Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01204606

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale(VAS) for Pain [postoperative 5 hours]

Secondary Outcome Measures

Postoperative narcotic consumption [every 6 hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyunchul Jo, Assistant Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01204606

Other Study ID Numbers:

BRM-10-02

First Posted:

Sep 17, 2010

Last Update Posted:

Mar 12, 2013

Last Verified:

Mar 1, 2013

Additional relevant MeSH terms:

Rotator Cuff Injuries

Study Results

No Results Posted as of Mar 12, 2013