Gabapentin Premedication for ACL Reconstruction: RCT

Completed

• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
• Interventions: Other: Gabapentin

• Registration Number: NCT03417479
• Lead Sponsor: Children's Healthcare of Atlanta

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-10-09
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Primary Completion: 2018-10-23
• Study Completion: 2018-10-23
• Status Verified: 2019-07
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1:1 Randomization	Gabapentin	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.

Primary Outcome Measures

Name	Time	Method
Effective Dose determination	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

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States