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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Mexico City
-
Mexico City、Mexico City、メキシコ、09360
- Hospital Regional "General Ignacio Zaragoza," ISSSTE
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Tapentadol
Oral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg).
|
Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).
|
|
アクティブコンパレータ：Pregabalin
Oral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg).
|
Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity by Numeric Rating Scale (NRS)
時間枠：At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
|
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.
|
At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rescue morphine consumption
時間枠：During the two-hour PACU observation period (T0-T4)
|
Proportion of patients requiring rescue analgesia (morphine 4 mg IV) and total morphine consumption (mg) in each group.
|
During the two-hour PACU observation period (T0-T4)
|
|
Incidence of nausea and vomiting
時間枠：During the two-hour PACU observation period (T0-T4)
|
Proportion of patients experiencing nausea and/or vomiting in each group, assessed by clinical observation and patient report.
|
During the two-hour PACU observation period (T0-T4)
|
|
Hypersensitivity reactions
時間枠：From first dose of study medication through 24 hours post-surgery
|
Incidence of any hypersensitivity or anaphylactic reaction to tapentadol or pregabalin, classified according to Müller criteria.
|
From first dose of study medication through 24 hours post-surgery
|
|
Verbal Rating Scale (VRS) pain category
時間枠：At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
|
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.
|
At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ISSSTE RPI #386-2024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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