Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204606
• Other study ID #: BRM-10-02
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: March 11, 2013
• Start date: September 2010

Study information

• Verified date: March 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Joint and Spine Center; SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale(VAS) for Pain		postoperative 5 hours	No
Secondary	Postoperative narcotic consumption		every 6 hours after surgery	No