The Effectiveness of Vitamin C in Postoperative Pain Management of Single-level Posterior Lumbar Interbody Fusion (PLIF)

November 17, 2015 updated by: Jin S. Yeom, Seoul National University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyounggido
      • Seongnam-si, Gyounggido, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C
in postoperative time, vitamin C administered orally with other pain analgesics.
Drug: Vitamin C
for 1 month postoperative period, vitamin C was administered orally to the patients.
Placebo Comparator: Placebo drug
in postoperative time, vitamin C do not administered.
Drug: Placebo drug
for 1 month postoperative period, placebo medication administered orally to the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Postoperative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes on the ODI and SF-12
Time Frame: postoperative 3 and12 months
Postoperative functional outcomes were assessed with Oswestry disability index (ODI) and SF-12 score at postoperative 3 and 12 months.
postoperative 3 and12 months
Union rate
Time Frame: Postoperative 12 months
fusion outcome was evaluated at postoperative 12 months using dynamic radiographs and CT scans.
Postoperative 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin S. Yeom, M.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 27, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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