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Completed

NCT Number: NCT01204606

Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

* 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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint and Spine Center; SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic rotator cuff repair with intraoperative periarticular injection

Procedure
  • 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.

Arthroscopic rotator cuff repair with non-injection of MMA drugs

Procedure
  • 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 outcomes

  1. Visual Analogue Scale(VAS) for Pain

    Time frame: postoperative 5 hours

Secondary outcomes

  1. Postoperative narcotic consumption

    Time frame: every 6 hours after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Sep 17, 2010
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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