Pain Control After Orthognathic Surgery

Overview

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: 1. whether the pain relieve effect is dose-related 2. 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.)

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

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