TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bupivacaine
liposomal bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
liposomal bupivacaine TAP
bupivacaine TAP
Arm Description
these patients receive a subcostal TAP with liposomal bupivacaine
These patients receive a subcostal TAP with bupivacaine
Outcomes
Primary Outcome Measures
Post Operative Opioid Use
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
Secondary Outcome Measures
Numerical Rating Scale
This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.
Post Operative Length of Stay
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
Patient Satisfaction as Assessed Via Patient Survey
To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02289079
Brief Title
TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
Official Title
Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients: A Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Treatment technique:
The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.
When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score.
If patients have met criterion for discharge to home including pain <4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement.
If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred.
Adequate analgesia will be defined as <3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liposomal bupivacaine TAP
Arm Type
Experimental
Arm Description
these patients receive a subcostal TAP with liposomal bupivacaine
Arm Title
bupivacaine TAP
Arm Type
Active Comparator
Arm Description
These patients receive a subcostal TAP with bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Drug
Intervention Name(s)
liposomal bupivacaine
Primary Outcome Measure Information:
Title
Post Operative Opioid Use
Description
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
Time Frame
0-72 hours after injection
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.
Time Frame
48-72 hours
Title
Post Operative Length of Stay
Description
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
Time Frame
up to 30 days after surgery
Title
Patient Satisfaction as Assessed Via Patient Survey
Description
To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
Time Frame
assessed at 72 hours after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26056753
Citation
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.
Results Reference
derived
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TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
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