Onset and Duration of Sensory and Motor Block of Femoral Nerve,Phase 4NCT01964040
Perineural Dexmedetomidine and Femoral Nerve Block
A Phase 4 study testing peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block in people with Onset and Duration of Sensory and Motor Block of Femoral Nerve, and Visual Analogue Pain Scores,, run by Cairo University at 1 site in Egypt.
Trial summary
The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Onset and Duration of Sensory and Motor Block of Femoral Nerve,, Visual Analogue Pain Scores,, Time to First Request of Rescue Analgesics,
- What is being tested?
- peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2013to Jan 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients with ASA physical status I or II, scheduled for diagnostic knee arthroscopy
Who cannot join
- Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Anesthesia department-faculty of medicine-Cairo University
Cairo, Cairo Governorate, 02
About this study
Official title: Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.
- Conditions
- Onset and Duration of Sensory and Motor Block of Femoral Nerve,, Visual Analogue Pain Scores,, Time to First Request of Rescue Analgesics,, Total Morphine Consumption in 24 Hours
- Being tested
- peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block
- Keywords
- femoral nerve block, peri-neural dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve blockDrug
ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.
After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group B: control bupivacaine group | Placebo comparator | Patient in this group will receive 25 ml bupivacaine 0.5% plus 0.5 ml normal saline peri-neurally and 0.5 ml subcutaneous normal saline. Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block |
| Group B-peri-DEX: Peri-neural Dexmedetomidine | Experimental | Patients in this group will receive 25 ml of 0.5% bupivacaine plus 0.5 ml (50 microgram) Dexmedetomidine peri-neurally and 0.5 ml subcutaneous normal saline Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block |
| Group B-sys-DEX:Systemic Dexmedetomidine | Active comparator | Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine. Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study will be the change of sensory block over time.
Over a period of 30 min after injection of the study medications, a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation (10). Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve
Measured: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours
Secondary outcomes (1)
onset of motor and sensory block
The onset time of sensory and motor block will be: "the time elapsed between the end of injection and the development of complete block (score of 0 at all dermatomes or no movement of the quadriceps muscle.
Measured: up to 30 minutes after the end of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onset and Duration of Sensory and Motor Block of Femoral Nerve,Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- anesthesia department, faculty of medicine
- Responsible party
- Principal investigator, Abeer Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964040
- Sponsor's protocol ID
- N-38-2013
- Status last verified
- Oct 2013
- First submitted
- 26 Sep 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
- ClinicalTrials.gov ID
- NCT01964040
- Acronym / sponsor ID
- N-38-2013
- Conditions
- Onset and Duration of Sensory and Motor Block of Femoral Nerve,, Visual Analogue Pain Scores,, Time to First Request of Rescue Analgesics,, Total Morphine Consumption in 24 Hours
- Keywords
- femoral nerve block, peri-neural dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- anesthesia department, faculty of medicine
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 17 Oct 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 duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group B: control bupivacaine group | Placebo comparator | Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve blockPatient in this group will receive 25 ml bupivacaine 0.5% plus 0.5 ml normal saline peri-neurally and 0.5 ml subcutaneous normal saline. |
| Group B-peri-DEX: Peri-neural Dexmedetomidine | Experimental | Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve blockPatients in this group will receive 25 ml of 0.5% bupivacaine plus 0.5 ml (50 microgram) Dexmedetomidine peri-neurally and 0.5 ml subcutaneous normal saline |
| Group B-sys-DEX:Systemic Dexmedetomidine | Active comparator | Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve blockPatients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients with ASA physical status I or II, scheduled for diagnostic knee arthroscopy
Key exclusion criteria (1 listed)
- Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
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 |
|---|---|---|
| peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve blockultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously. After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia | Drug | Group B-peri-DEX: Peri-neural Dexmedetomidine, Group B-sys-DEX:Systemic Dexmedetomidine, group B: control bupivacaine group |
Primary outcome
The primary outcome measure of this study will be the change of sensory block over time.
Time frame: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours
Over a period of 30 min after injection of the study medications, a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation (10). Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve
1 secondary outcome
onset of motor and sensory block
Time frame: up to 30 minutes after the end of injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block in people with Onset and Duration of Sensory and Motor Block of Femoral Nerve, and Visual Analogue Pain Scores,, run by Cairo University at 1 site in Egypt.
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 1 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 17 Oct 2013. 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 Egypt. 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?
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?
The primary outcome measure of this study will be the change of sensory block over time. (time frame: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours). 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 17 Oct 2013.