Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

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

• 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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection; Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Joint and Spine Center; SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: BRM-10-02