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The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty

Sponsor
Chimei Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05514197
Collaborator
(none)
100
Enrollment
2
Arms
9.2
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ascorbic acid 5000mg
  • Drug: Control Rx
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin C arm

Intravenous loading of 5g ascorbic acid before incision of wound

Drug: Ascorbic acid 5000mg
Intravenous loading of 5000mg ascorbic acid with normal saline, totally 100ml Completed before surgical incision
Placebo Comparator: Control arm

Intravenous loading of the same volume Normal saline as experimental arm

Drug: Control Rx
Intravenous loading 100ml normal saline

Outcome Measures

Primary Outcome Measures

  1. Visual analogue scale for pain [15 minutes postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain

  2. Visual analogue scale for pain [first hour postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain

  3. Visual analogue scale for pain [6th hour postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain

  4. Visual analogue scale for pain [24th hour postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain

  5. Visual analogue scale for pain [48th hour postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain

Secondary Outcome Measures

  1. Visual analogue scale for sngcetion [48 hours postoperatively]

    Marking on a continuous 10 centimeter line from 0 to 10, representing no sore to worst sore

  2. Morphine consumption [24 hours postoperatively]

    Amount of IM morphine consumption in the first 24 hours postoperatively

  3. Time to first rescue morphine requirement at post-anesthetic care unit [up to 2 hours]

    Duration from arriving post-anesthetic care unit to requiring first morphine injection

  4. Severity of postoperative nausea/ vomiting and dizziness [48 hours postoperatively]

    From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable

Other Outcome Measures

  1. Blood ascorbic acid concentration [Preoperative baseline and postoperative day1]

    Blood ascorbic acid analysis

  2. PostOP Knee joint range of motion [72 hours postoperatively]

    In degree from zero to 170

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Physical status according to American Society of Anesthesiologists (ASA) I-III

  2. Patients scheduled for total knee arthroplasty

  3. Age 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 V or VI, NYHA III or IV)

  6. BMI > 35

  7. Chronic opioid use or drug abuser

  8. Difficulty in communication (Impaired mental status)

  9. Hyperuricemia or Glucose-6-phosphate dehydrogenase deficiency patient

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chimei Medical Center

Investigators

  • Study Director: Jen-Yin Chen, Department of Anesthesiology, Chimei Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT05514197
Other Study ID Numbers:
  • CMMC11104/016
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chimei Medical Center
Ascorbic Acid
Total knee arthroplasty
Regional analgesia
Additional relevant MeSH terms:
Pain, Postoperative
Ascorbic Acid

Study Results

No Results Posted as of Aug 24, 2022