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Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

27 augusti 2026 uppdaterad av: Hector Torres Pérez, University of Puerto Rico

Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.

This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication.

The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control.

This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Effective management of postoperative pain remains an important component of perioperative care in patients undergoing orthognathic surgery. Procedures such as bilateral sagittal split osteotomy and Le Fort I osteotomy are associated with significant postoperative discomfort due to extensive manipulation of osseous and soft tissue structures. Preemptive analgesia, defined as the administration of analgesic medication prior to surgical injury, has been proposed as a strategy to attenuate central sensitization and reduce postoperative pain intensity.

This study is designed as a participant-blinded, randomized controlled clinical trial conducted in the operating room at the Administration of Medical Services in Puerto Rico (ASEM). Adult patients between 21 and 65 years of age with American Society of Anesthesiologists (ASA) physical status I or II who are scheduled to undergo orthognathic surgery will be invited to participate following informed consent. A total of 72 participants will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving no preoperative analgesic intervention.

Participants in the intervention groups will receive either acetaminophen 1 g intravenously or ibuprofen 600 mg intravenously approximately 30 minutes before surgical incision, with a second dose administered near the end of the procedure according to the medication half-life. The control group will receive no pre-surgical analgesic administration and will follow the institution's standard postoperative pain management protocol.

Postoperative pain intensity will be measured using a validated pain scale at predetermined intervals during the postoperative period. Additional outcomes include postoperative analgesic requirements and patient satisfaction with pain control. By comparing two commonly used intravenous analgesic medications with standard care, this study aims to evaluate the effectiveness of preemptive analgesic strategies in improving postoperative pain outcomes and reducing analgesic consumption following orthognathic surgery.

Studietyp

Interventionell

Inskrivning (Beräknad)

72

Fas

  • Fas 4

Kontakter och platser

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Studiekontakt

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Studieorter

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Rekrytering
        • Administración de Servicios Médicos (ASEM)
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Adults aged 21 to 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Renal dysfunction, defined as estimated glomerular filtration rate <60 mL/min/1.73 m².
  • Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.
  • History of bleeding disorders or coagulopathy.
  • Active or recent peptic ulcer disease.
  • Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.
  • Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intravenous Acetaminophen
Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
Läkemedel: Acetaminophen
Acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Andra namn:
  • Acetaminophen 1g Iv
  • Acetaminophen 1000mg IV
Experimentell: Intravenous Ibuprofen
Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
Läkemedel: ibuprofen
Ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Andra namn:
  • Ibuprofen 600mg IV
Inget ingripande: Standard Care Control
Participants randomized to this arm will not receive preoperative analgesic medication. Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure. Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Intensity
Tidsram: 1 hour, 4 hours, and 24 hours after surgery
Postoperative pain intensity measured using a validated pain scale (Visual Analog Scale, 0-10) in patients undergoing orthognathic surgery. Pain scores will be recorded and compared between the acetaminophen, ibuprofen, and control groups.
1 hour, 4 hours, and 24 hours after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Analgesic Consumption
Tidsram: Within 24 hours after surgery
Total amount of rescue analgesic medications administered during the postoperative period will be recorded and compared between study groups.
Within 24 hours after surgery
Patient Satisfaction with Pain Management
Tidsram: 24 hours after surgery
Patient satisfaction with postoperative pain control measured using the Spanish version of the Pain Treatment Satisfaction Scale (PTSS).
24 hours after surgery

Samarbetspartners och utredare

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Sponsor

University of Puerto Rico

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 februari 2027

Studieregistreringsdatum

Först inskickad

29 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2603555595

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared because the dataset contains potentially identifiable health information and the study protocol does not include provisions for external data sharing.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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