Postoperative PainPCOGSNCT01418183
Pain Control After Orthognathic Surgery
A study testing Trigeminal nerve block in people with Postoperative Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Trigeminal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in Chang Gung Memorial Hospital since July 2011
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei, 10507
Yi-Chieh Chen, MD, Pschenyc@yahoo.com.tw
Yi-Chieh Chen, MD
About this study
Official title: 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.
Read the 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:
- whether the pain relieve effect is dose-related
- 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
- Being tested
- Trigeminal nerve block
- Keywords
- Orthognathic surgery, Pain control, Trigeminal nerve, Levobupivacaine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal nerve blockProcedure or surgery
Also called 5ml Chirocaine
5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Trigeminal nerve blockProcedure or surgery
Also called 2.5ml Chirocaine
2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
Trigeminal nerve blockProcedure or surgery
Also called Placebo
5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
| Study group | Role | What they receive |
|---|---|---|
| 5ml 5% levobupivacaine | Experimental | 5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) Receives: Procedure: Trigeminal nerve block |
| 5ml normal saline | Placebo comparator | 5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side) Receives: 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) Receives: Procedure: Trigeminal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The degree of pain will be measured daily by visual analog scale.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3days
Secondary outcomes (1)
Effective duration of levobupivacaine nerve block
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chieh Chen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418183
- Sponsor's protocol ID
- 100-0548A3
- Acronym
- PCOGS
- Status last verified
- Jun 2011
- First submitted
- 12 Aug 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Trigeminal Nerve Block For Post-operative Pain Control After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT01418183
- Acronym / sponsor ID
- PCOGS / 100-0548A3
- Conditions
- Postoperative Pain
- Keywords
- Orthognathic surgery, Pain control, Trigeminal nerve, Levobupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- whether the pain relieve effect is dose-related
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5ml 5% levobupivacaine | Experimental | Procedure: Trigeminal nerve block5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) |
| 5ml normal saline | Placebo comparator | Procedure: Trigeminal nerve block5ml for maxillary and mandibular branches of trigeminal nerve (total 10ml on controlled side) |
| 2.5ml 5% levobupivacaine | Experimental | Procedure: Trigeminal nerve block2.5ml 5% levobupivacaine to both maxillary and mandibular branches of trigeminal nerve on experimental side. (total 10ml) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in Chang Gung Memorial Hospital since July 2011
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigeminal nerve blockAlso: 5ml Chirocaine5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve. | Procedure or surgery | 5ml 5% levobupivacaine |
| Trigeminal nerve blockAlso: 2.5ml Chirocaine2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve. | Procedure or surgery | 2.5ml 5% levobupivacaine |
| Trigeminal nerve blockAlso: Placebo5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve. | Procedure or surgery | 5ml normal saline |
Primary outcome
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.
1 secondary outcome
Effective duration of levobupivacaine nerve block
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chieh Chen, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigeminal nerve block in people with Postoperative Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chieh Chen, MD (+886-975-365553, Pschenyc@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: participants will be followed for the duration of hospital stay, an expected average of 3days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011; AzTrials last refreshed its copy on 28 Oct 2026.