Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty - Full Text View

Sponsored by:	University Hospital Orebro
Information provided by:	University Hospital Orebro
ClinicalTrials.gov Identifier:	NCT00653926

Purpose

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 6 months after surgery.

Condition	Intervention
Postoperative Pain	Drug: ropivacaine, ketorelac and epinephrine Drug: saline

MedlinePlus related topics: Knee Replacement

Drug Information available for: Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Ketorolac Ketorolac tromethamine Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:

The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. [ Time Frame: April, 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery. [ Time Frame: September, 2007 ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	September 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Group A (Active) receives a multimodal injection intra- and postoperatively	Drug: ropivacaine, ketorelac and epinephrine In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
P: Placebo Comparator Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively	Drug: saline In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.

Arms

Assigned Interventions

A: Active Comparator

Group A (Active) receives a multimodal injection intra- and postoperatively

Drug: ropivacaine, ketorelac and epinephrine

In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

P: Placebo Comparator

Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively

Drug: saline

In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.

Detailed Description:

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients scheduled for unicompartmental knee arthroplasty
Aged 20-80 yrs.
ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria:

Known allergy or intolerance to one of the study drugs
Serious liver-, heart- or renal decease
Rheumatoid arthritis
Chronic pain or bleeding disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653926

Locations

Sweden
Dept. of Orthopedic Surgery and Anesthesia and Intensive Care
Orebro, Sweden, SE-70185

Sponsors and Collaborators

University Hospital Orebro

Investigators

Principal Investigator:

Kjell Axelsson, Prof.

Orebro University Hospital, Orebro, Sweden

More Information

Responsible Party:	Dept. of Anaestesiology, Örebro University, Örebro, Sweden ( Professor Kjell Axelsson )
Study ID Numbers:	RAK-mini
Study First Received:	April 2, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00653926
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:

Postoperative pain
Local infiltration analgesia
Knee arthroplasty
Postoperative pain management following unicompartmental knee arthroplasty

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Ropivacaine
Ketorolac

Pain
Epinephrine
Ketorolac Tromethamine
Pain, Postoperative

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Anti-Asthmatic Agents
Cardiovascular Agents

Anesthetics, Local
Pharmacologic Actions
Adrenergic Agonists
Pathologic Processes
Mydriatics
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009