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.

Efficacy of Ultrasound-Guided Erector Spinae Block for Postoperative Pain Management in Nephrectomy

24 avril 2026 mis à jour par: Kazi Mahzabin Arin, Bangladesh Medical University

Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Postoperative Pain Management in Nephrectomy: A Randomized Controlled Trial

This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.

Patients will be randomly assigned to one of two groups:

Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.

The main goals are to determine:

How much pain relief each method provides, measured using a visual analog scale (VAS).

The total amount of opioids required during the first 24 hours post-surgery.

Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.

This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.

This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.

The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:

Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.

Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.

The primary outcome of the trial is to measure the first postoperative opioid requirement, utilizing the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes include the total opioid consumption in the first 24 hours, the intensity of postoperative pain at various time points, and the hemodynamic responses (heart rate, blood pressure). Additionally, peak expiratory flow rate (PEFR) will be monitored to assess respiratory function as part of the recovery process.

By evaluating these outcomes, the study aims to provide insights into whether ESP block can serve as a safer, effective alternative to traditional analgesia, improving postoperative pain management and reducing the risks associated with opioid use. The results may guide clinical practice in nephrectomy pain management, offering a potential improvement in patient recovery times and satisfaction.

Type d'étude

Interventionnel

Inscription (Estimé)

66

Phase

  • N'est pas applicable

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

Sauvegarde des contacts de l'étude

Lieux d'étude

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

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adult patients aged 18 to 64 years
  • Scheduled for open nephrectomy (radical or partial) under general anesthesia
  • ASA physical status I-II (American Society of Anesthesiologists classification)

Exclusion Criteria:

  • Allergy to local anesthetics.
  • Local infection or inflammation at the site of the Block placement.
  • Presence of anatomical deformities in the spine
  • Coagulopathy or any bleeding disorder.
  • Pregnancy or breastfeeding women.
  • History of severe chronic pain syndrome

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control Group: Conventional Pain Management
This group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care
Expérimental: Intervention Group: Ultrasound-Guided Erector Spinae Plane Block
Patients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia. The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption.
Procédure: Ultrasound-Guided Erector Spinae Plane (ESP) Block
The Ultrasound-Guided Erector Spinae Plane (ESP) Block is a regional anesthesia technique used to provide postoperative pain relief. In this study, the intervention involves the administration of a local anesthetic (0.25% bupivacaine) into the fascial plane between the erector spinae muscle and the transverse process of the vertebra using ultrasound guidance. The procedure is performed immediately before the induction of general anesthesia in patients undergoing open nephrectomy. The goal of the ESP block is to reduce postoperative pain, minimize opioid consumption, and improve recovery outcomes while maintaining hemodynamic stability. This intervention is compared to conventional pain management methods, which primarily rely on systemic opioids and other standard analgesics.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Visual Analogue Scale (VAS) for pain
Délai: VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.

VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain.

A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control.
VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total Opioid Consumption
Délai: Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
Total opioid consumption will be tracked and recorded for each group during the first 24 hours post-surgery. The total amount of opioids used (in milligrams) will serve as an indicator of pain control effectiveness. A reduction in opioid consumption in the ESP block group, compared to the control group, would suggest that the ESP block is effective in reducing the need for opioids, thereby minimizing opioid-related side effects.
Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
Peak Expiratory Flow Rate (PEFR)
Délai: PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
PEFR will be measured preoperatively and at multiple points postoperatively (1, 3, 6, and 24 hours) to assess respiratory function. This is particularly important in nephrectomy patients, as effective pain management helps promote better respiratory outcomes and reduce the risk of atelectasis or other complications. A higher PEFR value suggests better lung function and recovery.
PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
Heart Rate (HR) Monitoring
Délai: Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Heart rate (HR) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). This will help assess whether the ESP block maintains hemodynamic stability without causing significant fluctuations, such as tachycardia (increased heart rate), compared to conventional analgesia methods.
Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Systolic Blood Pressure (SBP) Monitoring in mmHg
Délai: Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Systolic blood pressure (SBP) will be recorded preoperatively and at regular intervals (0, 1, 3, 6, 12, and 24 hours) postoperatively. The aim is to evaluate whether the ESP block offers better hemodynamic control by preventing significant blood pressure fluctuations compared to conventional analgesia methods.
Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Diastolic Blood Pressure (DBP) Monitoring in mmHg
Délai: Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Diastolic blood pressure (DBP) will be measured preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). Monitoring DBP helps assess the stability of the cardiovascular system and ensure that the ESP block does not lead to significant hypotension or other adverse effects on circulation.
Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Mean Arterial Pressure (MAP) Monitoring in mmHg
Délai: Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Mean arterial pressure (MAP) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). MAP is a key indicator of perfusion pressure, ensuring adequate blood flow to organs. This outcome will evaluate whether the ESP block maintains stable MAP levels compared to conventional analgesic methods.
Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

Collaborateurs et enquêteurs

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

Parrainer

Bangladesh Medical University

Les enquêteurs

  • Directeur d'études: AKM Akhtaruzzaman, MD, Bangladesh 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

Liens utiles

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)

1 septembre 2025

Achèvement primaire (Estimé)

30 juin 2026

Achèvement de l'étude (Estimé)

30 juillet 2026

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BSMMU/2025/2025

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Données/documents d'étude

  1. Protocole d'étude
    Identifiant des informations: pain.medicine@bsmmu.edu.bd

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

produit fabriqué et exporté des États-Unis.

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 .

S'abonner