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Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01204606
First received: September 16, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose
  • 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.

Condition Intervention
Rotator Cuff Tear
 Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection
Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Visual Analogue Scale(VAS) for Pain [ Time Frame: postoperative 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative narcotic consumption [ Time Frame: every 6 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2010
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMA group 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.
Placebo Comparator: Control group 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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204606

Locations
Korea, Republic of
Joint and Spine Center; SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chris H. Jo, M.D., Ph.D Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center
  More Information

No publications provided

Responsible Party: Hyunchul Jo, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01204606     History of Changes
Other Study ID Numbers: BRM-10-02
Study First Received: September 16, 2010
Last Updated: March 11, 2013
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013