Gabapentin and Chronic Post Surgical Pain

Pain, Postoperative Clinical Trial

— CPSP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03867240
• Other study ID #: IRB00106205
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2019
• Est. completion date: September 2022

Study information

• Verified date: February 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Scoliosis
• Scoliosis Idiopathic

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Time to ambulation in patients receiving gabapentin versus placebo	Time to ambulation will be recorded.	Postoperative period up to 1 month
Secondary	First oral intake in patients receiving gabapentin versus placebo	Time to first oral intake will be recorded.	Postoperative period up to 1 month
Secondary	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