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

NCT02992028 | Unknown Phase 4

• 1 other identifier: HCH 112294-01-201610-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff repair; Vitamin C; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)

  Recorded at 24 hours after surgery

Secondary Outcomes (1)

• Postoperative narcotic consumption

  up to postoperative 24 hours

Study Arms (2)

Intravenous vitamin C injection

EXPERIMENTAL

During the first 30 min after beginning of the rotator cuff repair, treatment group received infusion of 3 g vitamin C (ascorbic acid) in 500 ml of Ringer.

Drug: Intravenous Nutrition (Vitamins) injection

Intravenous saline injection

PLACEBO COMPARATOR

During the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer.

Drug: Intravenous Saline injection

Interventions

Intravenous Nutrition (Vitamins) injection DRUG

Also known as: Preoperative Vitamin C injection

Intravenous vitamin C injection

Intravenous Saline injection DRUG

Also known as: Preoperative Saline injection

Intravenous saline injection

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rotator cuff tear patients undergoing arthroscopic rotator cuff tear

You may not qualify if:

• 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

Sponsors & Collaborators

• Himchan Hospital: lead

Study Sites (1)

Himchan Hopital

Seoul, Seoul, 01459, South Korea

RECRUITING

Related Publications (6)

• 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. eCollection 2015 Feb.

  PMID: 25789244 BACKGROUND

• 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. Epub 2013 Mar 14.

  PMID: 23494779 BACKGROUND

• 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. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.

  PMID: 27872555 BACKGROUND

• Ayatollahi V, Dehghanpour Farashah S, Behdad S, Vaziribozorg S, Rabbani Anari M. Effect of intravenous vitamin C on postoperative pain in uvulopalatopharyngoplasty with tonsillectomy. Clin Otolaryngol. 2017 Feb;42(1):139-143. doi: 10.1111/coa.12684. Epub 2016 Jun 7.

  PMID: 27219124 BACKGROUND

• 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. Epub 2013 Apr 3. No abstract available.

  PMID: 23614091 BACKGROUND

• 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.

  PMID: 18430210 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Interventions

Vitamins; Injections

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ji Wan Park, M.D.

  Himchan Hospital

  STUDY CHAIR

Central Study Contacts

Ji Wan Park, M.D.

CONTACT

+82-1090082712; wonkeepark@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

KR (1)