PainPhase 4ATR-2011NCT01304212
Effectiveness of Analgesia in Total Knee Arthroplasty
A Phase 4 study testing several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac, ropivacaine,morphine chloride,epinephrine,ketorolac and ropivacaine in people with Pain, run by Jose Antonio Bernia Gil at 1 site in Spain.
Trial summary
The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Pain
- What is being tested?
- several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac, ropivacaine,morphine chloride,epinephrine,ketorolac and ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Feb 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- intervention program for total knee arthroplasty
- ASA I, II, III
- over 65 years old
Who cannot join
- ASA > III
- patients who refuse the realization of technical loco-regional anesthesia
- presence of coagulopathy or impaired hemostatic function
- BMI > 35
- Serious intraoperative complications
- patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
- patients treated for chronic pain diagnosed processes, different knee osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty
The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.
- Conditions
- Pain
- Being tested
- several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac, ropivacaine,morphine chloride,epinephrine,ketorolac, ropivacaine, morphine ,ketorolac
- Keywords
- total knee arthroplasty, intraarticular infiltration, femoral block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
several drugs: morphine chloride,ropivacaine,epinephrine,ketorolacDrug
This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
ropivacaine,morphine chloride,epinephrine,ketorolacDrug
This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
ropivacaineDrug
The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)
morphine ,ketorolacDrug
ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| femoral block | Active comparator | Not described Receives: Drug: ropivacaine |
| local infiltration + femoral nerve block | Experimental | Combination of local infiltration with drugs and femoral nerve block Receives: Drug: morphine ,ketorolac |
| several drugs local infiltration | Active comparator | Not described Receives: Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac; Drug: ropivacaine,morphine chloride,epinephrine,ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Antonio Bernia Gil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Antonio Bernia Gil, Consorci Sanitari de Terrassa
- Investigators
- José Antonio Bernia Gil, MD, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304212
- Sponsor's protocol ID
- ATR-2011
- Acronym
- ATR-2011
- Status last verified
- Aug 2014
- First submitted
- 24 Feb 2011
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01304212
- Acronym / sponsor ID
- ATR-2011 / ATR-2011
- Conditions
- Pain
- Keywords
- total knee arthroplasty, intraarticular infiltration, femoral block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Jose Antonio Bernia GilUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Feb 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 compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| femoral block | Active comparator | Drug: ropivacaine |
| local infiltration + femoral nerve block | Experimental | Drug: morphine ,ketorolacCombination of local infiltration with drugs and femoral nerve block |
| several drugs local infiltration | Active comparator | Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac, Drug: ropivacaine,morphine chloride,epinephrine,ketorolac |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- intervention program for total knee arthroplasty
- ASA I, II, III
- over 65 years old
Key exclusion criteria (7 listed)
- ASA > III
- patients who refuse the realization of technical loco-regional anesthesia
- presence of coagulopathy or impaired hemostatic function
- BMI > 35
- Serious intraoperative complications
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 |
|---|---|---|
| several drugs: morphine chloride,ropivacaine,epinephrine,ketorolacThis technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline | Drug | several drugs local infiltration |
| ropivacaine,morphine chloride,epinephrine,ketorolacThis technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline | Drug | several drugs local infiltration |
| ropivacaineThe lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg) | Drug | femoral block |
| morphine ,ketorolacultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline. | Drug | local infiltration + femoral nerve block |
Primary outcome
postoperative pain
Time frame: 48 hours postoperatively
Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 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 28 Aug 2014.
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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.
José Antonio Bernia Gil, MD, PhD principal investigator
Consorci Sanitari de Terrassa
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 several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac, ropivacaine,morphine chloride,epinephrine,ketorolac and ropivacaine in people with Pain, run by Jose Antonio Bernia Gil at 1 site in Spain.
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 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 28 Aug 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 Spain. 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?
postoperative pain (time frame: 48 hours postoperatively). 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 28 Aug 2014.