- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514197
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
November 17, 2025 updated by: Chimei Medical Center
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty.
The aim of this prospective randomized-control study was to evaluate the impact of a single high-dose intravenous vitamin C added to ultrasound-guided blocks at induction on postoperative pain, sngception and early functional rehabilitation of the knee joint in patients under-going total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
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
-
-
Tainan City
-
Tainan, Tainan City, Taiwan, 701
- Chi Mei Medical Center
-
-
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
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
- Patients aged ranging from 50 to 80 years old
Exclusion Criteria:
- Previous operation on the same knee
- Allergy or intolerance to one of the study medications
- Coagulopathy
- Having lower limbs neuropathy
- End-organ failure (CKD stage IV or V, NYHA III or IV)
- BMI > 35
- Chronic opioid use (>3 months) or drug abuser
- Difficulty in communication (Impaired mental status)
- Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control arm
Intravenous loading of the same volume Normal saline as experimental arm
|
Intravenous loading 100ml normal saline
|
|
Experimental: Vitamin C arm
Intravenous loading of 100mg/kg ascorbic acid before induction, Maximus 10g
|
Intravenous loading of 100mg/kg ascorbic acid with normal saline, totally 100ml Completed before induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale for pain
Time Frame: 15 minutes postoperatively
|
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
|
15 minutes postoperatively
|
|
Numeric rating scale for pain
Time Frame: 1 hour postoperatively
|
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
|
1 hour postoperatively
|
|
Numeric rating scale for pain
Time Frame: 6 hours postoperatively
|
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
|
6 hours postoperatively
|
|
Numeric rating scale for pain
Time Frame: 24 hours postoperatively
|
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
|
24 hours postoperatively
|
|
Numeric rating scale for pain
Time Frame: 48 hours postoperatively
|
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
|
48 hours postoperatively
|
|
Numeric rating scale for soreness (Sngception)
Time Frame: 15 minutes after surgery
|
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
|
15 minutes after surgery
|
|
Numeric rating scale for soreness (Sngception)
Time Frame: 1 hours postoperatively
|
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
|
1 hours postoperatively
|
|
Numeric rating scale for soreness (Sngception)
Time Frame: 6 hours postoeratively
|
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
|
6 hours postoeratively
|
|
Numeric rating scale for soreness (Sngception)
Time Frame: 24 hours postoperatively
|
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
|
24 hours postoperatively
|
|
Numeric rating scale for soreness (Sngception)
Time Frame: 48 hours postoperatively
|
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
|
48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue morphine requirement at post-anesthetic care unit
Time Frame: up to 2 hours
|
Duration from arriving post-anesthetic care unit to requiring first morphine injection
|
up to 2 hours
|
|
Severity of postoperative nausea/ vomiting and dizziness
Time Frame: 48 hours postoperatively
|
From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable
|
48 hours postoperatively
|
|
Morphine consumption
Time Frame: 48 hours postoperatively
|
Amount of IV morphine consumption postoperatively
|
48 hours postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood ascorbic acid concentration
Time Frame: Preoperative baseline and postoperative day1
|
Blood ascorbic acid analysis
|
Preoperative baseline and postoperative day1
|
|
PostOP Knee joint range of motion
Time Frame: 72 hours postoperatively
|
In degree from zero to 170
|
72 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jen-Yin Chen, Department of Anesthesiology, Chimei Medical Center
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 (Actual)
November 2, 2022
Primary Completion (Actual)
December 13, 2023
Study Completion (Actual)
January 11, 2024
Study Registration Dates
First Submitted
August 16, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (Actual)
August 24, 2022
Study Record Updates
Last Update Posted (Estimated)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Cariostatic Agents
- Organic Chemicals
- Carbohydrates
- Sugar Acids
- Acids, Acyclic
- Carboxylic Acids
- Hydroxy Acids
- Inorganic Chemicals
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Fluorides
- Hydrofluoric Acid
- Fluorine Compounds
- Tin Compounds
- Ascorbic Acid
- Tin Fluorides
Other Study ID Numbers
- CMMC11104/016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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