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

Free Flap Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03118076
• Other study ID #: Dexmedetomidine in nerve block
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 16, 2017
• Last updated: April 14, 2017
• Start date: April 20, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: April 2017
• Source: China Medical University, China
• Contact: xiaofeng Bai
• Phone: 8624 31927811
• Email: xiaofengbai[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Free Flap Reconstruction

Intervention

Drug:
• 0.3% ropivacaine and 50 µg dexmedetomidine
Nerve blocks were administered with 0.3% ropivacaine and 50 µg dexmedetomidine.
• Ropivacaine
Nerve blocks were administered with 0.3% ropivacaine.

Locations

Country	Name	City	State
China	School & Hospital of Stomatology, China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xiaofeng Bai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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