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

• ClinicalTrials.gov Identifier: NCT03118076
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: April 18, 2017
• Sponsor: Xiaofeng Bai
• Information provided by (Responsible Party): Xiaofeng Bai, China Medical University, China

Tracking Information

• First Submitted Date: March 16, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: April 18, 2017
• Estimated Study Start Date: April 20, 2017
• Estimated Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Dexmedetomidine as an Adjuvant for Lower Limb Nerve Blocks
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Free Flap Reconstruction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 14, 2017): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2017
• Estimated Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03118076
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Xiaofeng Bai, China Medical University, China
• Study Sponsor: Xiaofeng Bai
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: China Medical University, China
• Verification Date: April 2017