Fusion of Spine (Disease)NCT02127060
The Effectiveness of Vitamin C in Postoperative Pain Management of Single-level Posterior Lumbar Interbody Fusion (PLIF)
A study testing Vitamin C in people with Fusion of Spine (Disease), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative pain management remains a major challenge for surgeons. Despite huge technological advances in pain management, many researchers have documented that unrelieved pain remains common after surgeries, which is estimated that up to 75% of patients do not achieve adequate pain relief postoperatively. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fusion of Spine (Disease)
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to May 2014
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a lumbar herniated intervertebral disc, lumbar spondylotic radiculopathy and/or myelopathy, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
- patients who underwent one-level PLIF
- patients who volunteered for this study with written consent
- patient who were followed-up for one year or more
Who cannot join
- fractures, infection, or tumors in the lumbar spine
- patients with hemorrhagic disorders such as hemophilia and thrombocythemia
- patient with a follow-up period of less than one year
- patients who are not suitable for this study judged by the principal investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido
About this study
Postoperative pain management remains a major challenge for surgeons. Despite huge technological advances in pain management, many researchers have documented that unrelieved pain remains common after surgeries, which is estimated that up to 75% of patients do not achieve adequate pain relief postoperatively. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen the side effects while still providing adequate analgesia, because side effects of commonly used pain medications are known to be the reasons that could lead to inadequate postoperative pain treatment. This goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive and pain reducing effects is vitamin C.
Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially highly concentrated in the brain, which has antioxidant and neuroprotective properties. Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery and the requirement for vitamin C increases in surgical patients, possibly due to greater demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain, a result from a recent study with the aim to evaluate the potential role of vitamin C in reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral vitamin C significantly decreased morphine consumption after surgery.
Although vitamin C has potential for relieving postoperative pain, there has not been studied regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to evaluate the effectiveness of vitamin C for surgery of lumbar spine.
- Conditions
- Fusion of Spine (Disease)
- Being tested
- Vitamin C, Placebo drug
- Keywords
- vitamin C, effectiveness, pain management, posterior lumbar interbody fusion
- Medical subject headings
- Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
for 1 month postoperative period, vitamin C was administered orally to the patients.
Placebo drugDrug
for 1 month postoperative period, placebo medication administered orally to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | in postoperative time, vitamin C administered orally with other pain analgesics. Receives: Drug: Vitamin C |
| Placebo drug | Placebo comparator | in postoperative time, vitamin C do not administered. Receives: Drug: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the VAS
The pain intensity on lower back and radiating pain to lower extremities were recorded, separately using visual analogue scale (VAS)
Measured: Postoperative 1 month
Secondary outcomes (2)
Functional outcomes on the ODI and SF-12
Postoperative functional outcomes were assessed with Oswestry disability index (ODI) and SF-12 score at postoperative 3 and 12 months.
Measured: postoperative 3 and12 months
Union rate
fusion outcome was evaluated at postoperative 12 months using dynamic radiographs and CT scans.
Measured: Postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of Spine (Disease)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Jin S. Yeom, M.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127060
- Sponsor's protocol ID
- VITC-001
- Status last verified
- Nov 2015
- First submitted
- 27 Apr 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Vitamin C in Postoperative Pain Management of Single-level Posterior Lumbar Interbody Fusion (PLIF)
- ClinicalTrials.gov ID
- NCT02127060
- Acronym / sponsor ID
- VITC-001
- Conditions
- Fusion of Spine (Disease)
- Keywords
- vitamin C, effectiveness, pain management, posterior lumbar interbody fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
Postoperative pain management remains a major challenge for surgeons. Despite huge technological advances in pain management, many researchers have documented that unrelieved pain remains common after surgeries, which is estimated that up to 75% of patients do not achieve adequate pain relief postoperatively. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen the side effects while still providing adequate analgesia, because side effects of commonly used pain medications are known to be the reasons that could lead to inadequate postoperative pain treatment. This goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive and pain reducing effects is vitamin C.
Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially highly concentrated in the brain, which has antioxidant and neuroprotective properties. Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery and the requirement for vitamin C increases in surgical patients, possibly due to greater demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain, a result from a recent study with the aim to evaluate the potential role of vitamin C in reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral vitamin C significantly decreased morphine consumption after surgery.
Although vitamin C has potential for relieving postoperative pain, there has not been studied regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to evaluate the effectiveness of vitamin C for surgery of lumbar spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin Cin postoperative time, vitamin C administered orally with other pain analgesics. |
| Placebo drug | Placebo comparator | Drug: Placebo drugin postoperative time, vitamin C do not administered. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a lumbar herniated intervertebral disc, lumbar spondylotic radiculopathy and/or myelopathy, which were diagnosed using lumbar spine radiographs and magnetic resonance images (MRI) that corresponded to clinical manifestations and physical examinations
- patients who underwent one-level PLIF
- patients who volunteered for this study with written consent
- patient who were followed-up for one year or more
Key exclusion criteria (4 listed)
- fractures, infection, or tumors in the lumbar spine
- patients with hemorrhagic disorders such as hemophilia and thrombocythemia
- patient with a follow-up period of less than one year
- patients who are not suitable for this study judged by the principal investigator
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 |
|---|---|---|
| Vitamin Cfor 1 month postoperative period, vitamin C was administered orally to the patients. | Drug | Vitamin C |
| Placebo drugfor 1 month postoperative period, placebo medication administered orally to the patients. | Drug | Placebo drug |
Primary outcome
Pain scores on the VAS
Time frame: Postoperative 1 month
The pain intensity on lower back and radiating pain to lower extremities were recorded, separately using visual analogue scale (VAS)
2 secondary outcomes
Functional outcomes on the ODI and SF-12
Time frame: postoperative 3 and12 months
Union rate
Time frame: Postoperative 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Related trials for Fusion of Spine (Disease)
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
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.
Jin S. Yeom, M.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Fusion of Spine (Disease), run by Seoul National University Hospital at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 20 Nov 2015. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain scores on the VAS (time frame: Postoperative 1 month). 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 20 Nov 2015.