Free Flap ReconstructionPhase 4NCT03118076
The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks
A Phase 4 study testing 0.3% ropivacaine and 50 μg dexmedetomidine and Ropivacaine in people with Free Flap Reconstruction, run by Xiaofeng Bai at 1 site in China.
Trial summary
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Flap Reconstruction
- What is being tested?
- 0.3% ropivacaine and 50 μg dexmedetomidine and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to 31 Jul 2017
- 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
- Diagnosis of oral and maxillofacial tumor.
- Undergoing microsurgical oromandibular reconstruction with free fibular flaps or anterolateral thigh flaps.
- Greater than 18 years old.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- True allergy to local anesthetics or dexmedetomidine.
- History of chronic pain on opioids within the last 12 months.
- Specific mental health issues such as schizophrenia or bipolar disorder.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site
School & Hospital of Stomatology, China Medical University
Shenyang, Liaoning, 110002
Xiaofeng Bai
About this study
Official title: The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks Following Oromaxillofacial Reconstruction
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
Read more
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. In Group Ropivacaine (Group R), nerve blocks were administered with 0.3% ropivacaine. In Group Ropivacaine + Dexmedetomidine (Group RD), nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, SpO2, sedation level, the duration of motor blocks.
Read the detailed description
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. For patients with free fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with anterolateral thigh flaps harvested, femoral nerve block with ropivacaine was administered.In Group R, nerve blocks were administered with 0.3% ropivacaine. In Group RD, nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, pulse oxygen saturation (SpO2), sedation level, the duration of motor blocks.
- Conditions
- Free Flap Reconstruction
- Being tested
- 0.3% ropivacaine and 50 μg dexmedetomidine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% ropivacaine and 50 μg dexmedetomidineDrug
Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
RopivacaineDrug
Nerve blocks were administered with 0.3% ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group R | Placebo comparator | Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine. Receives: Drug: Ropivacaine |
| Group RD | Experimental | Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine. Receives: Drug: 0.3% ropivacaine and 50 μg dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of sensory blocks
The duration of sensory block was defined as the time interval between the end of ropivacaine administration and the pain score up to 5.
Measured: The duration of sensory blocks was recorded up to 48 hours after injection.
Secondary outcomes (2)
sedation level
Sedation level was assessed using visual scale.
Measured: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours
heart rate
If the heart rate is lower 50 beat/minute, atropine was administered.
Measured: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start20 Apr 2017 (estimated)
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Flap ReconstructionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaofeng Bai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaofeng Bai, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118076
- Sponsor's protocol ID
- Dexmedetomidine in nerve block
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks Following Oromaxillofacial Reconstruction
- ClinicalTrials.gov ID
- NCT03118076
- Acronym / sponsor ID
- Dexmedetomidine in nerve block
- Conditions
- Free Flap Reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiaofeng BaiUniversity, hospital or other
- Study start
- 20 Apr 2017 (estimated)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Jul 2017 (estimated)
- First posted
- 18 Apr 2017 (actual)
- 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.
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. In Group Ropivacaine (Group R), nerve blocks were administered with 0.3% ropivacaine. In Group Ropivacaine + Dexmedetomidine (Group RD), nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, SpO2, sedation level, the duration of motor blocks.
Detailed description
Peripheral nerve block has been recommended as the technique for postoperative pain management because it provides equivalent analgesia but with fewer adverse effects than either systemic or epidural analgesia.
The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve blocks has not been described.
In this study, we investigated the effect of adding dexmedetomidine as additive in femoral and common peroneal nerve blocks for postoperative analgesia.
Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or anterolateral thigh flap reconstruction, were divided into two groups in a randomized, double-blind fashion. For patients with free fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with anterolateral thigh flaps harvested, femoral nerve block with ropivacaine was administered.In Group R, nerve blocks were administered with 0.3% ropivacaine. In Group RD, nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood pressure, pulse oxygen saturation (SpO2), sedation level, the duration of motor blocks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R | Placebo comparator | Drug: RopivacaineNerve blocks were administered with 0.3% ropivacaine without dexmedetomidine. |
| Group RD | Experimental | Drug: 0.3% ropivacaine and 50 μg dexmedetomidineNerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of oral and maxillofacial tumor.
- Undergoing microsurgical oromandibular reconstruction with free fibular flaps or anterolateral thigh flaps.
- Greater than 18 years old.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- True allergy to local anesthetics or dexmedetomidine.
- History of chronic pain on opioids within the last 12 months.
- Specific mental health issues such as schizophrenia or bipolar disorder.
- Patients who are pregnant.
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 |
|---|---|---|
| 0.3% ropivacaine and 50 μg dexmedetomidineNerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine. | Drug | Group RD |
| RopivacaineNerve blocks were administered with 0.3% ropivacaine. | Drug | Group R |
Primary outcome
the duration of sensory blocks
Time frame: The duration of sensory blocks was recorded up to 48 hours after injection.
The duration of sensory block was defined as the time interval between the end of ropivacaine administration and the pain score up to 5.
2 secondary outcomes
sedation level
Time frame: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours
heart rate
Time frame: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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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.
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 0.3% ropivacaine and 50 μg dexmedetomidine and Ropivacaine in people with Free Flap Reconstruction, run by Xiaofeng Bai at 1 site in China.
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 4 inclusion and 4 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 18 Apr 2017. 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 China. 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?
Contact xiaofeng Bai (8624 31927811, xiaofengbai@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of sensory blocks (time frame: The duration of sensory blocks was recorded up to 48 hours after injection.). 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 18 Apr 2017.