Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

NCT07571252 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2603555595
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain; Orthognathic Surgery

Keywords

Preemptive Analgesia; Orthognathic Surgery; Postoperative Pain; Maxillofacial Surgery; Multimodal Analgesia; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  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

Secondary Outcomes (2)

• Postoperative Analgesic Consumption

  Within 24 hours after surgery

• Patient Satisfaction with Pain Management

  24 hours after surgery

Study Arms (3)

Intravenous Acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen

Intravenous Ibuprofen

EXPERIMENTAL

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.

Drug: ibuprofen

Standard Care Control

NO INTERVENTION

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.

Interventions

Acetaminophen DRUG

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.

Also known as: Acetaminophen 1g Iv, Acetaminophen 1000mg IV

Intravenous Acetaminophen

ibuprofen DRUG

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.

Also known as: Ibuprofen 600mg IV

Intravenous Ibuprofen

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Administración de Servicios Médicos (ASEM)

San Juan, 00936, Puerto Rico

Location

Related Publications (3)

• Cillo JE Jr, Dattilo DJ. Pre-emptive analgesia with pregabalin and celecoxib decreases postsurgical pain following maxillomandibular advancement surgery: a randomized controlled clinical trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1909-14. doi: 10.1016/j.joms.2014.05.014. Epub 2014 May 27.

  PMID: 25234526 BACKGROUND

• Alyahya A, Aldubayan A, Swennen GRJ, Al-Moraissi E. Effectiveness of different protocols to reduce postoperative pain following orthognathic surgery: A systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Sep;60(7):e1-e10. doi: 10.1016/j.bjoms.2022.03.013. Epub 2022 Apr 23.

  PMID: 35690502 BACKGROUND

• Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Chin V, Houle TT, Wang J. Efficacy of preemptive analgesia treatments for the management of postoperative pain: a network meta-analysis. Br J Anaesth. 2022 Dec;129(6):946-958. doi: 10.1016/j.bja.2022.08.038. Epub 2022 Oct 26.

  PMID: 36404458 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Central Study Contacts

Dennys Rivera Pérez, MD

CONTACT

7877582525; dennys.rivera@upr.edu

Alvara J Horta Caicedo, DMD

CONTACT

1-678-394-7721; alvaro.horta@upr.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to their group allocation. The anesthesiologist administering the study medication in the operating room will not be blinded due to the need to prepare and administer the assigned intervention. Postoperative pain assessments and data collection will be performed by research personnel who are blinded to treatment allocation to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1:1 ratio to receive intravenous acetaminophen, intravenous ibuprofen, or no preoperative analgesia prior to orthognathic surgery. Postoperative pain outcomes will be compared between the three groups.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)