Gabapentin Premedication for ACL Reconstruction: RCT
|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: NCT03417479|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment|
|Anterior Cruciate Ligament (ACL) Reconstruction||Other: Gabapentin|
Anterior Cruciate Ligament (ACL) injury and surgical repair occurs in 200,000 active adolescent and young adult patients each year. ACL repair is associated with significant postoperative pain. Current methodologies for pain include regional nerve blocks, opioid or non-steroidal analgesia. Few studies have evaluated use of neuro-inhibitors such as gabapentin to limit pain response.
The purpose of this study then is to examine the use of gabapentin in reducing postoperative pain in adolescent ACL patients. The investigators hypothesize one 15mg/kg (up to 600mg) dose of gabapentin preoperatively would reduce: 1) self-reported postoperative pain and, 2) opioid use compared to patients who do not receive preoperative gabapentin.
This double blind randomized control trial will enroll 100 participants ages 12-18 years, undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse obtained from the EMR and participant interviews with a phone nurse for five days postoperatively to determine severity of pain as well as use of opioids.
Outcome measurements will give a more comprehensive description of the postoperative experience and test gabapentin's opioid sparing effect. Due to paucity of literature on pain relief in this population, this pilot study will inform a larger multi-site study.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial|
|Actual Study Start Date :||October 9, 2015|
|Actual Primary Completion Date :||June 6, 2018|
|Estimated Study Completion Date :||September 1, 2018|
Patients will be randomized to either a single dose of 15mg/kg up to 600 mg of gabapentin or a placebo equivalent at a 1:1 ratio. The subjects will be enrolled in the study at the orthopedic surgeon's office with randomization occurring on the day of surgery by the hospital pharmacist. The method for the randomization will be the creation of a sequence of sealed envelopes containing assignment information for a dose of 600 mg of gabapentin or placebo.
Other Name: Neurontin
- Effective Dose determination [ Time Frame: 5 days post surgery ]To determine whether one 15mg/kg (up to 600 mg) dose of gabapentin preoperatively reduces pain after ACL surgery over the first 5 days of the postoperative period
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): NCT03417479
|Contact: Margaret A Gettis, DNPemail@example.com|
|Contact: David J Nusz, MDfirstname.lastname@example.org|
|United States, Georgia|
|Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30043|
|Contact: David J Nusz, MD 404-785-2008 email@example.com|
|Contact: Margaret A Gettis, DNP 404-785-8622 firstname.lastname@example.org|
|Principal Investigator:||Margaret A Gettis, DNP||Children's Healthcare of Atlanta|