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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No injection | Placebo Comparator | No injection will be performed |
|
| Normal Saline Injection | Sham Comparator | Normal saline will be injected into the uterosacral ligaments prior to colpotomy |
|
| Bupivacaine Injection | Active Comparator | Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivicaine injection into uterosacral ligaments prior to colpotomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Wang | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Howard County General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37531986 | Derived | Frost AS, Kohn JR, Le Neveu M, Brah T, Okonkwo O, Borahay MA, Wu H, Simpson K, Patzkowsky KE, Wang KC. Laparoscopic administration of bupivacaine at the uterosacral ligaments during benign laparoscopic and robotic hysterectomy: a randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):526.e1-526.e14. doi: 10.1016/j.ajog.2023.07.047. Epub 2023 Jul 31. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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
| 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 |
| Columbia |
| Maryland |
| 21044 |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |