Postoperative PainPhase 4TKANCT01898052
The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA
A Phase 4 study testing single anaesthetic drug and multimodal drug injection in people with Postoperative Pain, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- single anaesthetic drug and multimodal drug injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Mar 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- age 50-85 years old
Who cannot join
- unable to perform spinal anaesthesia
- history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
- cognitive function impairment
- renal impairment (creatinine clearance < 30 mL/min)
- liver impairment, gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
Thailand1 site
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.
Read the detailed description
Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.
In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.
- Conditions
- Postoperative Pain
- Being tested
- single anaesthetic drug, multimodal drug injection
- Keywords
- pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single anaesthetic drugDrug
Also called levobupivacaine, chirocaine
inject periarticular tissue of the knee after implantation
multimodal drug injectionDrug
Also called anaesthetic cocktail
inject periarticular tissue of the knee
| Study group | Role | What they receive |
|---|---|---|
| multimodal drug injection | Experimental | Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL Receives: Drug: multimodal drug injection |
| Single anaesthetic drug | Active comparator | Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg) Receives: Drug: single anaesthetic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
Measured: 48 hour after surgery
Secondary outcomes (1)
time to request analgesic drug
time when patient request morphine from patient controlled analgesia after intra-operative drug injection
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
- Investigators
- Supakit Kanitnate, M.D., Principal investigator, orthopaedics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898052
- Sponsor's protocol ID
- orthoTU03
- Other IDs
- orthoTU03
- Acronym
- TKA
- Status last verified
- Mar 2014
- First submitted
- 9 Jul 2013
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01898052
- Acronym / sponsor ID
- TKA / orthoTU03
- Conditions
- Postoperative Pain
- Keywords
- pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Jul 2013 (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 determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.
Detailed description
Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.
In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.
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 |
|---|---|---|
| multimodal drug injection | Experimental | Drug: multimodal drug injectionMultimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL |
| Single anaesthetic drug | Active comparator | Drug: single anaesthetic drugSingle anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- age 50-85 years old
Key exclusion criteria (5 listed)
- unable to perform spinal anaesthesia
- history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
- cognitive function impairment
- renal impairment (creatinine clearance < 30 mL/min)
- liver impairment, gastrointestinal bleeding
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 |
|---|---|---|
| single anaesthetic drugAlso: levobupivacaine, chirocaineinject periarticular tissue of the knee after implantation | Drug | Single anaesthetic drug |
| multimodal drug injectionAlso: anaesthetic cocktailinject periarticular tissue of the knee | Drug | multimodal drug injection |
Primary outcome
pain score
Time frame: 48 hour after surgery
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
1 secondary outcome
time to request analgesic drug
Time frame: 48 hours
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 Apr 2014.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Supakit Kanitnate, M.D. principal investigator
orthopaedics department
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 single anaesthetic drug and multimodal drug injection in people with Postoperative Pain, run by Thammasat 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 2 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 Apr 2014. 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. 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?
pain score (time frame: 48 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2014.