post-operative day 9
|
4.8 score on a scale
|
3.3 score on a scale
Standard Deviation 3.9
|
|
Change in Pain Scores
2 week follow-up
|
1.9 score on a scale
Standard Deviation 1.8
|
1.6 score on a scale
Standard Deviation 1.7
|
|
Change in Pain Scores
6 week follow-up
|
0.85 score on a scale
Standard Deviation 1.5
|
0.76 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Through day 30Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
30 Day Readmission Rate
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From day of surgery (day 1) to 6 weeks after surgeryOutcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 Participants
* 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
n=49 Participants
* 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
|
|---|---|---|
|
Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 6 week follow-upPopulation: Only participants who had the NRS Pain Score at 6 week follow-up are evaluable for this outcome measure.
-As determined by an NRS pain score ≥ 5
Outcome measures
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=46 Participants
* 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
n=45 Participants
* 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
|
|---|---|---|
|
Rate of Persistent Pain
|
3 Participants
|
2 Participants
|
Adverse Events
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Intrathecal Morphine With Intraoperative Lidocaine Infusion
Serious events: 4 serious events
Other events: 41 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 participants at risk
* 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
n=49 participants at risk
* 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
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Blood and lymphatic system disorders
Hypovolemia
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
General disorders
Death due to endometrial cancer
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
General disorders
Generalized edema
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnea
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Surgical and medical procedures
Surgery (exploratory laparotomy/large bowel resection/end colostomy/mucous fistula procedure)
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Vascular disorders
Hypotension
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
4.1%
2/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
Other adverse events
| Measure |
Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA)
n=51 participants at risk
* 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
n=49 participants at risk
* 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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
6/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
16.3%
8/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Ileus
|
11.8%
6/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
12.2%
6/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
General disorders
Fever
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Infections and infestations
Lung infection
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Injury, poisoning and procedural complications
Intestinal stoma obstruction
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Injury, poisoning and procedural complications
Seroma
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Investigations
Creatinine increased
|
19.6%
10/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.9%
2/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
6.1%
3/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Psychiatric disorders
Delirium
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
16.3%
8/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Renal and urinary disorders
Prerenal acute kidney injury
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Renal and urinary disorders
Urine output decreased
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
4.1%
2/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Delayed awakening
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
0.00%
0/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
2.0%
1/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
4.1%
2/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Vascular disorders
Hypotension
|
43.1%
22/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
38.8%
19/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/51 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
6.1%
3/49 • Adverse events and all-cause mortality were collected from day of surgery through 6-week follow-up.
|
Additional Information
Dr. Premal H Thaker
Washington University School of Medicine
Phone: 314-747-3604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place