Skip to content

Pre-Extubation Bupivacaine for Pain Control After Orthognathic Surgery

Effect of Pre-extubation Bupivacaine Infiltration on Postoperative Pain and Opioid Consumption After Orthognathic Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07518225
Enrollment
102
Registered
2026-04-08
Start date
2022-09-02
Completion date
2025-09-02
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthognathic Surgery, Postoperative Pain

Keywords

Orthognathic Surgery, Bupivacaine, Opioid, Pain management, Postoperative pain

Brief 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. 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

Interventions

Pre-extubation local infiltration of 0.5% bupivacaine with epinephrine was administered at the surgical sites in addition to standard perioperative care

DRUGStandard medical treatment

Patients received standard perioperative care without pre-extubation bupivacaine infiltration

Sponsors

Esra Beyler
Lead SponsorOTHER
Baskent University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants, anesthesiologists, and outcome assessors were blinded to group allocation, whereas the surgeons performing the procedures were not blinded

Intervention model description

two group; study vs control

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* refusal to participate, ASA score ≥ III, congenital craniofacial anomalies, previous maxillofacial surgery, history of chronic opioid use, and allergy to local anesthetics or opioids.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain IntensityUp to 48 hours after surgeryPain 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 ConsumptionTotal and rescue morphine consumption recorded during the first 24 hours postoperatively.Within the first 24 hours after surgery

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREsra Beyler

Baskent University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026