Clinical trial NCT02992028: Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
Official title: Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff repair
Vitamin C
postoperative pain
Lead sponsor: Himchan Hospital
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale
timeFrame: Recorded at 24 hours after surgery
Secondary outcomes:
measure: Postoperative narcotic consumption
timeFrame: up to postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Himchan Hopital
Study officials:
affiliation: Himchan Hospital
name: Ji Wan Park, M.D.
role: STUDY_CHAIR
References:
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. eCollection 2015 Feb.
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. Epub 2013 Mar 14.
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. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.
citation: 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.
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. Epub 2013 Apr 3. No abstract available.
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.