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Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial

24 novembre 2014 mis à jour par: Min Su, First Affiliated Hospital of Chongqing Medical University
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. So the purpose of this study is to determine whether Calot's Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing the incidence of chronic pain after LC.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.

This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.

Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.

Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.

The primary outcome of this study is the incidence of chronic pain after LC.

The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.

This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.

Type d'étude

Interventionnel

Inscription (Anticipé)

140

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Dong Zhang, Master
  • Numéro de téléphone: +86-23-89011061
  • E-mail: zdcqmua420@163.com

Lieux d'étude

  • Chine
    • Chongqing
      • Chongqing, Chongqing, Chine, 400016
        • China,Chongqing The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.

Exclusion Criteria:

  • age below 18 years or over 65 years
  • American Society of Anesthesiologists grade III or greater
  • Diabetes
  • chronic pain of any kind other than gallbladder disease
  • allergic to local anesthetics
  • cognitive impairment or communication problems
  • peptic ulcer
  • received opioids、NSAID or tranquilizers (treatment for over 1 wk before the cholecystectomy)
  • history of alcohol or drug abuse
  • the operation was converted to an open procedure
  • gangrenous cholecystitis
  • common bile duct exploration or insertion of a T-drain
  • other invasive procedures
  • severe hepatic or renal impairment
  • post-operative severe complications(e.g. pyogenic infection)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: CTB group
Participants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively. CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total.
Procédure: CTB group
CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
Comparateur actif: PCIA group
Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
Procédure: Groupe PCIA
La formule du PCIA comprenait du tramadol 800 mg, du flurbiprofène axétil 100 mg avec une solution saline ajoutée jusqu'à un volume de 80 ml au total. La pompe PCIA a été configurée avec une dose de charge de 5 ml, une dose de bolus de 2 ml, un intervalle de verrouillage de 15 min et une perfusion de fond à un débit de 1 ml/h.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Chronic post-surgical pain
Délai: 3 months post-operatively
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
3 months post-operatively

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acute pain post-operatively
Délai: 2h,4h,6h,12h,24h, 48h post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
2h,4h,6h,12h,24h, 48h post-operatively
Analgesic Rescue
Délai: from 2h to 48h post-operatively
The dosages of opioid or non-opioid analgesic rescue medications
from 2h to 48h post-operatively
Adverse events associated with post-operative analgesia
Délai: from 2h to 48h post-operatively
incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
from 2h to 48h post-operatively
moderate-severe pain
Délai: 3,6months postoperatively
Pain intensity will be measured by numerical rating scale (NRS)
3,6months postoperatively
chronic post-surgical pain
Délai: 6months postoperatively
chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain
6months postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

First Affiliated Hospital of Chongqing Medical University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2014

Achèvement primaire (Anticipé)

1 août 2015

Achèvement de l'étude (Anticipé)

1 novembre 2015

Dates d'inscription aux études

Première soumission

19 novembre 2014

Première soumission répondant aux critères de contrôle qualité

21 novembre 2014

Première publication (Estimation)

25 novembre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 novembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 novembre 2014

Dernière vérification

1 novembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CYYYMZ-005

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