TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients: A Prospective Randomized Study.
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedResults Posted
Study results publicly available
January 18, 2016
CompletedMay 10, 2023
May 1, 2023
1.3 years
October 30, 2014
December 11, 2015
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Post Operative Opioid Use
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
0-72 hours after injection
Secondary Outcomes (3)
Numerical Rating Scale
48-72 hours
Post Operative Length of Stay
up to 30 days after surgery
Patient Satisfaction as Assessed Via Patient Survey
assessed at 72 hours after injection
Study Arms (2)
liposomal bupivacaine TAP
EXPERIMENTALthese patients receive a subcostal TAP with liposomal bupivacaine
bupivacaine TAP
ACTIVE COMPARATORThese patients receive a subcostal TAP with bupivacaine
Interventions
Eligibility Criteria
You may qualify if:
- those who present for elective robotic assisted hysterectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
PMID: 26056753DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jacob Hutchins
- Organization
- University of MInnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 13, 2014
Study Start
June 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 10, 2023
Results First Posted
January 18, 2016
Record last verified: 2023-05