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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

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date April 18, 2017
Estimated Study Start Date  ICMJE April 20, 2017
Estimated Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks
Official Title  ICMJE The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks Following Oromaxillofacial Reconstruction
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Free Flap Reconstruction
Intervention  ICMJE
  • Drug: 0.3% ropivacaine and 50 μg dexmedetomidine
    Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
  • Drug: Ropivacaine
    Nerve blocks were administered with 0.3% ropivacaine.
Study Arms  ICMJE
  • Placebo Comparator: Group R
    Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine.
    Intervention: Drug: Ropivacaine
  • Experimental: Group RD
    Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
    Intervention: Drug: 0.3% ropivacaine and 50 μg dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2017
Estimated Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118076
Other Study ID Numbers  ICMJE Dexmedetomidine in nerve block
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiaofeng Bai, China Medical University, China
Study Sponsor  ICMJE Xiaofeng Bai
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Medical University, China
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP