Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty

NCT00653926 | Completed DMC

• 1 other identifier: RAK-mini
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  April, 2007

Secondary Outcomes (1)

• 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.

  September, 2007

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: ropivacaine, ketorelac and epinephrine

P

PLACEBO COMPARATOR

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

Drug: saline

Interventions

ropivacaine, ketorelac and epinephrine DRUG

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.

A

saline DRUG

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.

P

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for unicompartmental knee arthroplasty
• Aged 20-80 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 and Anesthesia and Intensive Care

Örebro, SE-70185, Sweden

Location

Related Publications (1)

• Essving P, Axelsson K, Kjellberg J, Wallgren O, Gupta A, Lundin A. Reduced hospital stay, morphine consumption, and pain intensity with local infiltration analgesia after unicompartmental knee arthroplasty. Acta Orthop. 2009 Apr;80(2):213-9. doi: 10.3109/17453670902930008.

  PMID: 19404806 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

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; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kjell Axelsson, Prof.

  Orebro University Hospital, Orebro, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: September 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 7, 2008

Record last verified: 2008-04

Locations

SE (1)