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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Physical status according to American Society of Anesthesiologists (ASA) I-III
  2. Patients scheduled for total knee arthroplasty
  3. Patients aged ranging from 50 to 80 years old

Exclusion Criteria:

  1. Previous operation on the same knee
  2. Allergy or intolerance to one of the study medications
  3. Coagulopathy
  4. Having lower limbs neuropathy
  5. End-organ failure (CKD stage IV or V, NYHA III or IV)
  6. BMI > 35
  7. Chronic opioid use (>3 months) or drug abuser
  8. Difficulty in communication (Impaired mental status)
  9. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control arm
Intravenous loading of the same volume Normal saline as experimental arm
Drug: Control Rx
Intravenous loading 100ml normal saline
Experimental: Vitamin C arm
Intravenous loading of 100mg/kg ascorbic acid before induction, Maximus 10g
Drug: Ascorbic acid 100mg/kg, 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chimei Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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