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

Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02420951

Enrollment

Registered

2015-04-20

Start date

2015-10-05

Completion date

2016-12-09

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Knee, Pain

Keywords

Knee, Arthroplasty, Bupivacaine, Anesthetics, Local

Brief summary

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.

Interventions

DRUGBupivacaine

Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.

OTHERNo Intervention

No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pain Med Consumption Assessed Using Questionnaire/Hospital Records	2 days	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.
Swelling Measured Using a Perometer	7 days	Swelling in the affected TKR joint, as measured by a perometer.
Proprioception Measured Using a SD Balancer	7 days	Proprioception measured after surgery, as measured by an SD balancer.
Quadriceps Strength Measured Using a Biodex Handheld Dynamometer	7 days	Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer.

Participant flow

Participants by arm

Arm	Count
Injection Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	25
No Injection Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.	25
Total	50

Baseline characteristics

Characteristic	Injection	No Injection	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	18 Participants	16 Participants	34 Participants
Age, Categorical Between 18 and 65 years	7 Participants	9 Participants	16 Participants
Age, Continuous	68.96 years	66.44 years	67.7 years
Sex: Female, Male Female	15 Participants	14 Participants	29 Participants
Sex: Female, Male Male	10 Participants	11 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 25
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Population: Data were not collected.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026