Pain Control After Orthognathic Surgery

NCT ID: NCT01418183

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-12-31

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:

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

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5ml 5% levobupivacaine

5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml)

Group Type: EXPERIMENTAL

Trigeminal nerve block

Intervention Type: PROCEDURE

5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.

5ml normal saline

5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side)

Group Type: PLACEBO_COMPARATOR

Trigeminal nerve block

Intervention Type: PROCEDURE

5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.

2.5ml 5% levobupivacaine

2.5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml)

Group Type: EXPERIMENTAL

Trigeminal nerve block

Intervention Type: PROCEDURE

2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.

Interventions

Trigeminal nerve block

5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.

Intervention Type: PROCEDURE

Trigeminal nerve block

2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.

Intervention Type: PROCEDURE

Trigeminal nerve block

5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.

Intervention Type: PROCEDURE

Other Intervention Names

5ml Chirocaine; 2.5ml Chirocaine; Placebo

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Chieh Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Chieh Chen, MD

Role: CONTACT

Pschenyc@yahoo.com.tw

+886-975-365553

Facility Contacts

Yi-Chieh Chen, MD

Role: primary

Pschenyc@yahoo.com.tw

Other Identifiers

100-0548A3

Identifier Type: -

Identifier Source: org_study_id