CPSP: Gabapentin and Chronic Post Surgical Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Gabapentin
Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients <50 kg and 200 mg for patients > 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
Other Names:
|
| Placebo Comparator: 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. |
Other: Placebo
Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, 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. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.
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Outcome Measures
Primary Outcome Measures
- Change in NRS for pain intensity score comparing gabapentin and placebo groups [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 [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 Outcome Measures
- Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo [Postoperative period up to 1 month]
Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents.
- Time to ambulation in patients receiving gabapentin versus placebo [Postoperative period up to 1 month]
Time to ambulation will be recorded.
- First oral intake in patients receiving gabapentin versus placebo [Postoperative period up to 1 month]
Time to first oral intake will be recorded.
- Time to discharge in each group in patients receiving gabapentin versus standard of care [Postoperative period up to 1 month]
Time to discharge will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be aged 10-18 years at the time of surgery
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Have a diagnosis of idiopathic scoliosis and/or kyphosis
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Be undergoing elective posterior spinal fusion
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Have only mild systemic disease
Exclusion Criteria:
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A diagnosis of neuromuscular scoliosis and/or kyphosis
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A diagnosis of chronic pain
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Used opioids in the past 6 months
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Developmental delay
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Liver or kidney disease
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Obstructive sleep apnea
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Body mass index >40
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Be pregnant or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
Investigators
- Principal Investigator: Cheryl Hartzell, MD, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00106205