Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy (LIDO-APP)
Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
연구 개요
상세 설명
Postoperative pain following laparoscopic appendectomy remains an important clinical concern despite advances in multimodal analgesia. Intravenous lidocaine has been proposed as an effective adjunct because of its analgesic, anti-inflammatory, and antihyperalgesic properties, but evidence in laparoscopic appendectomy remains limited.
This prospective, randomized, double-blind, placebo-controlled trial compared continuous intraoperative intravenous lidocaine infusion with placebo in patients undergoing laparoscopic appendectomy under standardized general anesthesia. Patients were randomly allocated to receive either lidocaine or placebo according to the study protocol.
The primary outcome was postoperative pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included opioid requirements, postoperative nausea and vomiting, return of bowel function, length of hospital stay, incidence of adverse events, and perioperative plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points.
The study aimed to determine the clinical efficacy and safety of intravenous lidocaine infusion as part of multimodal perioperative analgesia for laparoscopic appendectomy and to correlate analgesic effects with measured plasma lidocaine concentrations.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Miranda
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Caracas, Miranda, 베네수엘라, 1040
- Hospital Universitario de Caracas
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 45 years.
- ASA physical status I or II.
- Scheduled for laparoscopic appendectomy under general anesthesia.
- Able to provide written informed consent.
Exclusion Criteria:
- History of cardiac conduction disorders or documented arrhythmias.
- Hepatic insufficiency.
- Renal insufficiency.
- Chronic or long-term opioid therapy.
- Known or suspected hypersensitivity to amide-type local anesthetics.
- Hemodynamic instability at the time of admission to the operating room.
- Body mass index greater than 35 kg/m².
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intravenous lidocaine group
Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.
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Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
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위약 비교기: Placebo group
Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.
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Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain intensity
기간: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
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Postoperative pain intensity assessed using the Visual Analogue Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate better analgesic efficacy.
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At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total opioid comsumption
기간: From surgery completion through 24 hours after surgery.
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Total postoperative opioid requirement during the first 24 hours after surgery.
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From surgery completion through 24 hours after surgery.
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Post operative nausea and vomiting
기간: From surgery completion through 24 hours after surgery.
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Incidence of postoperative nausea and vomiting requiring treatment
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From surgery completion through 24 hours after surgery.
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Time to return of bowel function
기간: From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
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Time from surgery completion to first flatus or bowel movement.
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From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
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Lengh of hospital stay
기간: From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
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Time from surgery completion until hospital discharge.
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From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
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Plasma lidocaine concentration
기간: From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
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Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.
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From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
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공동 작업자 및 조사자
수사관
- 수석 연구원: JOSEPH A VERAZA, MD, sociedad medica joseph veraza
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HUC-LIDO-APP-2024-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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