Gabapentin Premedication for ACL Reconstruction: RCT

Anterior Cruciate Ligament (ACL) Reconstruction Clinical Trial

Official title:

Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417479
• Other study ID #: CHOA IRB 15-094
• Status: Completed
• Start date: October 9, 2015
• Est. completion date: October 23, 2018

Study information

• Verified date: July 2019
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament (ACL) Reconstruction

Intervention

Other:
• Gabapentin

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Dose determination	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	5 days post surgery