Ascorbic AcidNCT05514197
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
A study testing Ascorbic acid 100mg/kg, Maximus 10g in people with Ascorbic Acid and Postoperative Pain, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Ascorbic Acid, Postoperative Pain
- What is being tested?
- Ascorbic acid 100mg/kg, Maximus 10g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2022to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic opioid use (>3 months) or drug abuser
- Difficulty in communication (Impaired mental status)
- Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ascorbic Acid, Postoperative Pain
- Being tested
- Ascorbic acid 100mg/kg, Maximus 10g, Control Rx
- Keywords
- Ascorbic Acid, Total knee arthroplasty, Regional analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acid 100mg/kg, Maximus 10gDrug
Intravenous loading of 100mg/kg ascorbic acid with normal saline, totally 100ml Completed before induction
Control RxDrug
Intravenous loading 100ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C arm | Experimental | Intravenous loading of 100mg/kg ascorbic acid before induction, Maximus 10g Receives: Drug: Ascorbic acid 100mg/kg, Maximus 10g |
| Control arm | Placebo comparator | Intravenous loading of the same volume Normal saline as experimental arm Receives: Drug: Control Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale for pain
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: 15 minutes postoperatively
Numeric rating scale for pain
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: 1 hour postoperatively
Numeric rating scale for pain
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: 6 hours postoperatively
Numeric rating scale for pain
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: 24 hours postoperatively
Numeric rating scale for pain
11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Measured: 48 hours postoperatively
Numeric rating scale for soreness (Sngception)
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
Measured: 15 minutes after surgery
Numeric rating scale for soreness (Sngception)
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
Measured: 1 hours postoperatively
Numeric rating scale for soreness (Sngception)
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
Measured: 6 hours postoeratively
Numeric rating scale for soreness (Sngception)
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
Measured: 24 hours postoperatively
Numeric rating scale for soreness (Sngception)
11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness
Measured: 48 hours postoperatively
Secondary outcomes (3)
Morphine consumption
Amount of IV morphine consumption postoperatively
Measured: 48 hours postoperatively
Time to first rescue morphine requirement at post-anesthetic care unit
Duration from arriving post-anesthetic care unit to requiring first morphine injection
Measured: up to 2 hours
Severity of postoperative nausea/ vomiting and dizziness
From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start2 Nov 2022
- Primary completion13 Dec 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascorbic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen-Yin Chen, Study director, Department of Anesthesiology, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514197
- Sponsor's protocol ID
- CMMC11104/016
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT05514197
- Acronym / sponsor ID
- CMMC11104/016
- Conditions
- Ascorbic Acid, Postoperative Pain
- Keywords
- Ascorbic Acid, Total knee arthroplasty, Regional analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C arm | Experimental | Drug: Ascorbic acid 100mg/kg, Maximus 10gIntravenous loading of 100mg/kg ascorbic acid before induction, Maximus 10g |
| Control arm | Placebo comparator | Drug: Control RxIntravenous loading of the same volume Normal saline as experimental arm |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acid 100mg/kg, Maximus 10gIntravenous loading of 100mg/kg ascorbic acid with normal saline, totally 100ml Completed before induction | Drug | Vitamin C arm |
| Control RxIntravenous loading 100ml normal saline | Drug | Control arm |
Primary outcome
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
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
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
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
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
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
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
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
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
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
3 secondary outcomes
Morphine consumption
Time frame: 48 hours postoperatively
Time to first rescue morphine requirement at post-anesthetic care unit
Time frame: up to 2 hours
Severity of postoperative nausea/ vomiting and dizziness
Time frame: 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Yin Chen study director
Department of Anesthesiology, Chimei Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid 100mg/kg, Maximus 10g in people with Ascorbic Acid and Postoperative Pain, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale for pain (time frame: 15 minutes postoperatively). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.