Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

NCT01204606 | Completed

• 1 other identifier: BRM-10-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale(VAS) for Pain

  postoperative 5 hours

Secondary Outcomes (1)

• Postoperative narcotic consumption

  every 6 hours after surgery

Study Arms (2)

MMA group

EXPERIMENTAL

Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection

Control group

PLACEBO COMPARATOR

Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs

Interventions

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.

MMA group

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.

Control group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rotator cuff tear
• arthroscopic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint and Spine Center; SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Chris H. Jo, M.D., Ph.D

  Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

KR (1)