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

NCT03118076 | Unknown Phase 4

• 1 other identifier: Dexmedetomidine in nerve block
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Free Flap Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• sedation level

  every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours

• heart rate

  every 5 minutes until 30 minutes after injection, and then every 60 minutes up to 48 hours

Study Arms (2)

Group R

PLACEBO COMPARATOR

Nerve blocks were administered with 0.3% ropivacaine without dexmedetomidine.

Drug: Ropivacaine

Group RD

EXPERIMENTAL

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

Drug: 0.3% ropivacaine and 50 μg dexmedetomidine

Interventions

0.3% ropivacaine and 50 μg dexmedetomidine DRUG

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

Group RD

Ropivacaine DRUG

Nerve blocks were administered with 0.3% ropivacaine.

Group R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaofeng Bai: lead

Study Sites (1)

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, 110002, China

Location

MeSH Terms

Interventions

Ropivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

xiaofeng Bai

CONTACT

8624 31927811; xiaofengbai@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 18, 2017
• Study Start: April 20, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)