DexmedetomidinePhase 4NCT02089932
Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
A Phase 4 study testing peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block in people with Dexmedetomidine and Femoral Nerve Block, 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 15 to 45 years
- Conditions the study is for
- Dexmedetomidine, Femoral Nerve Block, Arthroscopic Knee Surgery
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2014to Jun 2015
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery
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.
About this study
Official title: The Effects of Different Dose Levels of Peri-neural Dexmedetomidine on the Pharmacodynamic and Side Effects Profiles of 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 in different dose levels as adjuvant to local anesthetic was not previously reported for femoral nerve block.
- Being tested
- peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block, Placebo
- 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 guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.
After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia.
PlaceboDrug
| 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 1 ml normal saline peri-neurally Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block; Drug: Placebo |
| Group B-DEX 25 : Peri-neural Dexmedetomidine | Experimental | Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (25 microgram) Dexmedetomidine peri-neurally Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block |
| Group B-DEX 50:Peri-neural Dexmedetomidine | Experimental | Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (50 microgram) Dexmedetomidine peri-neurally Receives: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block |
| Group B-DEX 75:Peri-neural Dexmedetomidine | Experimental | Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (75microgram) Dexmedetomidine peri-neurally 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.
duration of sensory block
the time interval between the onset of the sensory block and the complete resolution of normal sensation. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of normal sensation; 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. Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve.
Measured: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.
Secondary outcomes (9)
Time to first request of postoperative rescue analgesic
the time interval between the onset of successful sensory block and the first request to postoperative analgesia
Measured: over the first postoperative 24hours
Onset of sensory block
the time elapsed between the end of injection and the development of complete sensory block
Measured: up to 30 minutes after the end of injection
Onset of motor block
the time elapsed between the end of injection and the development of complete motor block
Measured: up to 30 minutes after the end of injection
visual analogue pain scores (VAS)
Visual analogue pain scores (resting and dynamic VAS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.
Measured: 2hours post operative and for 24hours
Richmond Agitation-Sedation Score (RASS)
Richmond Agitation-Sedation Score (RASS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.
Measured: 2hours post operative and for 24hours
duration of motor block
The time interval between the onset of the motor block and the complete resolution of the motor power in quadriceps muscle. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of motor power; a blinded investigator will assess the motor block using a 3-point scale where: 0 ═ no movement, 1 ═ reduced motor strength, but some perceptible movement, and 2 ═ normal motor function.
Measured: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of motor power.
total morphine consumption
The total dose of morphine needed by the patient postoperatively till 24 hours.
Measured: The first 24 hours postoperatively
perioperative hemodynamic parameters
Vital signs (heart rate and arterial blood pressure) will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.
Measured: will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.
incidence of side effects.
Adverse events will be defined as hypotension (a 30% decrease in systolic blood pressure in relation to the baseline value), bradycardia (heart rate less than 60 beats per minute), desaturation (SpO2 < 90% on room air) and postoperative nausea and/or vomiting.
Measured: from the injection time till 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Nassar,MD, Cairo University
- Investigators
- Mohamed Abdulatif, Professor of Anesthesia, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089932
- Sponsor's protocol ID
- N-60-2013
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Dose Levels of Peri-neural Dexmedetomidine on the Pharmacodynamic and Side Effects Profiles of Bupivacaine-induced Ultrasound-guided Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT02089932
- Acronym / sponsor ID
- N-60-2013
- Keywords
- femoral nerve block, peri-neural dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Mar 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.
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 in different dose levels 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
- 4
| Arm | Type | Receives |
|---|---|---|
| group B: control bupivacaine group | Placebo comparator | Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block, Drug: PlaceboPatient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally |
| Group B-DEX 25 : 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 1 ml (25 microgram) Dexmedetomidine peri-neurally |
| Group B-DEX 50: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 1 ml (50 microgram) Dexmedetomidine peri-neurally |
| Group B-DEX 75: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 1 ml (75microgram) Dexmedetomidine peri-neurally |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery
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 guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally. After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia. | Drug | Group B-DEX 25 : Peri-neural Dexmedetomidine, Group B-DEX 50:Peri-neural Dexmedetomidine, Group B-DEX 75:Peri-neural Dexmedetomidine, group B: control bupivacaine group |
| Placebo | Drug | group B: control bupivacaine group |
Primary outcome
duration of sensory block
Time frame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.
the time interval between the onset of the sensory block and the complete resolution of normal sensation. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of normal sensation; 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. Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve.
9 secondary outcomes
Time to first request of postoperative rescue analgesic
Time frame: over the first postoperative 24hours
Onset of sensory block
Time frame: up to 30 minutes after the end of injection
Onset of motor block
Time frame: up to 30 minutes after the end of injection
visual analogue pain scores (VAS)
Time frame: 2hours post operative and for 24hours
Richmond Agitation-Sedation Score (RASS)
Time frame: 2hours post operative and for 24hours
duration of motor block
Time frame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of motor power.
total morphine consumption
Time frame: The first 24 hours postoperatively
perioperative hemodynamic parameters
Time frame: will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.
incidence of side effects.
Time frame: from the injection time till 24 hours postoperatively
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 15 Jan 2019.
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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.
Mohamed Abdulatif, Professor of Anesthesia study chair
Cairo University
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 Dexmedetomidine and Femoral Nerve Block, 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: finished, as of the sponsor's last update on 15 Jan 2019. 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?
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?
duration of sensory block (time frame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.). 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 15 Jan 2019.