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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Free Flap Reconstruction
• Intervention / Treatment: Drug: Ropivacaine; Drug: 0.3% ropivacaine and 50 μg dexmedetomidine

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
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • School & Hospital of Stomatology, China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The duration of sensory blocks was recorded up to 48 hours after injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation level	Sedation level was assessed using visual scale.	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.	every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours

Collaborators and Investigators

• Sponsor: Xiaofeng Bai

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 20, 2017
• Primary Completion (ANTICIPATED): July 31, 2017
• Study Completion (ANTICIPATED): July 31, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: Dexmedetomidine in nerve block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No