Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

Study Overview
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Brief Summary
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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.

Official Title
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Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection
* Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMA group<br> | Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection<br>* 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.<br>|
| Placebo Comparator: Control group<br> | Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale(VAS) for Pain |  | postoperative 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative narcotic consumption |  | every 6 hours after surgery |