Pain Control After Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: whether the pain relieve effect is dose-related how long will this effect last The intensity of post-operative pain will be measured by VAS, visual analog scale)daily until patients are discharged. Report adverse outcome: Intolerable pain on control group Adverse reaction to local anesthetic agent Injection-related complications (puncture of major vessels, hematoma on -injection site, etc.)

Official Title
-----------------
Intra-operative Trigeminal Nerve Block For Post-operative Pain Control After Orthognathic Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Trigeminal nerve block
* Procedure: Trigeminal nerve block
* Procedure: Trigeminal nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in Chang Gung Memorial Hospital since July 2011 Exclusion Criteria: more complex (2- or more piece LeFort I osteotomy, combined gonial resection in BSSO, etc.) or less complex (only Wassmund and/or Kole osteotomies in upper or lower jaw) orthognathic procedures unexpected fracture (unilateral) intra-operative nerve injuries significant facial asymmetry which demands different procedures (location of osteotomy, extension of muscle stripping, etc.) cleft patient, post-traumatic patients, patients with craniofacial syndromes or other neurological or systemic problems which might interfere pain evaluation post-operatively

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5ml 5% levobupivacaine<br>5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) | Procedure: Trigeminal nerve block<br>* 5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.<br>* Other names: 5ml Chirocaine;|
| Placebo Comparator: 5ml normal saline<br>5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side) | Procedure: Trigeminal nerve block<br>* 5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.<br>* Other names: Placebo;|
| Experimental: 2.5ml 5% levobupivacaine<br>2.5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) | Procedure: Trigeminal nerve block<br>* 2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.<br>* Other names: 2.5ml Chirocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthognathic surgery, Pain control, Trigeminal nerve, Levobupivacaine