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| Name | Class |
|---|---|
| Baskent University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine group | Experimental | Patients received standard perioperative care along with pre-extubation infiltration of 0.5% bupivacaine with epinephrine at the surgical sites |
|
| Control group | Active Comparator | Patients received standard perioperative care without pre-extubation bupivacaine infiltration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esra Beyler | Baskent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Ankara | Cankaya | 06490 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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two group; study vs control
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Participants, anesthesiologists, and outcome assessors were blinded to group allocation, whereas the surgeons performing the procedures were not blinded
| Standard medical treatment | Drug | Patients received standard perioperative care without pre-extubation bupivacaine infiltration |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |