Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery May Decrease Pain for Several More Hours

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an additional injection of local anesthetic immediately prior to removal of the local anesthetic infiltration catheter on postoperative day one is effective in increasing pain reduction, patient satisfaction or outcome measures following total knee replacement (TKR). It is hypothesized that an additional injection of 30ml of .5% bupivacaine solution immediately before infiltration catheter removal will provide pain reduction, patient satisfaction and outcome measures equal or superior to catheter removal with no additional injection. Patients who are undergoing unilateral total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group.Patients in group one (treatment group) will receive a 30ml dose of .5% bupivacaine solution injected into the local anesthetic infiltration catheter immediately prior to its removal on postoperative day one. Patients in group two (control group) will receive no additional medication during local anesthetic infiltration catheter removal.

Detailed Description
-----------------
The purpose of this study is to determine if an additional injection of local anesthetic immediately prior to removal of the local anesthetic infiltration catheter on postoperative day one is effective in increasing pain reduction, patient satisfaction or outcome measures following total knee replacement (TKR). It is hypothesized that an additional injection of 30ml of .5% bupivacaine solution immediately before infiltration catheter removal will provide pain reduction, patient satisfaction and outcome measures equal or superior to catheter removal with no additional injection. The target enrollment for this study is 50 participants, 25 in each of groups one and two. Patients who are undergoing unilateral total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. Upon agreement, patient's consent will be obtained and they will be randomly assigned to a treatment group. Patients in group one (treatment group) will receive a 30ml dose of 0.5% bupivacaine solution injected into the local anesthetic infiltration catheter immediately prior to its removal on postoperative day one. Patients in group two (control group) will receive no additional medication during local anesthetic infiltration catheter removal. Members of both groups will be asked to complete Visual Analog Scale (VAS) pain and satisfaction surveys and also to track daily narcotic pain medication consumption during the first week postoperatively. Measures of swelling in the operative knee will be collected for members of both groups at the first routine postoperative appointment approximately one week after surgery. Swelling will be measured using a Perometer which calculates the total volume of the extremity in cubic centimeters (Pero-System, Wuppertal, Germany). Proprioception will be measured using a SD Balancer (Biodex Medical Systems, Shirley, NY) which calculates the the overall stability index (OSI) and compares it to age standardized data. Quadriceps strength using a handheld dynamometer. Outcome measures will be collected for members of both groups prior to surgery and at the second routine postoperative appointment between 6 weeks after surgery. Swelling will be also measured at the first post-operative visit 1 week after surgery. These data measures, as well as any complications will be recorded and used for analysis at the completion of the study. The Principal Investigator (PI) will review all pain, satisfaction, narcotic usage and proprioception data on a weekly basis with the research assistant (RA) as it is collected. These checks will help to ensure validity and patient safety. Privacy and confidentially will be assured by using codes as deidentifiers in place of identifying information on any data sheets used in analysis. Data which identifies the patient will be made available only to investigators and stored only in a private folder on department computers protected with a firewall. No data will be shared outside of Partners. Adverse events will be promptly reported to the PHRC as per PHRC rules.

Official Title
-----------------
Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery

Conditions
-----------------
Arthroplasty, Knee, Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Undergoing unilateral knee replacement If female, not pregnant Agree to participate in the follow-up appointment Understand and sign the informed consent form Exclusion Criteria: • Bilateral TKA planned Use of narcotic medication before surgery Any other surgery within the three months prior to TKR Inflammatory arthritis Any chronic pain conditions or problems, including but not limited to chronic back pain, fibromyalgia or multiple sclerosis Osteoarthritis of the non-operative knee Osteoarthritis of one or both hips

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We randomized 50 patients undergoing TKA at one institution into two groups. Group 1, 25 patients, received a postoperative intra-articular catheter in combination with injection of 30 ml of 0.5% Marcaine the day after surgery before removal. Group 2, 25 patients, received no pain catheter. Both groups received intraoperative pericapsular injection and postoperative pain medication. We measured pain scores using the Visual Analog Scale (VAS) and recorded narcotic medication consumption in morphine milligram equivalents (mgs).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection<br>Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal | Drug: Bupivacaine<br>* Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.<br>* Other names: marcaine;|
| Active Comparator: No Injection<br>Will not receive injection of bupivacaine prior to catheter removal | Other: No Intervention<br>* No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessed Using the VAS 0-10 Pain Scale | Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit. | 2 days | 
| Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription. | 7 days | 
| Swelling Measured Using a Perometer | Swelling in the affected TKR joint, as measured by a perometer. | 7 days | 
| Proprioception Measured Using a SD Balancer | Proprioception measured after surgery, as measured by an SD balancer. | 7 days | 
| Quadriceps Strength Measured Using a Biodex Handheld Dynamometer | Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Arthroplasty, Bupivacaine, Anesthetics, Local