Opioid Use, Pain, Postoperative
Conditions
Brief summary
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.
Interventions
DRUGBupivacaine
Bupivicaine injection into uterosacral ligaments prior to colpotomy
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to which arm they are in, surgeon will not as they will be performing injection however will not be assessing pain scores
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women over the age of 18 years old * undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital * Patients must be English speaking.
Exclusion criteria
* Pregnancy * allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs * pre-operative daily opioid consumption * peri-operative transverse abdominis plane block * recent history of drug or alcohol abuse (in last year) * severe cardiovascular, hepatic or renal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection | 7 days post-op | Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection | 7 days post-op | Patient will report VAS scores daily until post-op day 7 on a scale of 1-10 with higher scores indicating higher pain severity. The investigators will be looking for a statistically significant difference between the treatment and placebo vs. sham group. |
| Time to first bowel movement following uterosacral ligament bupivicaine injection | 7 days post-op | Patients will record when they resume normal bowel function on a pill diary post-operatively |
Countries
United States
Outcome results
None listed