Back to resultsThe Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
Primary Purpose
Ascorbic Acid, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ascorbic acid 5000mg
Control Rx
Sponsored by
About this trial
This is an interventional treatment trial for Ascorbic Acid focused on measuring Ascorbic Acid, Total knee arthroplasty, Regional analgesia
Eligibility Criteria
Inclusion Criteria:
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
- Age 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 V or VI, NYHA III or IV)
- BMI > 35
- Chronic opioid use or drug abuser
- Difficulty in communication (Impaired mental status)
- Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient
Sites / Locations
- Chi Mei Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin C arm
Control arm
Arm Description
Intravenous loading of 5g ascorbic acid before incision of wound
Intravenous loading of the same volume Normal saline as experimental arm
Outcomes
Primary Outcome Measures
Visual analogue scale for pain
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Visual analogue scale for pain
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Visual analogue scale for pain
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Visual analogue scale for pain
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Visual analogue scale for pain
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Secondary Outcome Measures
Visual analogue scale for sngcetion
Marking on a continuous 10 centimeter line from 0 to 10, representing no sore to worst sore
Morphine consumption
Amount of IM morphine consumption in the first 24 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
Severity of postoperative nausea/ vomiting and dizziness
From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514197
Brief Title
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
Official Title
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimei Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascorbic Acid, Postoperative Pain
Keywords
Ascorbic Acid, Total knee arthroplasty, Regional analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C arm
Arm Type
Experimental
Arm Description
Intravenous loading of 5g ascorbic acid before incision of wound
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Intravenous loading of the same volume Normal saline as experimental arm
Intervention Type
Drug
Intervention Name(s)
Ascorbic acid 5000mg
Intervention Description
Intravenous loading of 5000mg ascorbic acid with normal saline, totally 100ml Completed before surgical incision
Intervention Type
Drug
Intervention Name(s)
Control Rx
Intervention Description
Intravenous loading 100ml normal saline
Primary Outcome Measure Information:
Title
Visual analogue scale for pain
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Time Frame
15 minutes postoperatively
Title
Visual analogue scale for pain
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Time Frame
first hour postoperatively
Title
Visual analogue scale for pain
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Time Frame
6th hour postoperatively
Title
Visual analogue scale for pain
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Time Frame
24th hour postoperatively
Title
Visual analogue scale for pain
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain
Time Frame
48th hour postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue scale for sngcetion
Description
Marking on a continuous 10 centimeter line from 0 to 10, representing no sore to worst sore
Time Frame
48 hours postoperatively
Title
Morphine consumption
Description
Amount of IM morphine consumption in the first 24 hours postoperatively
Time Frame
24 hours postoperatively
Title
Time to first rescue morphine requirement at post-anesthetic care unit
Description
Duration from arriving post-anesthetic care unit to requiring first morphine injection
Time Frame
up to 2 hours
Title
Severity of postoperative nausea/ vomiting and dizziness
Description
From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable
Time Frame
48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Blood ascorbic acid concentration
Description
Blood ascorbic acid analysis
Time Frame
Preoperative baseline and postoperative day1
Title
PostOP Knee joint range of motion
Description
In degree from zero to 170
Time Frame
72 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA) I-III
Patients scheduled for total knee arthroplasty
Age 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 V or VI, NYHA III or IV)
BMI > 35
Chronic opioid use or drug abuser
Difficulty in communication (Impaired mental status)
Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Yin Chen
Organizational Affiliation
Department of Anesthesiology, Chimei Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Chi Mei Medical Center
City
Tainan
State/Province
Tainan City
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
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