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NCT Number: NCT07518225

Pre-Extubation Bupivacaine for Pain Control 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Medical Treatment

Drug

Patients received standard perioperative care without pre-extubation bupivacaine infiltration

Primary outcomes

  1. 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.

  2. Morphine Consumption

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

    Within the first 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Esra Beyler

Other

Collaborators

  • Baskent University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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