Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
NCT ID: NCT02992028
Last Updated: 2016-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
54 participants
INTERVENTIONAL
2016-12-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intravenous vitamin C injection
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.
Intravenous Nutrition (Vitamins) injection
Intravenous saline injection
During the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer.
Intravenous Saline injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intravenous Saline injection
Intravenous Nutrition (Vitamins) injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
45 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Himchan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ji Wan Park
Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ji Wan Park, M.D.
Role: STUDY_CHAIR
Himchan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Himchan Hopital
Seoul, Seoul, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ji Wan Park, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCH 112294-01-201610-01
Identifier Type: -
Identifier Source: org_study_id