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Gabapentin Premedication for ACL Reconstruction: RCT

NCT ID: NCT03417479

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-09

Study Completion Date

2018-10-23

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament (ACL) Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gabapentin

Intervention Type OTHER

Interventions

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Gabapentin

Intervention Type OTHER

Other Intervention Names

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Neurontin

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret A Gettis, DNP

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35256248 (View on PubMed)

Other Identifiers

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CHOA IRB 15-094

Identifier Type: -

Identifier Source: org_study_id