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Gabapentin Premedication for ACL Reconstruction: RCT

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ClinicalTrials.gov Identifier: NCT03417479
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

September 26, 2017
January 31, 2018
July 23, 2018
October 9, 2015
June 6, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03417479 on ClinicalTrials.gov Archive Site
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Gabapentin Premedication for ACL Reconstruction: RCT
Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial
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 participants interviews with a phone nurse for five days postoperatively to determine severity of pain as well as use of opioids.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Inclusion criteria include patients ages 12-18 years with an ASA class 1 or 2 scheduled for elective ACL reconstruction in the outpatient setting by Dr. Michael Busch. Exclusion criteria include a BMI >40, recurrent ACL reconstruction, allograft ACL reconstruction, history of renal insufficiency, chronic pain or allergy to gabapentin.
Anterior Cruciate Ligament (ACL) Reconstruction
Other: Gabapentin
Other Name: Neurontin
1:1 Randomization
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.
Intervention: Other: Gabapentin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
September 1, 2018
June 6, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA classification 1 or 2
  • Scheduled for elective ACL surgery in pediatric outpatient setting

Exclusion Criteria:

  • BMI greater than 40
  • ASA classification greater than 2
  • Recurrent ACL reconstruction
  • Allograft ACL reconstruction
  • History of renal insufficiency
  • History of chronic pain
  • Allergy to Gabapentin
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
Yes
Contact: Margaret A Gettis, DNP 404-785-8622 margaret.gettis@choa.org
Contact: David J Nusz, MD 404-785-2008 david.nusz@choa.org
United States
 
 
NCT03417479
CHOA IRB 15-094
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
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Principal Investigator: Margaret A Gettis, DNP Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
January 2018