Rotator Cuff TearPhase 4VITCRCRNCT02992028
Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
A Phase 4 study testing Intravenous Nutrition (Vitamins) injection and Intravenous Saline injection in people with Rotator Cuff Tear, run by Himchan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Intravenous Nutrition (Vitamins) injection and Intravenous Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rotator cuff tear patients undergoing arthroscopic rotator cuff tear
Who cannot join
- 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
Show all 9Show fewer
- systemic conditions associated with chronic pain
- a history of infection
- an inability to understand the questionnaires
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Himchan Hopital
Seoul, Seoul, 01459
Ji Wan Park, M.D., +82-1090082712, wonkeepark@naver.com
About this study
Official title: Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
- 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.
Read more
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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Intravenous Nutrition (Vitamins) injection, Intravenous Saline injection
- Keywords
- Rotator cuff repair, Vitamin C, postoperative pain
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Nutrition (Vitamins) injectionDrug
Also called Preoperative Vitamin C injection
Intravenous Saline injectionDrug
Also called Preoperative Saline injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)
Measured: Recorded at 24 hours after surgery
Secondary outcomes (1)
Postoperative narcotic consumption
Measured: up to postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Himchan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Wan Park, Himchan Hospital
- Investigators
- Ji Wan Park, M.D., Study chair, Himchan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992028
- Sponsor's protocol ID
- HCH 112294-01-201610-01
- Acronym
- VITCRCR
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25789244Jo 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.
PubMed 23494779Jeon 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.
PubMed 27872555Ayatollahi 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.
PubMed 27219124Hasanzadeh 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.
PubMed 23614091Coghlan 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.
PubMed 18430210
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT02992028
- Acronym / sponsor ID
- VITCRCR / HCH 112294-01-201610-01
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff repair, Vitamin C, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Himchan HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous vitamin C injection | Experimental | Drug: Intravenous Nutrition (Vitamins) injectionDuring 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 saline injection | Placebo comparator | Drug: Intravenous Saline injectionDuring the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rotator cuff tear patients undergoing arthroscopic rotator cuff tear
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Nutrition (Vitamins) injectionAlso: Preoperative Vitamin C injection | Drug | Intravenous vitamin C injection |
| Intravenous Saline injectionAlso: Preoperative Saline injection | Drug | Intravenous saline injection |
Primary outcome
Visual analogue scale
Time frame: Recorded at 24 hours after surgery
from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)
1 secondary outcome
Postoperative narcotic consumption
Time frame: up to postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Background: PubMed 25789244Sadeghpour 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.
- Background: PubMed 23494779Jo 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.
- Background: PubMed 27872555Jeon 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.
- Background: PubMed 27219124Ayatollahi 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.
- Background: PubMed 23614091Hasanzadeh 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.
- Background: PubMed 18430210Coghlan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Wan Park, M.D. study chair
Himchan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Nutrition (Vitamins) injection and Intravenous Saline injection in people with Rotator Cuff Tear, run by Himchan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Wan Park, M.D. (+82-1090082712, wonkeepark@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: Recorded at 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992028, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.