Pain, PostoperativePhase 3CPSPNCT03867240
Gabapentin and Chronic Post Surgical Pain
A Phase 3 study testing Gabapentin in people with Pain, Postoperative and Scoliosis Idiopathic, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pain, Postoperative, Scoliosis Idiopathic
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Scoliosis Idiopathic
- Being tested
- Gabapentin, Placebo
- Keywords
- Gabapentin, Pain medication, Chronic postsurgical pain, Pediatric, Idiopathic scoliosis surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: Postoperative period up to 1 month
Time to ambulation in patients receiving gabapentin versus placebo
Time to ambulation will be recorded.
Measured: Postoperative period up to 1 month
First oral intake in patients receiving gabapentin versus placebo
Time to first oral intake will be recorded.
Measured: 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.
Measured: Postoperative period up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study startJun 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Hartzell, Emory University
- Investigators
- Cheryl Hartzell, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867240
- Sponsor's protocol ID
- IRB00106205
- Acronym
- CPSP
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
- ClinicalTrials.gov ID
- NCT03867240
- Acronym / sponsor ID
- CPSP / IRB00106205
- Conditions
- Pain, Postoperative, Scoliosis Idiopathic
- Keywords
- Gabapentin, Pain medication, Chronic postsurgical pain, Pediatric, Idiopathic scoliosis surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively. |
| Placebo | Placebo comparator | Other: PlaceboControl 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: NeurontinGabapentin (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. | Drug | Gabapentin |
| PlaceboPlacebo 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. | Other | Placebo |
Primary outcome
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).
4 secondary outcomes
Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo
Time frame: Postoperative period up to 1 month
Time to ambulation in patients receiving gabapentin versus placebo
Time frame: Postoperative period up to 1 month
First oral intake in patients receiving gabapentin versus placebo
Time frame: Postoperative period up to 1 month
Time to discharge in each group in patients receiving gabapentin versus standard of care
Time frame: Postoperative period up to 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Hartzell, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Pain, Postoperative and Scoliosis Idiopathic, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.