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The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks

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ClinicalTrials.gov Identifier: NCT03118076
Recruitment Status : Unknown
Verified April 2017 by Xiaofeng Bai, China Medical University, China.
Recruitment status was:  Not yet recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaofeng Bai, China Medical University, China

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Free Flap Reconstruction Drug: 0.3% ropivacaine and 50 μg dexmedetomidine Drug: Ropivacaine Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks Following Oromaxillofacial Reconstruction
Estimated Study Start Date : April 20, 2017
Estimated Primary Completion Date : July 31, 2017
Estimated Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group R
Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine.
 Drug: Ropivacaine
Nerve blocks were administered with 0.3% ropivacaine.
Experimental: Group RD
Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
 Drug: 0.3% ropivacaine and 50 μg dexmedetomidine
Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. sedation level [ Time Frame: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours ]
    Sedation level was assessed using visual scale.

  2. heart rate [ Time Frame: every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours ]
    If the heart rate is lower 50 beat/minute, atropine was administered.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118076


Contacts
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Contact: xiaofeng Bai 8624 31927811 xiaofengbai@sina.cn

Locations
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China, Liaoning
School & Hospital of Stomatology, China Medical University
Shenyang, Liaoning, China, 110002
Contact: Xiaofeng Bai         
Sponsors and Collaborators
Xiaofeng Bai
More Information
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Responsible Party: Xiaofeng Bai, Associate Professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT03118076    
Other Study ID Numbers: Dexmedetomidine in nerve block
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics