Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair with intraoperative periarticular injection
Arthroscopic rotator cuff repair with non-injection of MMA drugs
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear
Eligibility Criteria
Inclusion Criteria:
- rotator cuff tear
- arthroscopic surgery
Exclusion Criteria:
- age<45 or >85
- allergies to the drugs used in the study
- acute trauma history
- history of renal disease
- history of hepatic disease
- osteoarthritis or rheumatic arthritis
- systemic condition with chronic pain
- history of infection
- could not understand the questions
- rotator cuff tear treated by the open technique, by debridement only
Sites / Locations
- Joint and Spine Center; SMG-SNU Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MMA group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale(VAS) for Pain
Secondary Outcome Measures
Postoperative narcotic consumption
Full Information
NCT ID
NCT01204606
First Posted
September 16, 2010
Last Updated
March 11, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01204606
Brief Title
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
Official Title
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair.
Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMA group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair with intraoperative periarticular injection
Intervention Description
Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4 or 5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repaired of rotator cuff tear was done with suture anchors.
Mixed MMA drugs(ropivacaine 300mg;40ml, morphine 10mg;1ml, cefotetan 1g; dilution to ropivacaine, epinephrine 0.3mg;0.3ml, total volume:41.3ml) and sodium hyaluronate 20mg;2ml were injected divisionally periarticular area; intra-articular(sodium hyaluronate 20ml;2ml + 10.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.
Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair with non-injection of MMA drugs
Intervention Description
Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4 or 5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repaired of rotator cuff tear was done with suture anchors.
43.3ml of saline was injected divisionally periarticular area; intra-articular(12.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.
Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.
Primary Outcome Measure Information:
Title
Visual Analogue Scale(VAS) for Pain
Time Frame
postoperative 5 hours
Secondary Outcome Measure Information:
Title
Postoperative narcotic consumption
Time Frame
every 6 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
rotator cuff tear
arthroscopic surgery
Exclusion Criteria:
age<45 or >85
allergies to the drugs used in the study
acute trauma history
history of renal disease
history of hepatic disease
osteoarthritis or rheumatic arthritis
systemic condition with chronic pain
history of infection
could not understand the questions
rotator cuff tear treated by the open technique, by debridement only
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris H. Jo, M.D., Ph.D
Organizational Affiliation
Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint and Spine Center; SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
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Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
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