Phase 3
N=45
Bupivacaine With Epidural Volume Extension
Spinal Anesthesia · Epidural; Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03110003 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Time Until PACU Discharge in Minutes — 135; 50 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 10 mg Bupivacaine (Drug); 5 mg Bupivacaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Until PACU Discharge in Minutes |
135; 50 | — |
| SECONDARY Peak Block Height |
5; 5 | — |
| SECONDARY Degree of Peak Motor Blockade by Modified Bromage Scale |
3; 3 | — |
| SECONDARY Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0 |
181; 66 | — |
| SECONDARY Quality of Block as Determined by Subjective Pain Assessment |
— | — |
| SECONDARY Patient Satisfaction as Determined by a Likert-type Scale |
— | — |
Summary
In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.
Exclusion Criteria
- coagulopathy
- platelets <80,000
- allergy to local anesthetic or fentanyl
- previous spinal surgery
- spinal or intracranial mass
- history of lower extremity weakness
Data sourced from ClinicalTrials.gov (NCT03110003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.