NCT05514197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2024

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

August 16, 2022

Last Update Submit

November 17, 2025

Conditions

Ascorbic AcidPostoperative Pain

Keywords

Ascorbic AcidTotal knee arthroplastyRegional analgesia

Outcome Measures

Primary Outcomes (10)

  • Numeric rating scale for pain

    11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain

    15 minutes postoperatively

  • Numeric rating scale for pain

    11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain

    1 hour postoperatively

  • Numeric rating scale for pain

    11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain

    6 hours postoperatively

  • Numeric rating scale for pain

    11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain

    24 hours postoperatively

  • Numeric rating scale for pain

    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)

    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)

    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)

    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)

    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)

    11-point numeric scale ranges from '0' representing no soreness to '10' representing the extreme soreness

    48 hours postoperatively

Secondary Outcomes (3)

  • Morphine consumption

    48 hours postoperatively

  • Time to first rescue morphine requirement at post-anesthetic care unit

    up to 2 hours

  • Severity of postoperative nausea/ vomiting and dizziness

    48 hours postoperatively

Other Outcomes (2)

  • Blood ascorbic acid concentration

    Preoperative baseline and postoperative day1

  • PostOP Knee joint range of motion

    72 hours postoperatively

Study Arms (2)

Vitamin C arm

EXPERIMENTAL

Intravenous loading of 100mg/kg ascorbic acid before induction, Maximus 10g

Drug: Ascorbic acid 100mg/kg, Maximus 10g

Control arm

PLACEBO COMPARATOR

Intravenous loading of the same volume Normal saline as experimental arm

Drug: Control Rx

Interventions

Ascorbic acid 100mg/kg, Maximus 10gDRUG

Intravenous loading of 100mg/kg ascorbic acid with normal saline, totally 100ml Completed before induction

Vitamin C arm
Control RxDRUG

Intravenous loading 100ml normal saline

Control arm

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Mei Medical Center

Tainan, Tainan City, 701, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ascorbic AcidTin Fluorides

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesFluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jen-Yin Chen

    Department of Anesthesiology, Chimei Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 24, 2022

Study Start

November 2, 2022

Primary Completion

December 13, 2023

Study Completion

January 11, 2024

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

TW(1)