Pain, PostoperativePhase 4NCT01364194
Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
A Phase 4 study testing 0.25% Bupivacaine and 0.9% normal saline in people with Pain, Postoperative and Arthropathy of Knee Joint, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pain, Postoperative, Arthropathy of Knee Joint
- What is being tested?
- 0.25% Bupivacaine and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
- BMI between 20-35
- having a full understanding of the question in this trial
Who cannot join
- allergy to NSAIDs, Acetaminophen, Bupivacaine
- blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min
- abnormal liver function
- previous surgery on the knee undergoing total knee replacement
- patient could not receive spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial
The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.
Read the detailed description
Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.
- Conditions
- Pain, Postoperative, Arthropathy of Knee Joint
- Being tested
- 0.25% Bupivacaine, 0.9% normal saline
- Keywords
- Post operative pain, Total knee replacement, Total knee arthroplasty, Bupivacaine, Periarticular injection, Placebo, Morphine consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% BupivacaineDrug
Also called Marcaine
Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.
0.9% normal salineDrug
Also called Isotonic saline
Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
| Study group | Role | What they receive |
|---|---|---|
| 0.25% Bupivacaine | Active comparator | Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure. Receives: Drug: 0.25% Bupivacaine |
| 0.9% normal saline | Placebo comparator | Periarticular injection with 20 ml of 0.9% normal saline before wound closure. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Measure by Visual analog scale scores and morphine consumption
Measured: 96 hour post operation
Secondary outcomes (1)
Complication of Morphine consumption
nausea, pruritis, urinary retention and constipation
Measured: 96 hour post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Investigators
- Keerati Chareancholvanich, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364194
- Sponsor's protocol ID
- 516/2552(EC3)
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement surgeries and implications for public health, 1990-2000. Public Health Rep. 2005 May-Jun;120(3):278-82. doi: 10.1177/003335490512000310.
PubMed 16134568Akyol O, Karayurt O, Salmond S. Experiences of pain and satisfaction with pain management in patients undergoing total knee replacement. Orthop Nurs. 2009 Mar-Apr;28(2):79-85. doi: 10.1097/NOR.0b013e3181945f62.
PubMed 19339865Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.
PubMed 17464603Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
PubMed 16452738Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
PubMed 17823012Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PubMed 16651569
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01364194
- Acronym / sponsor ID
- 516/2552(EC3)
- Conditions
- Pain, Postoperative, Arthropathy of Knee Joint
- Keywords
- Post operative pain, Total knee replacement, Total knee arthroplasty, Bupivacaine, Periarticular injection, Placebo, Morphine consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
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 evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.
Detailed description
Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25% Bupivacaine | Active comparator | Drug: 0.25% BupivacainePeriarticular injection with 20 ml of 0.25% bupivacaine before wound closure. |
| 0.9% normal saline | Placebo comparator | Drug: 0.9% normal salinePeriarticular injection with 20 ml of 0.9% normal saline before wound closure. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
- BMI between 20-35
- having a full understanding of the question in this trial
Key exclusion criteria (5 listed)
- allergy to NSAIDs, Acetaminophen, Bupivacaine
- blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min
- abnormal liver function
- previous surgery on the knee undergoing total knee replacement
- patient could not receive spinal anesthesia
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 |
|---|---|---|
| 0.25% BupivacaineAlso: MarcainePeriarticular injection with 20 ml of 0.25% bupivacaine before wound closure. | Drug | 0.25% Bupivacaine |
| 0.9% normal salineAlso: Isotonic salinePeriarticular injection with 20 ml of 0.9% normal saline before wound closure. | Drug | 0.9% normal saline |
Primary outcome
Post operative pain
Time frame: 96 hour post operation
Measure by Visual analog scale scores and morphine consumption
1 secondary outcome
Complication of Morphine consumption
Time frame: 96 hour post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Background: PubMed 16134568Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement surgeries and implications for public health, 1990-2000. Public Health Rep. 2005 May-Jun;120(3):278-82. doi: 10.1177/003335490512000310.
- Background: PubMed 19339865Akyol O, Karayurt O, Salmond S. Experiences of pain and satisfaction with pain management in patients undergoing total knee replacement. Orthop Nurs. 2009 Mar-Apr;28(2):79-85. doi: 10.1097/NOR.0b013e3181945f62.
- Background: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Background: PubMed 17464603Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.
- Background: PubMed 16452738Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
- Background: PubMed 17823012Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
- Background: PubMed 16651569Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
- Total knee replacementLink provided by the sponsor.
- Bupivacaine informationLink provided by the sponsor.
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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.
Keerati Chareancholvanich, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.25% Bupivacaine and 0.9% normal saline in people with Pain, Postoperative and Arthropathy of Knee Joint, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 5 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 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post operative pain (time frame: 96 hour post operation). 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 NCT01364194, which also lists 7 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 2 Jun 2011.