Pain Control After Orthognathic Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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:

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.) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01418183
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Yi-Chieh Chen, MD
Phone	+886-975-365553
Email	Pschenyc@yahoo.com.tw
Status	Recruiting
Phase	N/A
Start date	July 2011
Completion date	December 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pain Control After Orthognathic Surgery — PCOGS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms