Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Официальное название

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block

Обзор

Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.

Подробное описание

Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.

In this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.

After signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.

The main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).

Вмешательства

• Препарат Epidural analgesia
  All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.
• Препарат Bilateral rectus sheath block
  Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump
• Процедура Laparotomy
  A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy

Первичные конечные точки

• Change in total QoR-15 score [Срок оценки: Postoperative day 2]

Вторичные конечные точки (12)

• Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery [Срок оценки: Postoperative days 1, and 3]
• Efficacy of postoperative analgesia [Срок оценки: Day 0 and Postoperative days 1, 2, 3 and 30]
• Impact of arterial hypotension [Срок оценки: Postoperative days 1, 2 and 3]
• Impact of orthostatic hypotension [Срок оценки: Postoperative days 1, 2 and 3]
• Occurrence of nausea and/or vomiting [Срок оценки: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days]
• Postoperative complications link to analgesic technique [Срок оценки: Postoperative days 1, 2 and 3]
• The length of stay [Срок оценки: at hospital discharge up to 30 days]
• Return to normal bowel function [Срок оценки: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days]
• The quantity of morphine or equivalent [Срок оценки: Day 0 and Postoperative days 1, 2 and 3]
• Urinary catheterization [Срок оценки: at hospital discharge up to 30 days]
• Total distance covered [Срок оценки: Postoperative days 1, 2 and 3]
• Failure to set up a catheter [Срок оценки: Postoperative day 1]

Критерии участия

Критерии включения

• ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
• Have given an informed written consent
• Able to read and understand french language
• Affiliation to a social security system

Критерии исключения

• Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),
• Epidural analgesia contraindication
• With impossibility to set up bilateral rectus sheath block
• Participation in another clinical study
• Pregnant women
• Patients deprived of their liberty by a judicial or administrative decision,
• Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

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

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHR Metz Thionville Hopital de Mercy — Metz
• CHR Metz-Thionville Hopital Bel Air — Thionville

Публикации

• Maury T, Elnar A, Marchionni S, Frisoni R, Goetz C, Becret A. Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial. BMJ Open. 2023 May 23;13(5):e069736. doi: 10.1136/bmjopen-2022-069736. PMID 37221022

Идентификаторы

NCT: NCT04985695 · 2021-01-CHRMT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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