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

NCT ID: NCT03118076

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2017-07-31

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.

Conditions

Free Flap Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group R

Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine.

Group Type: PLACEBO_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Nerve blocks were administered with 0.3% ropivacaine.

Group RD

Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.

Group Type: EXPERIMENTAL

0.3% ropivacaine and 50 μg dexmedetomidine

Intervention Type: DRUG

Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.

Interventions

0.3% ropivacaine and 50 μg dexmedetomidine

Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.

Intervention Type: DRUG

Ropivacaine

Nerve blocks were administered with 0.3% ropivacaine.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaofeng Bai

OTHER

Sponsor Role: lead

Responsible Party

Xiaofeng Bai

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, China

Countries

China

Central Contacts

xiaofeng Bai

Role: CONTACT

xiaofengbai@sina.cn

8624 31927811

Facility Contacts

Xiaofeng Bai

Role: primary

Other Identifiers

Dexmedetomidine in nerve block

Identifier Type: -

Identifier Source: org_study_id