Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

NCT ID: NCT01204606

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MMA group

Group Type: EXPERIMENTAL

Arthroscopic rotator cuff repair with intraoperative periarticular injection

Intervention Type: 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.

Control group

Group Type: PLACEBO_COMPARATOR

Arthroscopic rotator cuff repair with non-injection of MMA drugs

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunchul Jo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris H. Jo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Joint and Spine Center; SMG-SNU Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRM-10-02

Identifier Type: -

Identifier Source: org_study_id