Pain, Acute Clinical Trial
Official title:
A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
Verified date | April 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 28, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Local Anesthetic Utilized in First 24 Hours | Total local anesthetic consumed while epidural in place, recorded on infusion pump | In first 24 hours | |
Secondary | Total Opioid Consumed | Total opioid consumed (intravenous or po) while epidural in place | While epidural in place (up to 72 hours post operatively) | |
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. |
While epidural in place (up to 72 hours postoperatively) | |
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. | While epidural in place (up to 72 hours postoperatively) | |
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. | While epidural in place (24 hours postoperatively) | |
Secondary | Worst Reported 24 Hour Pain | Minimum is 0, maximum is 10. 10 indicates highest pain severity. | While epidural in place (up to 72 hours postoperatively) | |
Secondary | Average Pain Interference | Minimum is 0, maximum is 10. 10 indicates highest pain interference. | While epidural in place (up to 72 hours postoperatively) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05396820 -
Adaptation of the Motor System to Experimental Pain
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Recruiting |
NCT06350084 -
Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05458037 -
RCT of Pain Perception With Fast and Slow Tenaculum Application
|
N/A | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Completed |
NCT06005480 -
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT04850079 -
EHR Precision Drug Treatment in Neonates
|
||
Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
Recruiting |
NCT05383820 -
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
|
Phase 4 | |
Completed |
NCT04851353 -
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
|
N/A | |
Completed |
NCT03280017 -
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
|
Phase 4 | |
Completed |
NCT04280796 -
Changes in Affective Pain Processing in Human Volunteers
|
N/A | |
Not yet recruiting |
NCT04523623 -
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
|
N/A | |
Not yet recruiting |
NCT04491630 -
COping With PAin Through Hypnosis, Mindfulness and Spirituality
|
N/A | |
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Withdrawn |
NCT03137017 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
|
Phase 1 | |
Withdrawn |
NCT03137030 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
|
Phase 1 | |
Completed |
NCT04659395 -
How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block
|
N/A |