Pain, Postoperative
Conditions
Keywords
elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH), Total Laparoscopic Hysterectomy (TLH), Benign
Brief summary
The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.
Interventions
DRUGCombined Bupivacaine and Exparel
In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.
In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 66.5kg weight * elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights.
Exclusion criteria
* Combined operation or alternative approach * inpatient overnight admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain as assessed by the visual analog scale (VAS) | 4-6 hours post operation, postoperative day 1, postoperative day 3 | Pain will be scored from 1-10 , higher number indicating more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed | 2-week and 6- week follow up | — |
| Change in level of pain control achieved as assessed by the frequency of NSAIDS needed | 2-week and 6- week follow up | — |
| Change in level of pain control achieved as assessed by the amount of opioids needed | 2-week and 6- week follow up | — |
| Change in level of pain control achieved as assessed by the frequency of opioids needed | 2-week and 6- week follow up | — |
| Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon | 2-week and 6- week follow up | — |
| Change in presence of vaginal dehiscence | 2-week and 6- week follow up | This will be categorically reported as a yes or no answer |
Countries
United States
Contacts
CONTACTAsha B Bhalwal, MD
CONTACTAya Sasson Mohr
PRINCIPAL_INVESTIGATORAsha B Bhalwal, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed