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The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the oromandibular defects is well established, whereas few attentions were focused on postoperative analgesia for the donor area. Dexmedetomidine is a more selective and shorter-acting α2 adrenergic receptor. The purpose of this trial is to determine if using lower limb nerve blocks in patients undergoing free flap-based oromandibular reconstruction can significantly decrease use of pain medications and to evaluate the safety of lower limb nerve blocks. We also investigated the effect of adding dexmedetomidine as additive in femoral nerve blocks for postoperative analgesia.
Patients with oromandibular defects who were scheduled for elective reconstructive surgery using free fibular or ALT flaps, were divided into three groups in a randomized, single-blind fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used. In Group PCA+B+D, both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used. Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage, vital signs, onset and duration of sensory and motor block, the presence of adverse effects such as nausea and vomiting were recorded.
The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the oromandibular defects is well established, whereas few attentions were focused on postoperative analgesia for the donor area. Conventional postoperative pain management following oromandibular reconstruction consists of systemic opioids, which can cause nausea, vomiting, pruritus, urinary retention, constipation and respiratory depression. Adequate postoperative analgesia decreases the incidence of cardiopulmonary complications. Peripheral nerve blocks can attenuate the sensory innervations.The purpose of this trial is to determine if using lower limb nerve blocks in patients undergoing free flap-based oromandibular reconstruction can significantly decrease use of pain medications and to evaluate the safety of lower limb nerve blocks.
Patients with oromandibular defects, who were scheduled for elective reconstructive surgery using free fibular or ALT flaps, were divided into three groups in a randomized, single-blind fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used.In Group PCA+B+D, both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used. For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered. Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage, vital signs, onset and duration of sensory and motor block, the presence of adverse effects such as nausea and vomiting were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group PCA+B | Experimental | Both intravenous PCA and lower limb blocks were used. For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve block with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered.The interventions are femoral nerve block, common peroneal nerve block. |
|
| Group PCA | No Intervention | Only intravenous patient controlled analgesia (PCA) was used postoperatively. | |
| Group PCA+B+D | Experimental | Both intravenous PCA and lower limb blocks with dexmedetomidine as additivewere used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| femoral nerve block, common peroneal nerve block | Procedure | For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Narcotic Usage | Total intravenous sulfentanyl usage for rescue analgesia in first 48 hours post-operatively after free fibular flaps and anterolateral thigh flap reconstruction. | 48 hours |
| duration of sensory blockade | the time of sensory recovery | 48 hours |
| duration of motor blockade | the time of motor recovery | 48 hours |
| onset of sensory blockade | the time to sensory blockade | 48 hours |
| onset of motor blockade | the time to motor blockade | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Anti-emetic Usage | Post-operative Anti-emetic Usage is defined as the total amount of IV tropisetron administered to a patient during the first 48 hours post-operatively. | 48 hours |
| vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xia zhang, Ph.D.,MD | Contact | 8624 31927811 | zhangxiamd@126.com |
| Name | Affiliation | Role |
|---|---|---|
| xia zhang, Ph.D,MD | School & Hospital of Stomatology, China Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School & Hospital of Stomatology, China Medical University | Recruiting | Shenyang | Liaoning | 110002 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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hear rate, blood pressure, SPO2
| 48 hours |
| Post-operative Pain Score | Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient reported pain score on a scale of 0-10. | 48 hours |
| adverse effects | such as bradycardia, hypotension,respiratory depression, postoperative sedation | 48 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |