Phase 4
N=60
TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02289079 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Post Operative Opioid Use — 24.9; 51.7 micrograms of fentanyl equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); liposomal bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Opioid Use |
24.9; 51.7 | — |
| SECONDARY Numerical Rating Scale |
3; 5 | — |
| SECONDARY Post Operative Length of Stay |
11; 17 | — |
| SECONDARY Patient Satisfaction as Assessed Via Patient Survey |
26; 24 | — |
Summary
The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.
Eligibility Criteria
Inclusion Criteria
- those who present for elective robotic assisted hysterectomy
Exclusion Criteria
- non english speaking
- chronic pain
- on opioids greater than 1 weeks
- chronic anticoagulation
- allergy to local anesthetics
- use of spinal or epidural for surgery
- lack of patient cooperation
- contraindication to regional anesthesia
Data sourced from ClinicalTrials.gov (NCT02289079). 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.