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

Primary Purpose

Rotator Cuff Tear

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravenous Nutrition (Vitamins) injection
Intravenous Saline injection
Sponsored by
Himchan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tear focused on measuring Rotator cuff repair, Vitamin C, postoperative pain

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Himchan HopitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous vitamin C injection

Intravenous saline injection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative narcotic consumption

Full Information

First Posted
December 7, 2016
Last Updated
December 10, 2016
Sponsor
Himchan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02992028
Brief Title
Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
Acronym
VITCRCR
Official Title
Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Himchan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator cuff repair, Vitamin C, postoperative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous vitamin C injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous saline injection
Arm Type
Placebo Comparator
Arm Description
During the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer.
Intervention Type
Drug
Intervention Name(s)
Intravenous Nutrition (Vitamins) injection
Other Intervention Name(s)
Preoperative Vitamin C injection
Intervention Type
Drug
Intervention Name(s)
Intravenous Saline injection
Other Intervention Name(s)
Preoperative Saline injection
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)
Time Frame
Recorded at 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative narcotic consumption
Time Frame
up to postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Wan Park, M.D.
Phone
+82-1090082712
Email
wonkeepark@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Wan Park, M.D.
Organizational Affiliation
Himchan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Himchan Hopital
City
Seoul
ZIP/Postal Code
01459
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Wan Park, M.D.
Phone
+82-1090082712
Email
wonkeepark@naver.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25789244
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.
Results Reference
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PubMed Identifier
23494779
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.
Results Reference
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PubMed Identifier
27872555
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.
Results Reference
background
PubMed Identifier
27219124
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.
Results Reference
background
PubMed Identifier
23614091
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.
Results Reference
background
PubMed Identifier
18430210
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.
Results Reference
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Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair

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