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Pain Control After Orthognathic Surgery (PCOGS)

This study is currently recruiting participants.
Verified June 2011 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01418183
First received: August 12, 2011
Last updated: September 4, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Procedure: Trigeminal nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-operative Trigeminal Nerve Block For Post-operative Pain Control After Orthognathic Surgery

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3days ] [ Designated as safety issue: No ]
    The degree of pain will be measured daily by visual analog scale.


Secondary Outcome Measures:
  • Effective duration of levobupivacaine nerve block [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5ml 5% levobupivacaine
5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml)
 Procedure: Trigeminal nerve block
5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Name: 5ml Chirocaine
Placebo Comparator: 5ml normal saline
5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side)
 Procedure: Trigeminal nerve block
5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Name: Placebo
Experimental: 2.5ml 5% levobupivacaine
2.5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml)
 Procedure: Trigeminal nerve block
2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Name: 2.5ml Chirocaine

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.)
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418183

Contacts
Contact: Yi-Chieh Chen, MD +886-975-365553 Pschenyc@yahoo.com.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 10507
Contact: Yi-Chieh Chen, MD         Pschenyc@yahoo.com.tw    
Principal Investigator: Yi-Chieh Chen, MD            
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yi-Chieh Chen, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01418183     History of Changes
Other Study ID Numbers: 100-0548A3
Study First Received: August 12, 2011
Last Updated: September 4, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Orthognathic surgery
Pain control
Trigeminal nerve
Levobupivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Levobupivacaine
Bupivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013