Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively. (PENGBlock)
Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial
Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.
The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.
Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Singapore, Singapour, 169608
- Recrutement
- Pain Management Center Sinagpore General Hospital
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Contact:
- Diana Xin Hui Chan
- Numéro de téléphone: 63266162
- E-mail: diana.chan.x.h@singhealth.com.sg
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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:
- Age 60 years old and above
- Provided consent for the study
- Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
- Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
Exclusion Criteria:
- Patients with cognitive impairment or inability to give consent, or refusal to give consent
- Multiple fracture cases
- Peri-prosthetic fractures and revisions
- Subclinical vertebral fractures
- Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
- Multiple trauma
- Pathological fractures secondary to metastases
Patients with contraindications to block performance
- Coagulopathy as demonstrated by PT/PTT/INR
- On antiplatelets or anticoagulation
- Infection/ compromised skin integrity at site of block performance
- Allergy to local anaesthetics and opioids
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 |
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Comparateur placebo: Control
Only standard care
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Soins standards
Autres noms:
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Expérimental: Intervention group
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
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Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
Délai: 30 minutes after receiving intervention
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The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group.
Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
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30 minutes after receiving intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)
Délai: Up to 24 hours from performance of block
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It is measured at Baseline, Immediately after performance of block, 30 minutes after the lock in recovery At 60 minutes, 180 minutes and 24 hours post block in the ward
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Up to 24 hours from performance of block
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Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block
Délai: Up to 24 hours from performance of block
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Taking the recorded time taken for the pain relieve to estimate onset time using models
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Up to 24 hours from performance of block
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Total opioid use over 24 hours as a surrogate measure
Délai: Up to 24 hours from performance of block
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Using the data recorded for : Oral morphine use Intravenous morphine use for patients on PCA Doses of opioid use will be converted to morphine milligram equivalent daily dose (MEDD) for standardized comparison. |
Up to 24 hours from performance of block
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Tay E. Hip fractures in the elderly: operative versus nonoperative management. Singapore Med J. 2016 Apr;57(4):178-81. doi: 10.11622/smedj.2016071.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Mots clés
Termes MeSH pertinents supplémentaires
- Blessures et Blessures
- Blessures aux jambes
- Fracture fémorale
- Blessures à la hanche
- Fractures, Os
- Fracture de la hanche
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Anesthésiques
- Anesthésiques locaux
- Ropivacaïne
Autres numéros d'identification d'étude
- 2 (Instituto Cardiovascular de Buenos Aires)
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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