Pain Clinical Trial
Official title:
Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery
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.
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.
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