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This study will assess the efficacy and safety of levobupivacaine for postoperative pain control in patients received orthognathic surgery. In this split-mouth study, each side will be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3) placebo. One shot of these agents will be delivered by nerve block to maxillary and mandibular branches of trigeminal nerve before the incision was made. The degree of postoperative pain will be evaluated daily by visual analog scale for up to 3 days. The anticipated time on study is 1 year, and the target sample size is 40 individuals.
Design of intervention vs. control Intra-operative injective of (chirocaine) before incision Location of injection: inferior alveolar nerve proximal to its entrance to ramus of mandible, maxillary nerve around pterygopalatine ganglion Amount of injection on each injection site: (1) Experimental group 1: 5mg/ml chirocaine 5cc (2)Experimental group 2: 5mg/ml chirocaine 2.5cc (3)Control group: normal saline 5cc. There are totally 4 injection sites for two jaw surgery and 2 injection sites for one jaw surgery. The experimental site and control site will be determined randomly before injection.
Outcome measurement
Primary: effectiveness of intra-operative nerve block on post-operative pain control
Secondary:
The intensity of post-operative pain will be measured by VAS, visual analog scale)daily until patients are discharged.
Report adverse outcome:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5ml 5% levobupivacaine | Experimental | 5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) |
|
| 5ml normal saline | Placebo Comparator | 5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side) |
|
| 2.5ml 5% levobupivacaine | Experimental | 2.5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigeminal nerve block | Procedure | 5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | The degree of pain will be measured daily by visual analog scale. | participants will be followed for the duration of hospital stay, an expected average of 3days |
| Measure | Description | Time Frame |
|---|---|---|
| Effective duration of levobupivacaine nerve block | participants will be followed for the duration of hospital stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Chieh Chen, MD | Contact | +886-975-365553 | Pschenyc@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Chieh Chen, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taipei | 10507 | Taiwan |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Trigeminal nerve block | Procedure | 2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve. |
|
|
| Trigeminal nerve block | Procedure | 5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |