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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02127060

Collaborator

(none)

112

Enrollment

Location

Arms

14.9

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fusion of Spine (Disease)	Drug: Vitamin C Drug: Placebo drug	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain scores on the VAS [Postoperative 1 month]
The pain intensity on lower back and radiating pain to lower extremities were recorded, separately using visual analogue scale (VAS)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyounggido	Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin S. Yeom, Seoul National University, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02127060

Other Study ID Numbers:

VITC-001

First Posted:

Apr 30, 2014

Last Update Posted:

Nov 20, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Jin S. Yeom, Seoul National University, Seoul National University Hospital

vitamin C

effectiveness

pain management

posterior lumbar interbody fusion

Additional relevant MeSH terms:

Ascorbic Acid

Study Results

No Results Posted as of Nov 20, 2015