Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Dennys Rivera Pérez, MD
- 전화번호: 1920-1921 7877582525
- 이메일: dennys.rivera@upr.edu
연구 연락처 백업
- 이름: Alvara J Horta Caicedo, DMD
- 전화번호: 1-678-394-7721
- 이메일: alvaro.horta@upr.edu
연구 장소
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San Juan, 푸에르토 리코, 00936
- 모병
- Administración de Servicios Médicos (ASEM)
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연락하다:
- Dennys Rivera Pérez, MD
- 전화번호: 1920-1921 7877582525
- 이메일: dennys.rivera@upr.edu
-
연락하다:
- Alvara J Horta Caicedo, DMD
- 전화번호: 1-678-394-7721
- 이메일: alvaro.horta@upr.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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실험적: 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.
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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.
다른 이름들:
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Pain Intensity
기간: 1 hour, 4 hours, and 24 hours after surgery
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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.
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1 hour, 4 hours, and 24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Analgesic Consumption
기간: Within 24 hours after surgery
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Total amount of rescue analgesic medications administered during the postoperative period will be recorded and compared between study groups.
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Within 24 hours after surgery
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Patient Satisfaction with Pain Management
기간: 24 hours after surgery
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Patient satisfaction with postoperative pain control measured using the Spanish version of the Pain Treatment Satisfaction Scale (PTSS).
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24 hours after surgery
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2603555595
개별 참가자 데이터(IPD) 계획
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