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Gabapentin and Chronic Post Surgical Pain (CPSP)

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ClinicalTrials.gov Identifier: NCT03867240
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : March 7, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Cheryl Hartzell, Emory University

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo [ Time Frame: 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 [ Time Frame: Postoperative period up to 1 month ]
    Time to ambulation will be recorded.
  • First oral intake in patients receiving gabapentin versus placebo [ Time Frame: 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 [ Time Frame: Postoperative period up to 1 month ]
    Time to discharge will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gabapentin and Chronic Post Surgical Pain
Official Title  ICMJE The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Scoliosis Idiopathic
Intervention  ICMJE
  • 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 Name: Neurontin
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Gabapentin
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 6, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867240
Other Study ID Numbers  ICMJE IRB00106205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: Data will become available immediately following publication and ending 5 years following article publication.
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.
Responsible Party Cheryl Hartzell, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheryl Hartzell, MD Emory University
PRS Account Emory University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP