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Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

NCT01204606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-03-12

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Arthroscopic rotator cuff repair with intraoperative periarticular injection

* 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.

PROCEDURE

Arthroscopic rotator cuff repair with non-injection of MMA drugs

* 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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chris H. Jo, M.D., Ph.D · Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01204606 on ClinicalTrials.gov