Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

NCT00992082 | Unknown DMC

• 1 other identifier: RAK-Spinal
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

Conditions

Osteoarthritis

Keywords

Postoperative pain; Local Infiltration Analgesia; Knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  The first 48 postoperative hours

Secondary Outcomes (6)

• Pain intensity

  0-3 months

• Knee function

  0-3 months

• Time to home readiness

  0-2 weeks

• Hospital stay

  0-2 weeks

• Side effects

  0-3 months

Study Arms (2)

Group LIA

ACTIVE COMPARATOR

Local Infiltration Analgesia

Drug: ropivacaine, ketorolac and epinephrine

Group M

ACTIVE COMPARATOR

Intrathecal morphine

Drug: morphine

Interventions

ropivacaine, ketorolac and epinephrine DRUG

Spinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

Group LIA

morphine DRUG

Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

Group M

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for total knee arthroplasty under spinal anesthesia.
• Aged 40-85 yrs.
• ASA physical status I-III and mobility indicating normal postoperative mobilization.

You may not qualify if:

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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Dept. of Orthopedic Surgery

Örebro, Örebro County, SE-70185, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Pain, Postoperative

Interventions

Ropivacaine; Ketorolac; Epinephrine; Morphine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Per Essving, MD

CONTACT

+4619602100; per.essving@orebroll.se

Kjell Axelsson, Professor

CONTACT

+4619602100; kjell.axelsson@orebroll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 9, 2009

Record last verified: 2009-10

Locations

SE (1)