Postoperative PainNCT07518225
Pre-Extubation Bupivacaine for Pain Control After Orthognathic Surgery
A study testing Bupivacaine Infiltration and Standard medical treatment in people with Postoperative Pain and Orthognathic Surgery, run by Esra Beyler at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate whether injecting a long-acting local anesthetic (bupivacaine) at surgical sites before awakening from anesthesia can reduce pain and the need for opioid medications after orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Orthognathic Surgery
- What is being tested?
- Bupivacaine Infiltration and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2022to 2 Sep 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II, age between 18 and 65 years, and planned one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy
Who cannot join
- refusal to participate, ASA score ≥ III, congenital craniofacial anomalies, previous maxillofacial surgery, history of chronic opioid use, and allergy to local anesthetics or opioids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-extubation Bupivacaine Infiltration on Postoperative Pain and Opioid Consumption After Orthognathic Surgery
This study aims to evaluate whether injecting a long-acting local anesthetic (bupivacaine) at surgical sites before awakening from anesthesia can reduce pain and the need for opioid medications after orthognathic surgery. Orthognathic surgery is a major procedure that can cause significant postoperative pain, often requiring opioid analgesics, which may lead to side effects such as nausea, vomiting, and drowsiness. In this randomized clinical study, patients undergoing jaw surgery received either standard care or additional bupivacaine infiltration before extubation. Pain levels and opioid consumption were measured during the first 48 hours after surgery. We hypothesized that pre-extubation bupivacaine infiltration would improve pain control and reduce opioid requirements.
Read the detailed description
Orthognathic surgery is commonly associated with moderate to severe postoperative pain, often requiring opioid-based analgesia. However, opioid use may be associated with adverse effects such as nausea, vomiting, sedation, and respiratory depression. Therefore, optimizing postoperative pain management while minimizing opioid consumption remains an important clinical goal.Local anesthetic infiltration has been proposed as a simple and effective method for improving postoperative analgesia. Bupivacaine, a long-acting local anesthetic, may provide prolonged pain control when administered at surgical sites.This randomized clinical study was conducted to evaluate the effect of pre-extubation infiltration of bupivacaine on postoperative pain and opioid consumption in patients undergoing orthognathic surgery. Patients undergoing one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy were randomly assigned to either a control group receiving standard care or a study group receiving additional infiltration of 0.5% bupivacaine with epinephrine at surgical sites prior to extubation.Postoperative pain was assessed using a visual analogue scale at predefined time points over a 48-hour period. Morphine consumption, including total and rescue doses, was recorded during the first 24 hours.It was hypothesized that pre-extubation bupivacaine infiltration would reduce postoperative pain intensity and opioid requirements compared with standard care
- Conditions
- Postoperative Pain, Orthognathic Surgery
- Being tested
- Bupivacaine Infiltration, Standard medical treatment
- Keywords
- Orthognathic Surgery, Bupivacaine, Opioid, Pain management, Postoperative pain
- 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.
Bupivacaine InfiltrationDrug
Pre-extubation local infiltration of 0.5% bupivacaine with epinephrine was administered at the surgical sites in addition to standard perioperative care
Standard medical treatmentDrug
Patients received standard perioperative care without pre-extubation bupivacaine infiltration
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Experimental | Patients received standard perioperative care along with pre-extubation infiltration of 0.5% bupivacaine with epinephrine at the surgical sites Receives: Drug: Bupivacaine Infiltration |
| Control group | Active comparator | Patients received standard perioperative care without pre-extubation bupivacaine infiltration. Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst possible pain, with higher scores indicating greater pain intensity, measured at 3, 6, 9, 12, 18, 24, 30, and 48 hours postoperatively.
