Меню
Набор скоро начнётся NCT07064993

Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy

Фаза IV С лечением Knee Arthroscopy Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Saline, Tramadol, Tramadol + Dexamethasone.
Кому может быть актуально
Состояния в реестре: Knee Arthroscopy, Postoperative Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Effects of Intraarticular Tramadol and Tramadol Plus Dexamethasone on Postoperative Pain After Knee Arthroscopy

Обзор

Patients scheduled for elective knee arthroscopy under general anesthesia will be randomly assigned into three groups in a 1:1:1 ratio: placebo (saline), tramadol, and tramadol plus dexamethasone. At the end of surgery, after aspiration of the irrigation fluid, the study solution will be administered intraarticularly in a standardized volume. The primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence of adverse effects such as nausea, vomiting, itching, and shivering. This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this analgesic effect.

Подробное описание

Postoperative pain remains a significant concern following knee arthroscopy, even in minimally invasive procedures. Various intraarticular agents have been investigated to improve postoperative analgesia, reduce opioid consumption, and enhance patient comfort. Tramadol, a centrally acting analgesic with additional peripheral effects, has been shown to provide analgesia when administered intraarticularly. Dexamethasone, a corticosteroid with anti-inflammatory properties, may enhance analgesic efficacy when used as an adjuvant.

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the postoperative analgesic effects of intraarticular tramadol and tramadol combined with dexamethasone in patients undergoing elective knee arthroscopy.

A total of 120-135 patients aged 18-65 years with ASA physical status I-II scheduled for knee arthroscopy under general anesthesia will be included. Patients will be randomly assigned into three groups in a 1:1:1 ratio using a computer-generated block randomization method.

At the end of the surgical procedure, after aspiration of the irrigation fluid and before closure of the portal, the study solutions will be administered intraarticularly in a standardized volume of 20 mL. The groups will be as follows: placebo (normal saline), tramadol (100 mg), and tramadol (100 mg) combined with dexamethasone (8 mg). All study solutions will be prepared by an independent investigator in identical syringes to ensure blinding of patients, surgeons, anesthesiologists, and outcome assessors.

All patients will receive standardized general anesthesia and postoperative analgesia protocols. VAS at 0 hour is measured only when Ramsay Sedation Score ≤3. Total irrigation volume (L) is recorded.Intraoperative analgesia is standardized: fentanyl 1 mcg/kg at induction, additional 0.5 mcg/kg as needed (max 3 mcg/kg total). All patients receive IV paracetamol 15 mg/kg before extubation. Total intraoperative fentanyl dose is recorded.

The primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Rescue analgesia will be administered as IV dexketoprofen 50 mg if VAS ≥4. Pain will be reassessed after 30 minutes; if VAS remains ≥4, a second dose may be administered. The minimum interval between doses will be 30 minutes, with a maximum total dose of 150 mg within 24 hours. Total dexketoprofen consumption will be recorded. Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence and severity of adverse effects such as nausea, vomiting, itching, shivering, and potential complications.

This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this effect, thereby contributing to improved postoperative pain management strategies in knee arthroscopy. To ensure procedural homogeneity, only minor arthroscopic procedures such as partial meniscectomy will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.

Вмешательства

  • Препарат Saline
    20 mL of normal saline administered intraarticularly at the end of surgery.
  • Препарат Tramadol
    Tramadol 100 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.
  • Препарат Tramadol + Dexamethasone
    Tramadol 100 mg combined with dexamethasone 8 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

Первичные конечные точки

  • Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours) [Срок оценки: 0, 2, 6, 12, 24 hours postoperatively]
Вторичные конечные точки (7)
  • Time to first analgesic requirement [Срок оценки: Within 24 hours postoperatively]
  • Total analgesic consumption [Срок оценки: 24 hours postoperatively]
  • Postoperative nausea severity (0-3 scale) [Срок оценки: 24 hours postoperatively]
  • Number of vomiting episodes [Срок оценки: 24 hours postoperatively]
  • Postoperative itching severity (0-3 scale) [Срок оценки: 24 hours postoperatively]
  • Postoperative shivering severity (0-3 scale) [Срок оценки: 24 hours postoperatively]
  • Adverse events [Срок оценки: Up to 30 days postoperatively]

Критерии участия

Критерии включения

Patients aged 18-65 years ASA physical status I-II Scheduled for elective knee arthroscopy under general anesthesia Only minor arthroscopic procedures such as partial meniscectomy will be included Ability to provide informed consent

Критерии исключения

Allergy or contraindication to tramadol or dexamethasone Chronic opioid use or chronic pain conditions History of psychiatric or neurological disorders that may affect pain perception Severe hepatic or renal impairment Pregnancy or breastfeeding Infection at the injection site Bleeding diathesis Refusal to participate Major reconstructive knee surgeries (e.g., anterior cruciate ligament reconstruction)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation — Van

Идентификаторы

NCT: NCT07064993 · 19.11.2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