NCT01418183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 7, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

August 12, 2011

Last Update Submit

September 4, 2011

Conditions

Postoperative Pain

Keywords

Orthognathic surgeryPain controlTrigeminal nerveLevobupivacaine

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    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 Outcomes (1)

  • Effective duration of levobupivacaine nerve block

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (3)

5ml 5% levobupivacaine

EXPERIMENTAL

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

Procedure: Trigeminal nerve block

5ml normal saline

PLACEBO COMPARATOR

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

Procedure: Trigeminal nerve block

2.5ml 5% levobupivacaine

EXPERIMENTAL

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

Procedure: Trigeminal nerve block

Interventions

Trigeminal nerve blockPROCEDURE

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

Also known as: 5ml Chirocaine
5ml 5% levobupivacaine

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in Chang Gung Memorial Hospital since July 2011

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yi-Chieh Chen, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chieh Chen, MD

CONTACT

+886-975-365553Pschenyc@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 17, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

September 7, 2011

Record last verified: 2011-06

Locations

TW(1)