The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
Overview
- Phase
- Phase 3
- Intervention
- Gabapentin
- Conditions
- Pain, Postoperative
- Sponsor
- Emory University
- Locations
- 1
- Primary Endpoint
- Change in NRS for pain intensity score comparing gabapentin and placebo groups
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.
Detailed Description
Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.
Investigators
Cheryl Hartzell
Assistant Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •Be aged 10-18 years at the time of surgery
- •Have a diagnosis of idiopathic scoliosis and/or kyphosis
- •Be undergoing elective posterior spinal fusion
- •Have only mild systemic disease
Exclusion Criteria
- •A diagnosis of neuromuscular scoliosis and/or kyphosis
- •A diagnosis of chronic pain
- •Used opioids in the past 6 months
- •Developmental delay
- •Liver or kidney disease
- •Obstructive sleep apnea
- •Body mass index \>40
- •Be pregnant or breastfeeding
Arms & Interventions
Gabapentin
Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.
Intervention: Gabapentin
Placebo
Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in NRS for pain intensity score comparing gabapentin and placebo groups
Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS \> 4/10 at the time of the survey will be considered positive for CPSP.
Change in FDI score comparing gabapentin and placebo groups
Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60).
Secondary Outcomes
- Time to ambulation in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- First oral intake in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo(Postoperative period up to 1 month)
- Time to discharge in each group in patients receiving gabapentin versus standard of care(Postoperative period up to 1 month)