- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07251400
Efficacité analgésique du bloc du muscle érecteur du rachis et de la gaine des droits chez les patients subissant une réparation laparoscopique de la hernie inguinale (analgesia)
L'efficacité analgésique des blocs du muscle érecteur du rachis et de la gaine du muscle droit guidés par échographie chez les patients subissant une réparation laparoscopique de hernie inguinale : un essai contrôlé randomisé
The aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Multiple factors play a critical role in the development of pain after laparoscopic bilateral inguinal hernia repair surgery. These include parietal stimulation from the surgical incision, visceral stimulation from the peritoneum, and manipulation of intra-abdominal structures. Somatic innervation of the anterior abdominal wall is provided by the thoracolumbar spinal nerves T6-L1. Innervation of the skin above the umbilicus is provided by cutaneous nerves T6 to T9. The area around the umbilicus is innervated by T10, while the underlying skin is innervated by T11, T12, and L1. The peritoneum contains "silent nociceptors" that are activated by surgical injury and intraperitoneal inflammation and contribute to visceral pain. The neuro-immuno-humoral pain pathways involved in abdominal surgery involve somatic and autonomic nerves. Parasympathetic activation and decreased vagal tone have been shown to influence perioperative outcome because they exacerbate inflammation associated with gastrointestinal dysfunction. Thoracic epidural analgesia is still considered the gold standard for postoperative analgesia in major abdominal surgery; however, concerns about the risk of major complications such as hypotension, motor block, epidural hematoma, and abscess sometimes limit its use. Intravenous morphine administration is a cornerstone of pain management, but the side effects seen after opioid use limit its use. An ideal multimodal analgesic method includes regional blocks (neuraxial blocks [epidural and paravertebral analgesia], plane blocks [transversus abdominis plane blocks and rectus sheath block], intravenous analgesic medications (nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 selective inhibitors, or single intraoperative dexamethasone), and surgical field infiltration.
Erector spinae plane block (ESPB) was first described for the treatment of thoracic neuropathic pain and has since become an effective periparavertebral regional anesthesia technique applied to prevent postoperative pain in various surgeries. ESPB was initially applied at the T5 level, but more recently has been shown to be effective in providing comprehensive somatic and visceral abdominal analgesia when applied at the T7-T9 level. It is easier to administer than thoracic epidural anesthesia and thoracic paravertebral block. The effectiveness of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy has been studied. A study evaluating ESPB with bilateral ultrasound concluded that it provides effective analgesia in patients and significantly reduces analgesia requirements, extending to up to 1 week. Bilateral rectus sheath block (RSB) provides analgesia to the anteromedial abdominal wall and periumbilical area by blocking spinal dermatomes T9, T10, and T11. RSB provides analgesia to the anterior cutaneous branches of the intercostal nerves and is therefore well-suited for postoperative analgesia for midline abdominal incisions. Although initially developed to provide anterior abdominal muscle relaxation, RSB has subsequently been used for pain relief after abdominal surgery. This fascial plane block involves the deposition of a local anesthetic between the rectus muscle and the posterior sheath to anesthetize the terminal branches of the lower thoracic spinal nerves T7-T12. A recent meta-analysis of 698 patients found that RSB improved pain control and reduced opioid consumption for up to 12 hours postoperatively, with no significant adverse events reported.
The primary objective of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair. The secondary objective was to compare opioid consumption in the postoperative period.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Umraniye
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Istanbul, Umraniye, Turquie (Türkiye), 34034
- Umraniye Education and Research Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients aged 18 and under 70 years of age
- ASA I-III
Exclusion Criteria:
- Patients with ASA IV,
- known neurological or psychiatric disorders,
- asthma or COPD,
- long-term drug or alcohol abuse,
- diabetes mellitus,
- BMI >35,
- intellectual disability,
- contraindications for EPSP or RSB,
- massive bleeding, coagulopathy
- those with significant systemic conditions undergoing emergency surgery
Plan d'étude
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: ESB (Erector spinae plane block) group
The ESP block will be applied under general anesthesia after skin closure lateral decubitus position. The ultrasound probe will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the T7 spinous process. Using the inplane technique, a 22-gauge, 80 mm needle will be advanced craniocaudally, and 30 ml of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. ESPB will be performed bilaterally, with 30 ml of local anesthetic administered to the plane of the erector spinae on each side. |
postoperative analgesia for inguinal hernia repair
Autres noms:
|
|
Comparateur actif: RSB (Bilateral rectus sheath block) group
Before recovery from anesthesia, an ultrasound-guided rectus sheath block will be performed after the skin incision is closed. the rectus sheath and the posterior aspect of the rectus abdominis muscle an 80 mm, 22-gauge short-tapered needle will be advanced anterolaterally to medially using in-plane placement with real-time assessment, Once the tip is correctly positioned in the intended plane, 20 mL of a local anesthetic, typically bupivacaine at a concentration of 0.25%, will be administered on each side for effective analgesia. |
postoperative analgesia for inguinal hernia repair
Autres noms:
|
|
Comparateur actif: LA infiltration group
Patients who will receive local anesthesia only for surgical incisions will be considered the control group. 20 ml of 0.25% bupivacaine will be applied to the surgical incisions, and no plane block will be performed |
postoperative analgesia for inguinal hernia repair
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative pain in patients undergoing laparoscopic bilateral hernia repair
Délai: 24 hours after extubation
|
VAS score |
24 hours after extubation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Postoperative Opioid Consumption
Délai: immediately after the surgery
|
remifentanyl |
immediately after the surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zeliha Alıcıkuş, asc prof, Umraniye ERH
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Zeliha20
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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