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

December 10, 2016 updated by: Ji Wan Park, Himchan Hospital

Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Intravenous Nutrition (Vitamins) injection
Other Names:
  • Preoperative Vitamin C injection
PLACEBO_COMPARATOR: 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.
Drug: Intravenous Saline injection
Other Names:
  • Preoperative Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Recorded at 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative narcotic consumption
Time Frame: up to postoperative 24 hours
up to postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Himchan Hospital

Investigators

  • Study Chair: Ji Wan Park, M.D., Himchan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 10, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCH 112294-01-201610-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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