A Phase 4 interventional study of Bupivacaine and Fentanyl in Pain, Acute, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
Among 34 studies testing bupivacaine in Acute Pain — 5 open to participants now, 5 under way, none of them phase 3. Bupivacaine · Acute Pain.
Among the 34 studies testing bupivacaine in Acute Pain, this one is the 7th largest by enrollment, is one of 3 that started in 2016, is one of 22 in phase 4, and was the 11th registered.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 120 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →5 of the 34 studies testing bupivacaine in Acute Pain are open now, in 3 countries. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 101 Acute Pain studies recruiting now, 39 (39%) set no upper age limit and 49 (49%) stop at 75 or younger; 21 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2016.
Median enrollment 74 across the 34 interventional studies. Of the 24 that completed or were terminated, 12 (50%) have results posted.
1 of 34 have an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
University of California, San Francisco has 6 studies filed under Acute Pain — fewer than ten, so there is no comparison to draw.
2 of the studies testing bupivacaine in Acute Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07841951Medipol UniversityTwo Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy | 2027-05-30 |
| NCT07606911Shanghai Jiao Tong University Affiliated Sixth People's HospitalEffect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery. | 2027-07-01 |
Among the 34 studies testing bupivacaine in Acute Pain, from their registry updates:
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.
See brief summary
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.
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.
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.
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.
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.
Drug: Bupivacaine · Drug: Fentanyl
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.
Drug: Bupivacaine · Drug: Fentanyl
Also known as: 0.0625% bupivacaine
Also known as: 2mcg/ml fentanyl
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
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)
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)
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)
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)
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)
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)
Patients were enrolled between December 2016 to December 2018
| Milestone | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| Started | 60 | 60 |
| Completed | 46 | 53 |
| Not completed | 14 | 7 |
| Withdrew: Unplanned icu administrion | 5 | 3 |
| Withdrew: Aborted surgery | 1 | 2 |
| Withdrew: Hypotension | 6 | 0 |
| Withdrew: Nonfunctional epidural | 1 | 1 |
| Withdrew: Planned epidural removal | 1 | 0 |
| Withdrew: Intrathecal catheter placement | 0 | 1 |
Total local anesthetic consumed while epidural in place, recorded on infusion pump
| mg | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| Total Local Anesthetic Utilized in First 24 Hours | 126 (120 to 134) | 123 (115 to 136) |
Total opioid consumed (intravenous or po) while epidural in place
| MME | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| 24 hours postoperatively | 12 (0 to 28) | 16 (0 to 27) |
| 24 - 48 hours postoperatively | 0 (0 to 25) | 0 (0 to 30) |
| 48 - 72 hrs postoperatively | 0 (0 to 21) | 1 (0 to 18) |
Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
| score on a scale | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| 24 hours postoperatively | 9 (8 to 10) | 8 (6.5 to 10) |
| 24 - 48 hours postoperatively | 9 (7 to 10) | 9 (7.3 to 10) |
| 48 - 72 hours postoperatively | 9 (7 to 10) | 9 (8 to 10) |
Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
| units on a scale | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| 24 hours postoperatively | 3 (1 to 4) | 5 (2 to 5) |
| 24 - 48 hours postoperatively | 3 (1 to 4) | 2 (1 to 5) |
| 48 - 72 hours postoperatively | 3 (1 to 4) | 3 (1 to 4) |
Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
| Participants | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| Incidence of Hypotension | 9 | 18 |
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
| score on a scale | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| 24 hours postoperatively | 5 (2 to 7) | 8 (4 to 9) |
| 24 - 48 hours postoperatively | 6 (3 to 8) | 6 (3 to 8) |
| 48 - 72 hours postoperativley | 7 (5 to 8) | 6 (3 to 8) |
Minimum is 0, maximum is 10. 10 indicates highest pain interference.
| score on a scale | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| 24 hours postoperatively | 2 (0 to 4) | 3 (1 to 5) |
| 24 - 48 hours postoperatively | 1 (0 to 4) | 1 (0 to 4) |
| 48 - 72 hours postoperatively | 2 (0 to 4) | 1 (0 to 3) |
Collected over Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Epidural Infusion | 0/44 (0%) | 0/44 (0%) | 9/44 (20.5%) |
| Programmed Intermittent Epidural Bolus | 0/52 (0%) | 0/52 (0%) | 18/52 (34.6%) |
| Event | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus |
|---|---|---|
| HypotensionCardiac disorders | 9/44 | 18/52 |
| Age, Continuous(years) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Mean | 58 ± 14 | 55 ± 16 | 57 ± 15 |
| Sex: Female, Male(Participants) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Female | 42 | 43 | 85 |
| Male | 18 | 17 | 35 |
| Race/Ethnicity, Customized(Participants) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| White | 42 | 40 | 82 |
| Latinx | 7 | 9 | 16 |
| Black/African American | 0 | 1 | 1 |
| Asian/Pacific Islander | 11 | 10 | 21 |
| Home Medication Use(Participants) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Acetaminophen | 13 | 16 | 29 |
| NSAIDS | 14 | 11 | 25 |
| Gabapentinoids | 2 | 4 | 6 |
| TCA/SNRI | 0 | 0 | 0 |
| Daily opioid consumption(MME) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Median | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Pain Severity(units on a scale) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Current Pain | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Worst Pain | 2 (0 to 6) | 4 (0 to 7) | 3 (0 to 7) |
| Least Pain | 0 (0 to 1) | 0 (0 to 2) | 0 (0 to 1) |
| Average Pain | 1 (0 to 4) | 2 (0 to 4) | 1 (0 to 4) |
| Average Pain Interference(units on a scale) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Median | 1 (0 to 3) | 2 (0 to 6) | 1 (0 to 4) |
| World Health Organization Disability Assessment Schedule 2.0(units on a scale) | Continuous Epidural Infusion | Programmed Intermittent Epidural Bolus | Total |
|---|---|---|---|
| Mean | 12 (4 to 30) | 19 (12 to 32) | 17 (8 to 31) |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Bupivacaine · Fentanyl
University of California, San Francisco →