Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT00915265 Statut inconnu

Titre

Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

Type

Interventional

Pathologie

Phase

Phase 4

Promoteur

University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)

Date de début

octobre 2009

Date de fin

octobre 2018

Dernière mise à jour

29 juin 2024

Résumé

The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.

Détail

Voir le détail Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared. The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France	Patrick Lacarin	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Age > 18 years

- Open colorectal surgery through a midline incision with a primary anastomosis

- American Society of Anesthesiologists (ASA) physical status I to III

Critère de non inclusion

- Obesity (body mass index > 35 kg/m2)

- Pregnancy

- Inflammatory bowel diseases

- Contraindication for epidural analgesia (patient refusal, active sepsis,
coagulopathy)

- Chronic renal failure (with creatinin clearance < 30 ml/min)

- Significant hepatic failure (prothrombin ratio < 50%, factor V < 50%)

- Chronic pain

- Preoperative opioid consumption

- Preoperative cognitive dysfunction

- Preoperative psychiatric disorders

NCT00915265 - Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

Informations générales
Etablissements
Critères
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