- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07716540
Analgesic Efficacy of Ultrasound-Guided Deep Iliacus Plane Block in Patients Undergoing Hip Fracture Surgery
Analgesic Efficacy of Ultrasound-Guided Deep Iliacus Plane Block in Patients Undergoing Hip Fracture Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Clinical Trial
Hip fracture surgery is commonly associated with moderate to severe postoperative pain, which may delay mobilization and increase the need for opioid analgesics. The deep iliacus plane block is a recently described ultrasound-guided regional anesthesia technique designed to provide analgesia by allowing local anesthetic spread toward the femoral nerve, lateral femoral cutaneous nerve, and articular branches supplying the hip.
This prospective, randomized, double-blind, sham-controlled clinical trial will evaluate the analgesic efficacy of the deep iliacus plane block in adult patients undergoing hip fracture surgery under spinal anesthesia. After surgery, participants will be randomly assigned to receive either an ultrasound-guided deep iliacus plane block with local anesthetic or a sham block with normal saline.
All participants will receive standardized multimodal postoperative analgesia, including patient-controlled analgesia. The primary objective is to determine whether the deep iliacus plane block reduces postoperative opioid consumption during the first 24 hours after surgery. Postoperative pain scores, rescue analgesic requirements, sensory distribution, motor block, nausea and vomiting, quality of recovery, patient satisfaction, and block-related complications will also be evaluated.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study is designed as a prospective, randomized, double-blind, sham-controlled clinical trial involving adult patients undergoing hip fracture surgery under spinal anesthesia.
Eligible participants will receive standard monitoring in accordance with the American Society of Anesthesiologists recommendations, including electrocardiography, noninvasive blood pressure measurement, and pulse oximetry. Spinal anesthesia will be performed under sterile conditions at the L3-L4 intervertebral level using 15 mg of isobaric bupivacaine.
Following completion of surgery, while the sensory effects of spinal anesthesia are still present, participants will be randomly allocated to one of two parallel study groups. Randomization will be performed using a computer-generated allocation sequence, and group assignments will be concealed using sequentially prepared sealed envelopes.
Participants assigned to the intervention group will receive an ultrasound-guided deep iliacus plane block on the surgical side. A low-frequency curvilinear ultrasound transducer will be positioned over the anterior hip region to identify the anterior inferior iliac spine, iliopubic eminence, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures. After identification of the target plane between the iliopsoas muscle and the anterior inferior iliac spine, a peripheral nerve block needle will be advanced using an in-plane approach. Following confirmation of appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered.
Participants assigned to the control group will undergo an identical ultrasound-guided procedure and will receive 30 mL of normal saline as a sham block. Participants and postoperative outcome assessors will remain blinded to group allocation. The anesthesiologist performing the study intervention will not participate in postoperative outcome assessment.
All participants will receive a standardized multimodal postoperative analgesic regimen. Intravenous patient-controlled analgesia will contain tramadol at a concentration of 4 mg/mL, without a background infusion. The device will deliver 20 mg tramadol per patient-initiated bolus, with a 20-minute lockout interval and a maximum dose of 200 mg over four hours. Intravenous paracetamol 1 g will be administered routinely at the sixth postoperative hour. Intravenous dexketoprofen 50 mg will be provided as rescue analgesia when clinically required.
The primary outcome will be cumulative tramadol consumption during the first 24 postoperative hours. Pain intensity will be evaluated using the 0-10 Numerical Rating Scale, where 0 represents no pain and 10 represents the worst imaginable pain. Pain scores at rest and during movement will be recorded at predefined postoperative time points.
The sensory distribution of the block will be assessed approximately two hours after surgery, after resolution of the residual sensory effects of spinal anesthesia. Cold sensation will be evaluated using an alcohol-based swab over relevant lower-extremity and abdominal dermatomes. Participants will be asked to report any reduction, alteration, or loss of cold sensation compared with unaffected areas.
Additional outcomes will include rescue analgesic requirements, time to first rescue analgesia, patient-controlled analgesia demand frequency, presence and severity of motor block, postoperative nausea and vomiting, antiemetic requirements, block performance time, block-related complications, patient satisfaction, quality of recovery assessed using the Quality of Recovery-15 questionnaire at 24 hours, and duration of hospital stay.
The study aims to determine whether adding the deep iliacus plane block to standardized multimodal analgesia provides superior postoperative analgesia and reduces opioid requirements compared with standardized multimodal analgesia combined with a sham block.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Engin ihsan Turan, principal investigator
- Numéro de téléphone: +905382431114
- E-mail: enginihsan@hotmail.com
Lieux d'étude
-
-
Istanbul
-
Istanbul, Istanbul, Turquie (Türkiye), 34303
- Recrutement
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
-
Contact:
- Engin ihsan Turan
- Numéro de téléphone: 05382431114
- E-mail: enginihsan@hotmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18 years or older
- Scheduled to undergo unilateral hip fracture surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand and use the Numerical Rating Scale and patient-controlled analgesia device
- No contraindication to spinal anesthesia or the deep iliacus plane block
- Written informed consent provided by the participant or legally authorized representative
Exclusion Criteria:
- ASA physical status IV or higher
- Emergency surgery
- Coagulopathy, bleeding diathesis, or anticoagulant treatment that contraindicates spinal anesthesia or peripheral nerve block
- Infection at the planned needle insertion site
- Known allergy to local anesthetics or any study medication
- Pre-existing peripheral neuropathy, neurological disorder, or motor deficit involving the operated lower extremity
- Inability to understand or use the Numerical Rating Scale or patient-controlled analgesia device
- Cognitive impairment or communication difficulty preventing reliable postoperative assessment
- Refusal to participate
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: Deep Ilacus plane block group
Participants assigned to this group will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side after completion of hip fracture surgery.
