Free Flap Reconstruction Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | School & Hospital of Stomatology, China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Xiaofeng Bai |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04069650 -
Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
|