Pain, Acute
Conditions
Brief summary
Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.
Detailed description
See brief summary
Interventions
DRUGBupivacaine
DRUGFentanyl
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment
Exclusion criteria
* Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score \> 5 each day for greater than 3 months, daily opioid consumption \> 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Local Anesthetic Utilized in First 24 Hours | In first 24 hours | Total local anesthetic consumed while epidural in place, recorded on infusion pump |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | While epidural in place (up to 72 hours postoperatively) | Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction. |
| Average Pain Severity | While epidural in place (up to 72 hours postoperatively) | Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity. |
| Total Opioid Consumed | While epidural in place (up to 72 hours post operatively) | Total opioid consumed (intravenous or po) while epidural in place |
| Worst Reported 24 Hour Pain | While epidural in place (up to 72 hours postoperatively) | Minimum is 0, maximum is 10. 10 indicates highest pain severity. |
| Average Pain Interference | While epidural in place (up to 72 hours postoperatively) | Minimum is 0, maximum is 10. 10 indicates highest pain interference. |
| Incidence of Hypotension | While epidural in place (24 hours postoperatively) | Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between December 2016 to December 2018
Pre-assignment details
Patients were not randomized to study groups if epidurals were not able to be successfully placed. 2 subjects in the CEI group were no included in the analysis due to missing data 1 subject in the PIEB group was not included in the analysis due to missing data
Participants by arm
| Arm | Count |
|---|---|
| Continuous Epidural Infusion At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl | 60 |
| Programmed Intermittent Epidural Bolus For the programmed intermittent epidural bolus group:
Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.
Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Bupivacaine
Fentanyl | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Aborted Surgery | 1 | 2 |
| Overall Study | Hypotension | 6 | 0 |
| Overall Study | Intrathecal catheter placement | 0 | 1 |
| Overall Study | Nonfunctional epidural | 1 | 1 |
| Overall Study | Planned epidural removal | 1 | 0 |
| Overall Study | Unplanned ICU Administrion | 5 | 3 |
Baseline characteristics
| Characteristic | Total | Programmed Intermittent Epidural Bolus | Continuous Epidural Infusion |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 16 | 58 years STANDARD_DEVIATION 14 |
| Average Pain Interference | 1 units on a scale | 2 units on a scale | 1 units on a scale |
| Daily opioid consumption | 0 MME | 0 MME | 0 MME |
| Depression HADS Score Mild | 15 Participants | 11 Participants | 4 Participants |
| Depression HADS Score Moderate | 8 Participants | 3 Participants | 5 Participants |
| Depression HADS Score None | 95 Participants | 45 Participants | 50 Participants |
| Depression HADS Score Severe | 1 Participants | 0 Participants | 1 Participants |
| HADS Anxiety Score Mild | 28 Participants | 14 Participants | 14 Participants |
| HADS Anxiety Score Moderate | 16 Participants | 9 Participants | 7 Participants |
| HADS Anxiety Score None | 69 Participants | 34 Participants | 35 Participants |
| HADS Anxiety Score Severe | 6 Participants | 2 Participants | 4 Participants |
| Home Medication Use Acetaminophen | 29 Participants | 16 Participants | 13 Participants |
| Home Medication Use Gabapentinoids | 6 Participants | 4 Participants | 2 Participants |
| Home Medication Use NSAIDS | 25 Participants | 11 Participants | 14 Participants |
| Home Medication Use TCA/SNRI | 0 Participants | 0 Participants | 0 Participants |
| Intraoperative Opioids | 39 MME | 44 MME | 38 MME |
| Length of Epidural Therapy | 2 Days | 2 Days | 2 Days |
| Pain Severity Average Pain | 1 units on a scale | 2 units on a scale | 1 units on a scale |
| Pain Severity Current Pain | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Pain Severity Least Pain | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Pain Severity Worst Pain | 3 units on a scale | 4 units on a scale | 2 units on a scale |
| Race/Ethnicity, Customized Asian/Pacific Islander | 21 Participants | 10 Participants | 11 Participants |
| Race/Ethnicity, Customized Black/African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Latinx | 16 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 82 Participants | 40 Participants | 42 Participants |
| Sex: Female, Male Female | 85 Participants | 43 Participants | 42 Participants |
| Sex: Female, Male Male | 35 Participants | 17 Participants | 18 Participants |
| Type of Surgery Gynecologic | 42 Participants | 21 Participants | 21 Participants |
| Type of Surgery Hepatobiliary | 32 Participants | 19 Participants | 13 Participants |
| Type of Surgery Lower GI (colorectal) | 35 Participants | 17 Participants | 18 Participants |
| Type of Surgery Upper GI (gastric, small intestine) | 11 Participants | 3 Participants | 8 Participants |
| World Health Organization Disability Assessment Schedule 2.0 | 17 units on a scale | 19 units on a scale | 12 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 52 |
| other Total, other adverse events | 9 / 44 | 18 / 52 |
| serious Total, serious adverse events | 0 / 44 | 0 / 52 |
Outcome results
Primary
Total Local Anesthetic Utilized in First 24 Hours
Total local anesthetic consumed while epidural in place, recorded on infusion pump
Time frame: In first 24 hours
Population: Note that 2 patients in the CEI group and 1 patient in the PIEB group was not included in the analysis due to missing data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Epidural Infusion | Total Local Anesthetic Utilized in First 24 Hours | 126 mg |
| Programmed Intermittent Epidural Bolus | Total Local Anesthetic Utilized in First 24 Hours | 123 mg |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Average Pain Interference
Minimum is 0, maximum is 10. 10 indicates highest pain interference.
