Gabapentin and Chronic Post Surgical Pain

NCT03867240 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB00106205
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Scoliosis Idiopathic

Keywords

Gabapentin; Pain medication; Chronic postsurgical pain; Pediatric; Idiopathic scoliosis surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo

  Postoperative period up to 1 month

• 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

• Time to discharge in each group in patients receiving gabapentin versus standard of care

  Postoperative period up to 1 month

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Gabapentin DRUG

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.

Also known as: Neurontin

Gabapentin

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Cheryl Hartzell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 7, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)