Clinical Trials Directory

Trials / Completed

CompletedNCT01204606

Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
45 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREArthroscopic 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.
PROCEDUREArthroscopic 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.

Timeline

Start date
2010-09-01
Primary completion
2011-03-01
First posted
2010-09-17
Last updated
2013-03-12

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01204606. Inclusion in this directory is not an endorsement.