Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty

NCT ID: NCT00803348

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-10-31

Brief Summary

Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a femoral nerve block as part of their anesthetic care. Some centers administer the block with a single shot of local anesthetic, which wears off several hours after surgery. Other centers administer the block with a single shot followed by continuous infusion of local anesthetic, typically for 2 to 5 days after surgery. The latter method, though good for pain control, may result in decreased mobility (while the anesthetic is still active), longer hospital stays, and greater risk of falls.

This study will see if using a lower concentration of local anesthetic for the continuous femoral nerve block or only the initial single-shot dose will result in increased mobility and shorter hospital stays.

Conditions

Knee Arthroplasty

Study Design

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

Study Groups

1

Initial Bolus dose of 0.2% ropivicaine followed by 0.2% ropivicaine infusion until day 2 post-op

Group Type: ACTIVE_COMPARATOR

Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2

Intervention Type: DRUG

Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2

2

Initial Bolus dose of 0.2% ropivicaine followed by 0.1% ropivicaine infusion until day 2 post-op

Group Type: EXPERIMENTAL

Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2

Intervention Type: DRUG

Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2

3

Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op

Group Type: PLACEBO_COMPARATOR

Saline control

Intervention Type: DRUG

Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2

Interventions

Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2

Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2

Intervention Type: DRUG

Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2

Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2

Intervention Type: DRUG

Saline control

Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ASA physical status I-III

2. 18-85 years of age, inclusive

3. Able to communicate in English sufficiently to participate in the study

4. Able to walk 30 metres without stopping prior to surgery

Exclusion Criteria

1. Intended discharge to in-patient rehabilitation facility

2. Patient refusal of FNB or spinal anesthetic or sciatic nerve block

3. Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal)

4. Significant peripheral neuropathy or neurological disorder affecting the lower extremity

5. Contraindication to a component of multi-modal analgesia

6. Pregnancy

7. History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively)

8. History of significant cognitive or psychiatric condition that may affect patient assessment

9. Inability to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Albrecht E, Morfey D, Chan V, Gandhi R, Koshkin A, Chin KJ, Robinson S, Frascarolo P, Brull R. Single-injection or continuous femoral nerve block for total knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1384-93. doi: 10.1007/s11999-013-3192-3.

Reference Type: DERIVED

PMID: 23928707 (View on PubMed)

Other Identifiers

08-0895-B

Identifier Type: -

Identifier Source: org_study_id