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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
• Intervention / Treatment: Other: Gabapentin

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30043
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Gabapentin; Other Names: Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Margaret A Gettis, DNP, Children's Healthcare of Atlanta

Publications and helpful links

General Publications

• Gettis M, Brown AM, Fujimoto A, Wetzel M, Thomsen J. Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: A Pilot Study. J Perianesth Nurs. 2022 Oct;37(5):626-631. doi: 10.1016/j.jopan.2021.11.011. Epub 2022 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2015
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): October 23, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: CHOA IRB 15-094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No