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

Fusion of Spine (Disease) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127060
• Other study ID #: VITC-001
• Status: Completed
• Phase: N/A
• First received: April 27, 2014
• Last updated: November 17, 2015
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fusion of Spine (Disease)

Intervention

Drug:
• Vitamin C
for 1 month postoperative period, vitamin C was administered orally to the patients.
• Placebo drug
for 1 month postoperative period, placebo medication administered orally to the patients.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	postoperative 3 and12 months	No
Secondary	Union rate	fusion outcome was evaluated at postoperative 12 months using dynamic radiographs and CT scans.	Postoperative 12 months	No