Local Infiltration Analgesia Following Total Knee Arthroplasty

NCT ID: NCT00799175

Last Updated: 2008-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-09-30

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 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.

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. 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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Local infiltration analgesia; Knee arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 Group A(Active)

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

Group Type: ACTIVE_COMPARATOR

ropivacaine, ketorolac and epinephrine

Intervention Type: DRUG

In Group A, 400 mg ropivicaine, 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 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, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

2 Group P (Placebo)

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

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

In Group P (placebo) no injections were given intraoperatively. 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.

Interventions

ropivacaine, ketorolac and epinephrine

In Group A, 400 mg ropivicaine, 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 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, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

Intervention Type: DRUG

saline

In Group P (placebo) no injections were given intraoperatively. 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Orebro, Orebro, Sweden

Principal Investigators

Kjell Axelsson, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Orebro, Sweden

Locations

University Hospital Orebro

Örebro, , Sweden

University Hospital Orebro

Örebro, , Sweden

Countries

Sweden

Other Identifiers

RAK-total

Identifier Type: -

Identifier Source: org_study_id