Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty - Full Text View

Purpose

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: ropivacaine Drug: adrenaline Drug: ketorolac Drug: morphine Drug: fentanyl Drug: bupivacaine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Morphine sulfate Racepinephrine hydrochloride Racepinephrine Fentanyl Fentanyl citrate Bupivacaine hydrochloride Bupivacaine Ketorolac Ketorolac tromethamine Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

Pain at Rest (VAS) [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.

Secondary Outcome Measures:

Opioid Use [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Time to Readiness for Discharge [ Time Frame: up to 10 days postoperative ] [ Designated as safety issue: No ]
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.

Enrollment:	102
Study Start Date:	November 2007
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LIA IV Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine	Drug: ropivacaine intraoperative and 1. postoperative day Other Name: Naropin Drug: adrenaline intraoperative LIA (IV and IA) and continuous EDA Other Names: Adrenalin (epinephrine) Drug: ketorolac intraoperative and 1. postoperative day Other Name: Toradol Drug: morphine intraoperative Other Name: Morfin
Experimental: LIA IA Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine	Drug: ropivacaine intraoperative and 1. postoperative day Other Name: Naropin Drug: adrenaline intraoperative LIA (IV and IA) and continuous EDA Other Names: Adrenalin (epinephrine) Drug: ketorolac intraoperative and 1. postoperative day Other Name: Toradol Drug: morphine intraoperative Other Name: Morfin
Active Comparator: EDA standard continuous epidural analgesia	Drug: adrenaline intraoperative LIA (IV and IA) and continuous EDA Other Names: Adrenalin (epinephrine) Drug: fentanyl continuous postoperatively Other Name: Fentanyl Drug: bupivacaine continuous postoperatively Other Name: Marcain

Detailed Description:

Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients at least 18 years of age
scheduled for elective total knee arthroplasty
ASA I-III
signed written informed consent

Exclusion Criteria:

age < 18
ASA > III
moderate or severe cardiac disease, bronchial asthma
allergy against ropivacaine, ketorolac or morphine
analgetic abuse
pregnancy or nursing women
severe psychiatric disease
moderate to severe dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562627

Locations

Norway
Asker and Baerum Hospital
Rud, Norway, 1309

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Principal Investigator:

Ulrich J Spreng, MD

Asker and Baerum Hospital

More Information

No publications provided by Asker & Baerum Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Spreng UJ, Dahl V, Hjall A, Fagerland MW, Ræder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. Epub 2010 Aug 24.

Responsible Party:	Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00562627 History of Changes
Other Study ID Numbers:	2007-003030-41, EudraCT 2007-003030-41, REK 1.2007.1603
Study First Received:	November 21, 2007
Results First Received:	May 24, 2011
Last Updated:	August 5, 2011
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

osteoarthritis
knee arthroplasty
local infiltration analgesia
TKA

epidural analgesia
operation
surgery

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epinephrine
Epinephryl borate
Bupivacaine
Fentanyl
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Adrenergic beta-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics

ClinicalTrials.gov processed this record on May 16, 2013