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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05514197
• Other study ID #: CMMC11104/016
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 7, 2023

Study information

• Verified date: April 2024
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascorbic Acid
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chi Mei Medical Center	Tainan	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood ascorbic acid concentration	Blood ascorbic acid analysis	Preoperative baseline and postoperative day1
Other	PostOP Knee joint range of motion	In degree from zero to 170	72 hours postoperatively
Primary	Visual analogue scale for pain	Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain	15 minutes postoperatively
Primary	Visual analogue scale for pain	Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain	first hour postoperatively
Primary	Visual analogue scale for pain	Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain	6th hour postoperatively
Primary	Visual analogue scale for pain	Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain	24th hour postoperatively
Primary	Visual analogue scale for pain	Marking on a continuous 10 centimeter line from 0 to 10, representing no pain to worst pain	48th hour postoperatively
Secondary	Visual analogue scale for sngcetion	Marking on a continuous 10 centimeter line from 0 to 10, representing no sore to worst sore	48 hours postoperatively
Secondary	Morphine consumption	Amount of IM morphine consumption in the first 24 hours postoperatively	24 hours postoperatively
Secondary	Time to first rescue morphine requirement at post-anesthetic care unit	Duration from arriving post-anesthetic care unit to requiring first morphine injection	up to 2 hours
Secondary	Severity of postoperative nausea/ vomiting and dizziness	From 0 to 5, 0: non, 1: mild, 2: moderate, 3: severe, 4: unbearable	48 hours postoperatively