Time frame: While epidural in place (up to 72 hours postoperatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Epidural Infusion | Average Pain Interference | 24 hours postoperatively | 2 score on a scale |
| Continuous Epidural Infusion | Average Pain Interference | 24 - 48 hours postoperatively | 1 score on a scale |
| Continuous Epidural Infusion | Average Pain Interference | 48 - 72 hours postoperatively | 2 score on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Interference | 24 hours postoperatively | 3 score on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Interference | 24 - 48 hours postoperatively | 1 score on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Interference | 48 - 72 hours postoperatively | 1 score on a scale |
Secondary
Average Pain Severity
Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Time frame: While epidural in place (up to 72 hours postoperatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Epidural Infusion | Average Pain Severity | 24 - 48 hours postoperatively | 3 units on a scale |
| Continuous Epidural Infusion | Average Pain Severity | 24 hours postoperatively | 3 units on a scale |
| Continuous Epidural Infusion | Average Pain Severity | 48 - 72 hours postoperatively | 3 units on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Severity | 24 hours postoperatively | 5 units on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Severity | 24 - 48 hours postoperatively | 2 units on a scale |
| Programmed Intermittent Epidural Bolus | Average Pain Severity | 48 - 72 hours postoperatively | 3 units on a scale |
Secondary
Incidence of Hypotension
Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
Time frame: While epidural in place (24 hours postoperatively)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Epidural Infusion | Incidence of Hypotension | 9 Participants |
| Programmed Intermittent Epidural Bolus | Incidence of Hypotension | 18 Participants |
Secondary
Patient Satisfaction Score
Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
Time frame: While epidural in place (up to 72 hours postoperatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Epidural Infusion | Patient Satisfaction Score | 24 hours postoperatively | 9 score on a scale |
| Continuous Epidural Infusion | Patient Satisfaction Score | 24 - 48 hours postoperatively | 9 score on a scale |
| Continuous Epidural Infusion | Patient Satisfaction Score | 48 - 72 hours postoperatively | 9 score on a scale |
| Programmed Intermittent Epidural Bolus | Patient Satisfaction Score | 24 hours postoperatively | 8 score on a scale |
| Programmed Intermittent Epidural Bolus | Patient Satisfaction Score | 24 - 48 hours postoperatively | 9 score on a scale |
| Programmed Intermittent Epidural Bolus | Patient Satisfaction Score | 48 - 72 hours postoperatively | 9 score on a scale |
Secondary
Total Opioid Consumed
Total opioid consumed (intravenous or po) while epidural in place
Time frame: While epidural in place (up to 72 hours post operatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Epidural Infusion | Total Opioid Consumed | 24 - 48 hours postoperatively | 0 MME |
| Continuous Epidural Infusion | Total Opioid Consumed | 24 hours postoperatively | 12 MME |
| Continuous Epidural Infusion | Total Opioid Consumed | 48 - 72 hrs postoperatively | 0 MME |
| Programmed Intermittent Epidural Bolus | Total Opioid Consumed | 24 hours postoperatively | 16 MME |
| Programmed Intermittent Epidural Bolus | Total Opioid Consumed | 24 - 48 hours postoperatively | 0 MME |
| Programmed Intermittent Epidural Bolus | Total Opioid Consumed | 48 - 72 hrs postoperatively | 1 MME |
Secondary
Worst Reported 24 Hour Pain
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Time frame: While epidural in place (up to 72 hours postoperatively)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Epidural Infusion | Worst Reported 24 Hour Pain | 24 hours postoperatively | 5 score on a scale |
| Continuous Epidural Infusion | Worst Reported 24 Hour Pain | 24 - 48 hours postoperatively | 6 score on a scale |
| Continuous Epidural Infusion | Worst Reported 24 Hour Pain | 48 - 72 hours postoperativley | 7 score on a scale |
| Programmed Intermittent Epidural Bolus | Worst Reported 24 Hour Pain | 24 hours postoperatively | 8 score on a scale |
| Programmed Intermittent Epidural Bolus | Worst Reported 24 Hour Pain | 24 - 48 hours postoperatively | 6 score on a scale |
| Programmed Intermittent Epidural Bolus | Worst Reported 24 Hour Pain | 48 - 72 hours postoperativley | 6 score on a scale |