Arthroplasty, KneeNCT02420951
Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery May Decrease Pain for Several More Hours
A study testing Bupivacaine in people with Arthroplasty, Knee and Pain, run by Brigham and Women's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Knee, Pain
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2015to 9 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Arthroplasty, Knee, Pain
- Being tested
- Bupivacaine, No Intervention
- Keywords
- Knee, Arthroplasty, Bupivacaine, Anesthetics, Local
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called marcaine
Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
No InterventionOther
No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
| Study group | Role | What they receive |
|---|---|---|
| Injection | Experimental | Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Receives: Drug: Bupivacaine |
| No Injection | Active comparator | Will not receive injection of bupivacaine prior to catheter removal Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 7 days
Swelling Measured Using a Perometer
Swelling in the affected TKR joint, as measured by a perometer.
Measured: 7 days
Proprioception Measured Using a SD Balancer
Proprioception measured after surgery, as measured by an SD balancer.
Measured: 7 days
Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"
Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start5 Oct 2015
- Primary completion22 Mar 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, KneeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Fitz, Brigham and Women's Hospital
- Investigators
- Wolfgang Fitz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420951
- Sponsor's protocol ID
- Injection after total knee
- Status last verified
- Dec 2017
- First submitted
- 28 Jan 2015
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21.
PubMed 23516031Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16.
PubMed 24911869Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20.
PubMed 23783531Jiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y. The efficacy of periarticular multimodal drug injection for postoperative pain management in total knee or hip arthroplasty. J Arthroplasty. 2013 Dec;28(10):1882-7. doi: 10.1016/j.arth.2013.06.031. Epub 2013 Aug 1.
PubMed 23910819National Center for Health Statistics. National Hospital Discharge Survey, 2010. Hyattsville, Maryland: Public Health Service. 2010.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02420951
- Acronym / sponsor ID
- Injection after total knee
- Conditions
- Arthroplasty, Knee, Pain
- Keywords
- Knee, Arthroplasty, Bupivacaine, Anesthetics, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 22 Mar 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Injection | Experimental | Drug: BupivacaineWill receive injection of 30ml of .5% bupivacaine solution prior to catheter removal |
| No Injection | Active comparator | Other: No InterventionWill not receive injection of bupivacaine prior to catheter removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: marcaineInjection of local anesthetic immediately prior to catheter removal, 24 hours postop. | Drug | Injection |
| No InterventionNo injection of local anesthetic immediately prior to catheter removal, 24 hours postop. | Other | No Injection |
Primary outcome
Pain Assessed Using the VAS 0-10 Pain Scale
Time frame: 7 days
Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.
5 secondary outcomes
Pain Med Consumption Assessed Using Questionnaire/Hospital Records
Time frame: 2 days
Pain Med Consumption Assessed Using Questionnaire/Hospital Records
Time frame: 7 days
Swelling Measured Using a Perometer
Time frame: 7 days
Proprioception Measured Using a SD Balancer
Time frame: 7 days
Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23516031Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21.
- Background: PubMed 24911869Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16.
- Background: PubMed 23783531Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20.
- Background: PubMed 23910819Jiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y. The efficacy of periarticular multimodal drug injection for postoperative pain management in total knee or hip arthroplasty. J Arthroplasty. 2013 Dec;28(10):1882-7. doi: 10.1016/j.arth.2013.06.031. Epub 2013 Aug 1.
- BackgroundNational Center for Health Statistics. National Hospital Discharge Survey, 2010. Hyattsville, Maryland: Public Health Service. 2010.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty, Knee
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Fitz, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine in people with Arthroplasty, Knee and Pain, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessed Using the VAS 0-10 Pain Scale (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420951, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.