Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Study Overview
=================
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.

Official Title
-----------------
The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy

Conditions
-----------------
Pain, Postoperative, Opioid Use

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No injection<br>No injection will be performed | Drug: Bupivacaine<br>* Bupivicaine injection into uterosacral ligaments prior to colpotomy<br>|
| Sham Comparator: Normal Saline Injection<br>Normal saline will be injected into the uterosacral ligaments prior to colpotomy | Drug: Bupivacaine<br>* Bupivicaine injection into uterosacral ligaments prior to colpotomy<br>|
| Active Comparator: Bupivacaine Injection<br>Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy | Drug: Bupivacaine<br>* Bupivicaine injection into uterosacral ligaments prior to colpotomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection | Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference | 7 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection | 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. | 7 days post-op | 
| Time to first bowel movement following uterosacral ligament bupivicaine injection | Patients will record when they resume normal bowel function on a pill diary post-operatively | 7 days post-op |