Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Avanos Medical | OTHER |
Not provided
Not provided
Not provided
The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Subjects will receive a continuous intraperitoneal infusion of ropivacaine |
|
| Ropivacaine + Ketorolac | Experimental | Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac |
|
| Normal Saline | Placebo Comparator | Subjects will receive a continuous intraperitoneal infusion of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine Infusion from ON-Q Pump | Drug | Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level 1 Hour Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 1 hour postoperative |
| Pain Level 2 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 2 hours postoperative |
| Pain Level 4 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 4 hours postoperative |
| Pain Level 6 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 6 hours postoperative |
| Pain Level 24 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 24 hours postoperative |
| Pain Level 48 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 48 hours postoperative |
| Pain Level 72 Hours Postoperative | Rating from 0 "No pain sensation" to 10 "most intense pain imaginable" | 72 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The total dose of analgesics taken over the 72 postoperative hours | Each of the following was considered to be one dose: 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol | Within 72 hours postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radwa Aly | Contact | 202 677 6209 | raly@mfa.gwu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Keller, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
Not provided
Not provided
Not provided
Not provided
This is a double-blind study; the surgeon and the patient will not know which study group they are a part of. Only the IDS pharmacist and IDS pharmacy technician will know which group each study patient has been assigned to.
| Ropivacaine + Ketorolac Infusion from ON-Q Pump | Drug | Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours |
|
|
| Normal Saline Infusion from ON-Q Pump | Drug | Infusion of 0.9% normal saline at 8 mL/hour for 72 hours |
|
|
| The GW Medical Faculty Associates | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020911 | Ketorolac Tromethamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided