Pain Control After Orthognathic Surgery (PCOGS)

September 4, 2011 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.)

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10507
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yi-Chieh Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 5ml Chirocaine
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 Names:
  • 2.5ml Chirocaine
Procedure: Trigeminal nerve block
5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Names:
  • Placebo
Placebo Comparator: 5ml normal saline
5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side)
Procedure: Trigeminal nerve block
5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Names:
  • 5ml Chirocaine
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 Names:
  • 2.5ml Chirocaine
Procedure: Trigeminal nerve block
5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Names:
  • 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
5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Names:
  • 5ml Chirocaine
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 Names:
  • 2.5ml Chirocaine
Procedure: Trigeminal nerve block
5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3days
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
Time Frame
Effective duration of levobupivacaine nerve block
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
participants will be followed for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yi-Chieh Chen, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 12, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 4, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-0548A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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