Measured: Up to 48 hours after surgery
Morphine Consumption
Within the first 24 hours after surgery
Measured: Total and rescue morphine consumption recorded during the first 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start2 Sep 2022
- Primary completion1 Sep 2025
- Study completion2 Sep 2025
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
- Model description
- two group; study vs control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esra Beyler
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, Esra Beyler, Baskent University
- Investigators
- Esra Beyler, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518225
- Sponsor's protocol ID
- D-KA26/14
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-extubation Bupivacaine Infiltration on Postoperative Pain and Opioid Consumption After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07518225
- Acronym / sponsor ID
- D-KA26/14
- Conditions
- Postoperative Pain, Orthognathic Surgery
- Keywords
- Orthognathic Surgery, Bupivacaine, Opioid, Pain management, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Esra BeylerUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 8 Apr 2026 (actual)
- 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 aims to evaluate whether injecting a long-acting local anesthetic (bupivacaine) at surgical sites before awakening from anesthesia can reduce pain and the need for opioid medications after orthognathic surgery. Orthognathic surgery is a major procedure that can cause significant postoperative pain, often requiring opioid analgesics, which may lead to side effects such as nausea, vomiting, and drowsiness. In this randomized clinical study, patients undergoing jaw surgery received either standard care or additional bupivacaine infiltration before extubation. Pain levels and opioid consumption were measured during the first 48 hours after surgery. We hypothesized that pre-extubation bupivacaine infiltration would improve pain control and reduce opioid requirements.
Detailed description
Orthognathic surgery is commonly associated with moderate to severe postoperative pain, often requiring opioid-based analgesia. However, opioid use may be associated with adverse effects such as nausea, vomiting, sedation, and respiratory depression. Therefore, optimizing postoperative pain management while minimizing opioid consumption remains an important clinical goal.Local anesthetic infiltration has been proposed as a simple and effective method for improving postoperative analgesia. Bupivacaine, a long-acting local anesthetic, may provide prolonged pain control when administered at surgical sites.This randomized clinical study was conducted to evaluate the effect of pre-extubation infiltration of bupivacaine on postoperative pain and opioid consumption in patients undergoing orthognathic surgery. Patients undergoing one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy were randomly assigned to either a control group receiving standard care or a study group receiving additional infiltration of 0.5% bupivacaine with epinephrine at surgical sites prior to extubation.Postoperative pain was assessed using a visual analogue scale at predefined time points over a 48-hour period. Morphine consumption, including total and rescue doses, was recorded during the first 24 hours.It was hypothesized that pre-extubation bupivacaine infiltration would reduce postoperative pain intensity and opioid requirements compared with standard care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two group; study vs control
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Experimental | Drug: Bupivacaine InfiltrationPatients received standard perioperative care along with pre-extubation infiltration of 0.5% bupivacaine with epinephrine at the surgical sites |
| Control group | Active comparator | Drug: Standard medical treatmentPatients received standard perioperative care without pre-extubation bupivacaine infiltration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-II, age between 18 and 65 years, and planned one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy
Key exclusion criteria (1 listed)
- refusal to participate, ASA score ≥ III, congenital craniofacial anomalies, previous maxillofacial surgery, history of chronic opioid use, and allergy to local anesthetics or opioids.
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 |
|---|---|---|
| Bupivacaine InfiltrationPre-extubation local infiltration of 0.5% bupivacaine with epinephrine was administered at the surgical sites in addition to standard perioperative care | Drug | Bupivacaine group |
| Standard medical treatmentPatients received standard perioperative care without pre-extubation bupivacaine infiltration | Drug | Control group |
Primary outcome
Postoperative Pain Intensity
Time frame: Up to 48 hours after surgery
Pain intensity assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst possible pain, with higher scores indicating greater pain intensity, measured at 3, 6, 9, 12, 18, 24, 30, and 48 hours postoperatively.
Morphine Consumption
Time frame: Total and rescue morphine consumption recorded during the first 24 hours postoperatively.
Within the first 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Esra Beyler principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine Infiltration and Standard medical treatment in people with Postoperative Pain and Orthognathic Surgery, run by Esra Beyler at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 21 Apr 2026. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Up to 48 hours after surgery). The study lists 2 primary outcomes in all. 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 21 Apr 2026.