Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

— VITCRCR  

Official title:

Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992028
• Other study ID #: HCH 112294-01-201610-01
• Status: Recruiting
• Phase: Phase 4
• First received: December 7, 2016
• Last updated: December 10, 2016
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Himchan Hospital
• Contact: Ji Wan Park, M.D.
• Phone: +82-1090082712
• Email: wonkeepark[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of rotator cuff tear.

As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear annually more than 300,000 have been performed according to US statistics.

Rotator cuff repair is a successful procedure, both objectively and subjectively, with regard to pain relief and functional outcome.

2. postoperative pain management after rotator cuff repair Shoulder surgeries are associated with a level of postoperative pain requiring opioid use for several days. The opioid requirements after shoulder surgery have been reported to be similar to those required after gastrectomy or thoracotomy, which might cause several opioid-related side effects, such as nausea and vomiting, pruritus, urinary distention, and constipation. Although the introduction of arthroscopy has reduced postoperative pain, a considerable proportion of patients suffer from moderate to severe acute postoperative pain, as its benefit is typically apparent after a few days. Consequently, proactive pain control is also required during the first 24-48 h after arthroscopic shoulder surgeries, just like in open surgeries. Adequate pain management during the immediate postoperative period is not only important for patient satisfaction and well-being, but also for facilitating postoperative rehabilitation and preventing persistent postsurgical pain.

Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to have anti oxidant action, and fewer side effects.

However, there is no report about the analgesic effect of vitamin C after arthroscopic rotator cuff repair.

The purpose of this trial was to compare the effects of a intravenous vitamin C injection on postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator cuff repair.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Rotator cuff tear patients undergoing arthroscopic rotator cuff tear

Exclusion Criteria:

• age <45 or >80

• allergies to medications used in the study

• history of renal diseases, a coagulation abnormality, a hepatic disease, or drug abuse

• definite radiographic evidence of osteoarthritis of the glenohumeral joint

• inflammatory arthritis including rheumatoid arthritis

• a history of acute trauma

• systemic conditions associated with chronic pain

• a history of infection

• an inability to understand the questionnaires

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Tear

Intervention

Drug:
• Intravenous Nutrition (Vitamins) injection

• Intravenous Saline injection

Locations

Country	Name	City	State
Korea, Republic of	Himchan Hopital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Himchan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Ayatollahi V, Dehghanpoor-Farashah S, Behdad S, Vaziribozorg S, Rabbani Anari M. Effect of intravenous vitamin C on post-operative pain in uvulopalatopharyngoplasty with tonsillectomy. Clin Otolaryngol. 2016 May 24. doi: 10.1111/coa.12684. [Epub ahead of print] — View Citation

Coghlan JA, Forbes A, Bell SN, Buchbinder R. Efficacy and safety of a subacromial continuous ropivacaine infusion for post-operative pain management following arthroscopic rotator cuff surgery: a protocol for a randomised double-blind placebo-controlled trial. BMC Musculoskelet Disord. 2008 Apr 22;9:56. doi: 10.1186/1471-2474-9-56. — View Citation

Hasanzadeh Kiabi F, Soleimani A, Habibi MR, Emami Zeydi A. Can vitamin C be used as an adjuvant for managing postoperative pain? A short literature review. Korean J Pain. 2013 Apr;26(2):209-10. doi: 10.3344/kjp.2013.26.2.209. — View Citation

Jeon Y, Park JS, Moon S, Yeo J. Effect of Intravenous High Dose Vitamin C on Postoperative Pain and Morphine Use after Laparoscopic Colectomy: A Randomized Controlled Trial. Pain Res Manag. 2016;2016:9147279. — View Citation

Jo CH, Shin JS, Huh J. Multimodal analgesia for arthroscopic rotator cuff repair: a randomized, placebo-controlled, double-blind trial. Eur J Orthop Surg Traumatol. 2014 Apr;24(3):315-22. doi: 10.1007/s00590-013-1208-z. — View Citation

Sadeghpour A, Alizadehasl A, Kyavar M, Sadeghi T, Moludi J, Gholizadeh F, Totonchi Z, Ghadrdoost B. Impact of vitamin C supplementation on post-cardiac surgery ICU and hospital length of stay. Anesth Pain Med. 2015 Feb 19;5(1):e25337. doi: 10.5812/aapm.25337. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)	Recorded at 24 hours after surgery	No
Secondary	Postoperative narcotic consumption		up to postoperative 24 hours	No