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L'essai clinique NCT07198412 pour Gestion de la douleur, Postoperative Acute Pain, Douleur chronique au dos est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain
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L'étude clinique NCT07198412 est un essai interventionnel pour Gestion de la douleur, Postoperative Acute Pain, Douleur chronique au dos. Son statut actuel est : en recrutement. L'étude a débuté le 1 octobre 2025 et vise à recruter 180 participants. Dirigé par Benha University, l'essai devrait être terminé d'ici le 10 mai 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 novembre 2025.
Résumé succinct
This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.
Description détaillée
Spinal anesthesia is widely used for abdominal and lower limb surgeries, yet a significant number of patients experience new back pain afterward, sometimes lasting for months. Contributing factors include needle size, multiple puncture attempts, and patient characteristics. Ultrasound guidance can improve accuracy and reduce complications, while pre-procedure sedation may lower anxiety and discomfort during the procedure.
This randomized controlled trial will include 180 adult patients scheduled for non-obstetric surgery. Participants will be divided into three groups:
Ultrasound-guided spinal anesthesia without sedation
Ultrasound-guided spinal anesthesia with sedation (midazolam)
Landmark-guided spinal anesthesia (control)
Sedation will be administered with midazolam before the spinal procedure in the sedation group. All patients will receive standardized anesthesia techniques. Pain will be assessed in the early postoperative period and during long-term follow-up (1, 3, and 6 months) using validated pain scales and questionnaires. Secondary outcomes include pain severity, number of needle attempts, procedure time, patient satisfaction, and complications such as headache or nausea.
This study will clarify whether combining ultrasound guidance with pre-procedure sedation can reduce both acute and chronic back pain after spinal anesthesia, aiming to improve patient safety, comfort, and satisfaction.
Titre officiel
Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.
Conditions
Gestion de la douleurPostoperative Acute PainDouleur chronique au dosAutres identifiants de l'essai
- RC_7.8.2025
Numéro NCT
Date de début (réel)
2025-10-01
Dernière mise à jour publiée
2025-11-17
Date de fin (estimée)
2026-05-10
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Spinal anesthesia
Ultrasound-guided anesthesia
Pre-procedure sedation
Midazolam
Chronic back pain
Ultrasound-guided anesthesia
Pre-procedure sedation
Midazolam
Chronic back pain
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifArm A - Ultrasound-Guided Spinal Anesthesia (No Sedation) | Ultrasound-guided Spinal Anesthesia Spinal anesthesia performed under real-time ultrasound guidance using a curvilinear ultrasound probe and 25-27G pencil-point spinal needle. Intrathecal injection of bupivacaine 0.5% hyperbaric (12-15 mg) following local infiltration with lidocaine 1% (2-3 mL). |
ExpérimentalArm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam) | Midazolam Plus Ultrasound-guided Spinal Anesthesia Patients will receive midazolam (0.02-0.05 mg/kg IV; max 5 mg) 5-10 minutes prior to spinal anesthesia. Ultrasound guidance used for spinal needle placement. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration. Oxygen supplementation at 2 L/min and standard monitoring. |
Comparateur placeboArm C - Landmark-Guided Spinal Anesthesia (Control) | Landmark-guided Spinal Anesthesia Spinal anesthesia performed using the traditional landmark palpation technique without ultrasound guidance or sedation. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration, using a 25-27G pencil-point spinal needle. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Incidence of Postoperative Back Pain | Presence of pain or discomfort at the lower back or puncture site, assessed using a pain body map and Numeric Rating Scale (0-10). Evaluations will be performed both in the early postoperative period and during follow-up. | 24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Severity of Postoperative Back Pain | Intensity of back pain rated using the Numeric Rating Scale (0-10). | 24-48 hours; 1 month, 3 months, and 6 months postoperatively |
Number of Needle Insertion Attempts | Documented as single attempt versus multiple attempts (\>2). | During the procedure |
Patient Satisfaction | Patient-reported satisfaction assessed using a 5-point Likert scale. | 24 hours postoperatively |
Procedure-Related Complications | Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits. | Within 7 days postoperatively |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Adults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) ≤ 35 kg/m² Scheduled for elective non-obstetric lower abdominal or lower limb surgery under spinal anesthesia Able to provide written informed consent
Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at puncture site) Pre-existing chronic low back pain Chronic opioid use Known allergy or contraindication to study medications (bupivacaine, lidocaine, midazolam) Psychiatric or neurological disorders affecting pain perception or reporting Severe spinal deformities or history of previous spinal surgery Inability to comply with follow-up assessments
Benha UniversityPartie responsable de l'essai
Samar Rafik Mohamed Amin, Investigateur principal, Assistant professor of anesthesia and intensive care, Benha University
Contact central de l'essai
Contact: Samar R Amin, M.D., +201287793991, [email protected]
1 Centres de l'essai dans 1 pays
Qalyubia Governorate
Benha University Hospital, Banhā, Qalyubia Governorate, 13511, Egypt
Samar R Amin, MD, Contact, +201287793991, [email protected]
En recrutement