Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03693404|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pertrochanteric Fracture||Drug: Marcaine, Duramorph , ketorolac Drug: Bupivacaine (Marcaine) Drug: General Anesthetics||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Spinal Anesthesia
Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Drug: Marcaine, Duramorph , ketorolac
Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Drug: Bupivacaine (Marcaine)
0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Active Comparator: General Anesthesia
The control group will receive no injection into area surrounding the fracture site
Drug: General Anesthetics
Placebo group will only receive standard of care general anesthesia
- amount (mg) of narcotics (oral morphine mg equivalents) used [ Time Frame: 6 Months ]Number of mgs taken of oral morphine
- duration of narcotic use [ Time Frame: 6 Months ]Number of days on morphine post surgery
- patient reported pain scores using VAS score [ Time Frame: 6 Months ]Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693404
|Contact: Rivka Ihejirika, MD||646 501 firstname.lastname@example.org|
|United States, New York|
|New York University Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Karan Patel 646-501-0291 email@example.com|
|Principal Investigator: Philip Leucht, MD|
|Principal Investigator:||Philipp Leucht, MD||NYU Langone Health|