Gabapentin and Chronic Post Surgical Pain (CPSP)

The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.

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 Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Scoliosis Idiopathic
• Intervention / Treatment: Drug: Gabapentin; Other: Placebo

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Neurontin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NRS for pain intensity score comparing gabapentin and placebo groups	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.	Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
Change in FDI score comparing gabapentin and placebo groups	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).	Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo	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.	Postoperative period up to 1 month
Time to ambulation in patients receiving gabapentin versus placebo	Time to ambulation will be recorded.	Postoperative period up to 1 month
First oral intake in patients receiving gabapentin versus placebo	Time to first oral intake will be recorded.	Postoperative period up to 1 month
Time to discharge in each group in patients receiving gabapentin versus standard of care	Time to discharge will be recorded.	Postoperative period up to 1 month

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Cheryl Hartzell, MD, Emory University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric; Gabapentin; Chronic postsurgical pain; Pain medication; Idiopathic scoliosis surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Pain, Postoperative; Scoliosis; 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: IRB00106205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
• IPD Sharing Time Frame: Data will become available immediately following publication and ending 5 years following article publication.
• IPD Sharing Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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