Pre-Extubation Bupivacaine for Pain Control After Orthognathic Surgery

NCT07518225 | Completed

• 1 other identifier: D-KA26/14
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Orthognathic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 48 hours after surgery

• Morphine Consumption

  Within the first 24 hours after surgery

  Total and rescue morphine consumption recorded during the first 24 hours postoperatively.

Study Arms (2)

Bupivacaine group

EXPERIMENTAL

Patients received standard perioperative care along with pre-extubation infiltration of 0.5% bupivacaine with epinephrine at the surgical sites

Drug: Bupivacaine Infiltration

Control group

ACTIVE COMPARATOR

Patients received standard perioperative care without pre-extubation bupivacaine infiltration.

Drug: Standard medical treatment

Interventions

Standard medical treatment DRUG

Patients received standard perioperative care without pre-extubation bupivacaine infiltration

Control group

Bupivacaine Infiltration DRUG

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

Bupivacaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Esra Beyler: lead
• Baskent University: collaborator

Study Sites (1)

Baskent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Esra Beyler

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, anesthesiologists, and outcome assessors were blinded to group allocation, whereas the surgeons performing the procedures were not blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: two group; study vs control

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: September 2, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 2, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)