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

NCT02127060 | Completed

• 1 other identifier: VITC-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

vitamin C; effectiveness; pain management; posterior lumbar interbody fusion

Outcome Measures

Primary Outcomes (1)

• 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)

  Postoperative 1 month

Secondary Outcomes (2)

• Functional outcomes on the ODI and SF-12

  postoperative 3 and12 months

• Union rate

  Postoperative 12 months

Study Arms (2)

Vitamin C

EXPERIMENTAL

in postoperative time, vitamin C administered orally with other pain analgesics.

Drug: Vitamin C

Placebo drug

PLACEBO COMPARATOR

in postoperative time, vitamin C do not administered.

Drug: Placebo drug

Interventions

Vitamin C DRUG

for 1 month postoperative period, vitamin C was administered orally to the patients.

Vitamin C

Placebo drug DRUG

for 1 month postoperative period, placebo medication administered orally to the patients.

Placebo drug

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Location

MeSH Terms

Conditions

Disease; Agnosia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Jin S. Yeom, M.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seoul National University

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: April 30, 2014
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

KR (1)