Clinical trial NCT03417479: Gabapentin Premedication for ACL Reconstruction: RCT
Official title: Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 57
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effective Dose determination
timeFrame: 5 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Margaret A Gettis, DNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.