The block will be performed using 30 mL of 0.25% bupivacaine.
All participants will also receive standardized spinal anesthesia and multimodal postoperative analgesia, including intravenous patient-controlled analgesia with tramadol.
|
Following completion of surgery, participants will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side.
A low-frequency curvilinear ultrasound transducer will be used to identify the anterior inferior iliac spine, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures.
A 22-gauge, 100-mm block needle will be advanced using an in-plane approach into the target plane between the iliopsoas muscle and the anterior inferior iliac spine.
After confirmation of the appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered.
|
|
Comparateur placebo: Sham Control Group
Participants assigned to this group will undergo an identical ultrasound-guided deep iliacus plane block procedure on the surgical side and will receive 30 mL of normal saline as a sham intervention.
All participants will also receive standardized spinal anesthesia and the same multimodal postoperative analgesic regimen, including intravenous patient-controlled analgesia with tramadol.
|
Participants will undergo an identical ultrasound-guided unilateral deep iliacus plane block procedure on the surgical side.
The same anatomical landmarks, ultrasound approach, needle type, and target plane will be used.
After confirmation of the appropriate needle-tip position, 30 mL of normal saline will be administered as the sham intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Délai: From completion of surgery to postoperative hour 24
|
The total amount of tramadol, expressed in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 hours after surgery will be recorded.
The patient-controlled analgesia solution will contain tramadol at a concentration of 4 mg/mL, with a 20 mg bolus dose, a 20-minute lockout interval, no background infusion, and a maximum limit of 200 mg over four hours.
Lower cumulative consumption indicates a lower postoperative opioid requirement.
|
From completion of surgery to postoperative hour 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Numerical Rating Scale Pain Scores at Rest
Délai: At postoperative hours 1, 6, 12, and 24
|
Postoperative pain intensity at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Scores will be recorded separately at each predefined postoperative assessment time.
|
At postoperative hours 1, 6, 12, and 24
|
|
Postoperative Numerical Rating Scale Pain Scores During Movement
Délai: At postoperative hours 1, 6, 12, and 24
|
Postoperative pain intensity during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Scores will be recorded separately at each predefined postoperative assessment time.
|
At postoperative hours 1, 6, 12, and 24
|
|
Requirement for Rescue Analgesia During the First 24 Postoperative Hours
Délai: During the first 24 postoperative hours
|
The number and proportion of participants requiring at least one dose of rescue analgesia during the first 24 hours after surgery will be recorded.
Intravenous dexketoprofen 50 mg will be administered as rescue analgesia when required despite the standardized multimodal analgesic regimen.
|
During the first 24 postoperative hours
|
|
Cumulative Dexketoprofen Consumption During the First 24 Postoperative Hours
Délai: During the first 24 postoperative hours
|
The total amount of intravenous dexketoprofen administered as rescue analgesia during the first 24 hours after surgery will be recorded in milligrams.
Each rescue dose will consist of 50 mg of intravenous dexketoprofen.
|
During the first 24 postoperative hours
|
|
Dermatomal Distribution of Sensory Blockade Assessed by Cold Sensation
Délai: At postoperative hour 2
|
The sensory distribution of the assigned intervention will be evaluated using a cold sensation test with ice cubes after the residual sensory effects of spinal anesthesia have resolved.
Relevant lower-extremity and abdominal dermatomes will be assessed, and dermatomes showing reduced, altered, or absent cold sensation will be recorded.
|
At postoperative hour 2
|
|
Incidence of Postoperative Nausea and Vomiting
Délai: During the first 24 postoperative hours, assessed at hours 1, 6, 12, and 24
|
The occurrence of nausea, vomiting, or both during the first 24 hours after surgery will be recorded.
Results will be reported as the number and proportion of participants experiencing at least one episode of postoperative nausea or vomiting.
|
During the first 24 postoperative hours, assessed at hours 1, 6, 12, and 24
|
|
Quality of Recovery-15 Score at 24 Hours After Surgery
Délai: At postoperative hour 24
|
Postoperative quality of recovery will be evaluated using the Turkish validated Quality of Recovery-15 questionnaire.
The total questionnaire score will be recorded, with higher scores indicating better postoperative recovery.
|
At postoperative hour 24
|
|
Incidence of Postoperative Motor Block
Délai: At postoperative hours 6 and 24
|
Quadriceps muscle strength in the operated lower extremity will be assessed using a six-point Manual Muscle Testing scale based on the participant's ability to actively extend the knee: 0, no detectable quadriceps muscle activity; 1, trace muscle activity without joint movement; 2, active knee extension possible only with gravity eliminated; 3, active knee extension against gravity but not against external resistance; 4, active knee extension against gravity and moderate manual resistance; and 5, normal muscle strength against full manual resistance.
Higher scores indicate better preservation of quadriceps motor function.
Assessments will be performed by an outcome assessor masked to group allocation.
|
At postoperative hours 6 and 24
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Manifestations neurocomportementales
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Agnosie
- Produits chimiques organiques
- Préparations pharmaceutiques
- Anilides
- Amides
- Composés aniline
- Amines
- Solutions cristalloïdes
- Solutions isotoniques
- Solutions
- Bupivacaïne
- Solution saline
Autres numéros d'identification d'étude
- Deep Iliac
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .