N/A N=50 Randomized Treatment

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

Arthroplasty, Knee · Pain

Bottom Line

View on ClinicalTrials.gov: NCT02420951 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Pain Assessed Using the VAS 0-10 Pain Scale — 2.763; 2.483 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bupivacaine (Drug); No Intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Assessed Using the VAS 0-10 Pain Scale	2.763; 2.483	—
SECONDARY Pain Med Consumption Assessed Using Questionnaire/Hospital Records	—	—
SECONDARY Pain Med Consumption Assessed Using Questionnaire/Hospital Records	—	—
SECONDARY Swelling Measured Using a Perometer	—	—
SECONDARY Proprioception Measured Using a SD Balancer	—	—
SECONDARY Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02420951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.