Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management

30 décembre 2021 mis à jour par: Nevert Adel, Mansoura University

Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management: A Randomized Controlled Trial

Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome.

Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery.

Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques.

Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks.

ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae.

The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.

Patients more than 18 years old of both genders with PMPS not responding to medical treatments, and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain)., American society of Anesthesiology Physical Status class I and II, and Body mass index ˂ 30 were included in this study.

The exclusion criteria are patient refusal, local or systemic sepsis, coagulopathy, unstable cardiovascular and respiratory diseases, previous neurological deficits, history of psychiatric disorders, history of drug abuse, distorted local anatomy, and those who were allergic to the used medications were excluded from the study.

All the patients will inform about the numerical rating score (NRS) from zero to 10 (where 0 no pain, 10 the worst pain) to describe their pain.

Random selection of patients:

The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.

Grouping:

Group A: receive ESR with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).

Group B: receive ESR with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).

Type d'étude

Interventionnel

Inscription (Anticipé)

50

Phase

  • Phase 2

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: yahya m wahba, assist professor
  • Numéro de téléphone: 01211313554
  • E-mail: yahyawahba@ymail.com

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Egypte
      • Mansoura, Egypte
        • Recrutement
        • Nevert adel
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • ghada F Amer, MD

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 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Patients more than 18 years old of both genders
  • with post-mastectomy pain syndrome not responding to medical treatments,
  • and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
  • American society of Anesthesiology Physical Status class I and II,
  • and Body mass index ˂ 30 were included in this study

Exclusion Criteria:

  • patient refusal,
  • local or systemic sepsis,
  • coagulopathy,
  • unstable cardiovascular
  • and respiratory diseases,
  • previous neurological deficits,
  • history of psychiatric disorders,
  • history of drug abuse,
  • distorted local anatomy,
  • and those who were allergic to the used medications

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
Comparateur actif: Group 20 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).
Autre: erector spinae block
The patients will do the procedure under fluoroscopic guidance. The patients were placed in prone position. After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine. A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level. Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected. Then another photo will be taken with the fluoroscopy to determine the level of spread in each group. After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.
Comparateur actif: Group 30 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).
Autre: erector spinae block
The patients will do the procedure under fluoroscopic guidance. The patients were placed in prone position. After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine. A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level. Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected. Then another photo will be taken with the fluoroscopy to determine the level of spread in each group. After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The level spread of each volume.
Délai: immediately after injection. C arm photo will be taken to know the level of distribution
The level spread of each volume.
immediately after injection. C arm photo will be taken to know the level of distribution
Numerical analogue scale
Délai: after 4 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 4 weeks from procedure
Numerical analogue scale
Délai: after 8 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 8 weeks from procedure
Numerical analogue scale
Délai: after 12 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 12 weeks from procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient satisfaction
Délai: after 4 weeks from the procedure
evaluated by using a linear scale in which 0 is very dissatisfied and 10 is very satisfied.
after 4 weeks from the procedure

Collaborateurs et enquêteurs

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

Parrainer

Mansoura University

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 (Réel)

12 décembre 2021

Achèvement primaire (Anticipé)

1 juin 2022

Achèvement de l'étude (Anticipé)

1 septembre 2022

Dates d'inscription aux études

Première soumission

13 décembre 2021

Première soumission répondant aux critères de contrôle qualité

30 décembre 2021

Première publication (Réel)

14 janvier 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 décembre 2021

Dernière vérification

1 décembre 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • R.21.11.1523

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Cancer du sein

Essais cliniques sur erector spinae block

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Djibouti

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner