Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)

Region Örebro County

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: saline; Drug: ropivacaine, ketorolac and epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00799175

RAK-total

Details and patient eligibility

About

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 morphine consumption. Secondary end-points are hospital stay, 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 3 months after surgery.

Full 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. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

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 morphine consumption. Secondary end-points are hospital stay, 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 3 months after surgery.

Enrollment: 48 patients

Sex: Female

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for total knee arthroplasty
• Aged 20-85 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

1 Group A(Active)

Active Comparator group

Description:

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

Treatment:

Drug: ropivacaine, ketorolac and epinephrine

2 Group P (Placebo)

Placebo Comparator group

Description:

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

Treatment:

Drug: saline