Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02289079 |
Other study ID # |
1305m34041 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
June 2013 |
Est. completion date |
October 2014 |
Study information
Verified date |
May 2023 |
Source |
University of Minnesota |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.