SurgeryPhase 4NCT02239497
Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb
A Phase 4 study testing Femoral block by ultrasound and neurostimulation and Intravenous analgesia in people with Surgery, run by Hospital Central Dr. Luis Ortega at 1 site in Venezuela.
Trial summary
Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Femoral block by ultrasound and neurostimulation and Intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVenezuela
- Study dates
- Mar 2013to Sep 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia
Who cannot join
- Patients with any anesthetic or surgical complication
- Patients with neuromuscular diseases
- Allergy to any of the drugs used in the study
- Inability to understand and use a pain scale
- Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Servicio de Anestesiologia Hospital "Dr. Luis Ortega"
Porlamar, Nueva Esparta, 6301
About this study
Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4
- Conditions
- Surgery
- Being tested
- Femoral block by ultrasound and neurostimulation, Intravenous analgesia
- Keywords
- postoperatory pain, orthopaedic surgery, femoral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral block by ultrasound and neurostimulationProcedure or surgery
Intravenous analgesiaDrug
Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia
| Study group | Role | What they receive |
|---|---|---|
| femoral block by US and NE and intravenous analgesia | Experimental | preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia Receives: Procedure: Femoral block by ultrasound and neurostimulation; Drug: Intravenous analgesia |
| Intravenous analgesia | Experimental | Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia Receives: Drug: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperatory EVA values and need for rescue analgesia with IV morphine
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Dr. Luis Ortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
- Investigators
- Beatriz S Arismendi Gomez, MD, Principal investigator, Hospital "Dr Luis Ortega"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239497
- Sponsor's protocol ID
- Femoral Block
- Status last verified
- Sep 2014
- First submitted
- 7 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb
- ClinicalTrials.gov ID
- NCT02239497
- Acronym / sponsor ID
- Femoral Block
- Conditions
- Surgery
- Keywords
- postoperatory pain, orthopaedic surgery, femoral block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Central Dr. Luis OrtegaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 12 Sep 2014 (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.
Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral block by US and NE and intravenous analgesia | Experimental | Procedure: Femoral block by ultrasound and neurostimulation, Drug: Intravenous analgesiapreincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia |
| Intravenous analgesia | Experimental | Drug: Intravenous analgesiaIntravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia
Key exclusion criteria (5 listed)
- Patients with any anesthetic or surgical complication
- Patients with neuromuscular diseases
- Allergy to any of the drugs used in the study
- Inability to understand and use a pain scale
- Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block
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 |
|---|---|---|
| Femoral block by ultrasound and neurostimulation | Procedure or surgery | femoral block by US and NE and intravenous analgesia |
| Intravenous analgesiaIntravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia | Drug | Intravenous analgesia, femoral block by US and NE and intravenous analgesia |
Primary outcome
Postoperatory EVA values and need for rescue analgesia with IV morphine
Time frame: 24 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 12 Sep 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.
Beatriz S Arismendi Gomez, MD principal investigator
Hospital "Dr Luis Ortega"
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 Femoral block by ultrasound and neurostimulation and Intravenous analgesia in people with Surgery, run by Hospital Central Dr. Luis Ortega at 1 site in Venezuela.
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 1 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 12 Sep 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 Venezuela. 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?
Postoperatory EVA values and need for rescue analgesia with IV morphine (time frame: 24 hours). 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 12 Sep 2014.