-Postoperative PainNCT02056145
Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery
A study testing LFCNB and FNB in people with -Postoperative Pain, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- -Postoperative Pain
- What is being tested?
- LFCNB and FNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Aug 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hip arthroplasty with posterolateral approach.
Who cannot join
- Known allergy to levobupivacaine and / or piritramide
- Known neurological disorders or peripheral neuropathies
- Existing drug or alcohol abuse
- Chronic use of pain medication (> started 3 months ago) not related to the hip suffering
- Coagulopathy (international normalized ratio) > 1.4
- Thrombocytopenia <70,000 platelets,
Show all 11Show fewer
- Dementia
- Pregnancy
- Local infection hip
- Hepatic and / or renal impairment
- BMI> 45.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.
Read the detailed description
Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.
- Conditions
- -Postoperative Pain
- Being tested
- LFCNB, FNB
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFCNBProcedure or surgery
LFCNB - Normal Saline solution 10 cc
FNBProcedure or surgery
FNB - Normal saline solution 10 cc
LFCNBProcedure or surgery
LFCNB - Chirocaine 0.25%, 20 cc
FNBProcedure or surgery
FNB - Chirocaine 0.25%, 20 cc
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%. Receives: Procedure: LFCNB; Procedure: FNB |
| Group 2 | Active comparator | Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%. Receives: Procedure: LFCNB; Procedure: FNB |
| Group 3 | Active comparator | Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution. Receives: Procedure: LFCNB; Procedure: FNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of opioids
The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure.
Measured: 48 hours
Secondary outcomes (1)
Visual analog scale (VAS) scores (0-10)
The secondary outcome measure will be pain scores (VAS 0-10). Those scores will be measured en documented at the fixed intervals during the first 48 hours post-procedure.
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 posted5 Feb 2014 (estimated)
- Study startOct 2011
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
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.
- More trials run by University Hospital, AntwerpThe 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
- Investigators
- Sultan TEMURZIEV, MD, Principal investigator, Department of Anesthesiology, Antwerp University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056145
- Sponsor's protocol ID
- 11/36/241
- Status last verified
- Jul 2014
- First submitted
- 4 Feb 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery
- ClinicalTrials.gov ID
- NCT02056145
- Acronym / sponsor ID
- 11/36/241
- Conditions
- -Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 5 Feb 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.
Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.
Detailed description
Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Procedure: LFCNB, Procedure: FNBGroup 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%. |
| Group 2 | Active comparator | Procedure: LFCNB, Procedure: FNBGroup 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%. |
| Group 3 | Active comparator | Procedure: LFCNB, Procedure: FNBGroup 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary hip arthroplasty with posterolateral approach.
Key exclusion criteria (11 listed)
- Known allergy to levobupivacaine and / or piritramide
- Known neurological disorders or peripheral neuropathies
- Existing drug or alcohol abuse
- Chronic use of pain medication (> started 3 months ago) not related to the hip suffering
- Coagulopathy (international normalized ratio) > 1.4
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 |
|---|---|---|
| LFCNBLFCNB - Normal Saline solution 10 cc | Procedure or surgery | Group 1, Group 2 |
| FNBFNB - Normal saline solution 10 cc | Procedure or surgery | Group 1 |
| LFCNBLFCNB - Chirocaine 0.25%, 20 cc | Procedure or surgery | Group 3 |
| FNBFNB - Chirocaine 0.25%, 20 cc | Procedure or surgery | Group 2, Group 3 |
Primary outcome
Use of opioids
Time frame: 48 hours
The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure.
1 secondary outcome
Visual analog scale (VAS) scores (0-10)
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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.
Sultan TEMURZIEV, MD principal investigator
Department of Anesthesiology, Antwerp University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LFCNB and FNB in people with -Postoperative Pain, run by University Hospital, Antwerp at 1 site in Belgium.
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 11 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: status not confirmed, as of the sponsor's last update on 2 Jul 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 Belgium. 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.
Are results available for this study?
Results are not available in the source record.
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?
Use of opioids (time frame: 48 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 2 Jul 2014.