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Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

NCT07571252 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-12-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571252 on ClinicalTrials.gov