Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery
Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial
연구 개요
상세 설명
Acute postoperative pain affects over 80% of surgical patients, with orthopaedic lower limb procedures causing particularly severe pain. Preemptive analgesia may attenuate central sensitisation before surgical incision. Tapentadol (μ-opioid agonist + norepinephrine reuptake inhibitor) and pregabalin (voltage-gated calcium channel modulator) are pharmacologically distinct options, but direct comparative data are lacking.
This single-centre, double-blind, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Forty-six patients (ASA I-II, age 18-50 years, BMI 18-35 kg/m²) scheduled for elective lower limb surgery under neuraxial anaesthesia were randomised 1:1 to receive either tapentadol 50 mg orally every 12 hours (n=23) or pregabalin 75 mg orally every 24 hours (n=23), both initiated 72 hours before surgical incision.
The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at PACU arrival (T0) and at 30 (T1), 60 (T2), 90 (T3), and 120 (T4) minutes thereafter. Secondary outcomes included Verbal Rating Scale (VRS) scores, rescue morphine consumption (4 mg IV on request), and incidence of nausea/vomiting and hypersensitivity reactions. The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes are reported as Cohen's d.
The trial was approved by the institutional ethics and research committee (RPI #386-2024) and registered with the ISSSTE institutional research registry prior to enrolment. Due to institutional policy restrictions at the time of study initiation, registration on ClinicalTrials.gov was completed after data collection; this is disclosed transparently in accordance with CONSORT 2025 guidance on retrospective registration disclosure.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Mexico City
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Mexico City, Mexico City, 멕시코, 09360
- Hospital Regional "General Ignacio Zaragoza," ISSSTE
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-50 years
- ASA physical status I or II
- Body mass index between 18 and 35 kg/m²
- Scheduled for elective lower limb surgery under neuraxial anaesthesia
- Willing to provide written informed consent
Exclusion Criteria:
- Chronic use of analgesics or gabapentinoids
- Known hypersensitivity to tapentadol or pregabalin
- Pre-existing chronic pain
Elimination Criteria:
- Hypersensitivity reaction to any study drug during administration
- Hemodynamic shock of any etiology
- Requirement for advanced airway management or postoperative mechanical ventilation
- Surgical duration exceeding 120 minutes
- Requirement of an epidural catheter dose within the first two postoperative hours
- Voluntary withdrawal of consent at any point
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Tapentadol
Oral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg).
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Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).
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활성 비교기: Pregabalin
Oral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg).
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Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity by Numeric Rating Scale (NRS)
기간: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
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Postoperative pain intensity measured using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain).
The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient.
Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction.
Effect sizes reported as Cohen's d.
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At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rescue morphine consumption
기간: During the two-hour PACU observation period (T0-T4)
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Proportion of patients requiring rescue analgesia (morphine 4 mg IV) and total morphine consumption (mg) in each group.
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During the two-hour PACU observation period (T0-T4)
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Incidence of nausea and vomiting
기간: During the two-hour PACU observation period (T0-T4)
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Proportion of patients experiencing nausea and/or vomiting in each group, assessed by clinical observation and patient report.
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During the two-hour PACU observation period (T0-T4)
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Hypersensitivity reactions
기간: From first dose of study medication through 24 hours post-surgery
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Incidence of any hypersensitivity or anaphylactic reaction to tapentadol or pregabalin, classified according to Müller criteria.
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From first dose of study medication through 24 hours post-surgery
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Verbal Rating Scale (VRS) pain category
기간: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
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Pain severity categorised as absence, low, moderate, or severe using the Verbal Rating Scale (VRS).
Reported as proportions of patients in each category at each timepoint.
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At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
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공동 작업자 및 조사자
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ISSSTE RPI #386-2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
급성 수술 후 통증에 대한 임상 시험
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Tapentadol에 대한 임상 시험
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Grünenthal GmbH완전한
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Mayo ClinicNational Center for Research Resources (NCRR)완전한
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All India Institute of Medical Sciences, Bhubaneswar완전한