Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Cairo, Egypte, 11451
- Ahmed Abdalla Mohamed
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Physical status ASA II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.
Exclusion Criteria:
- Patient refusal.
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders and/or chronic pain.
- Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
- Significant liver or renal insufficiency.
- Localized infection at the site of block.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Paravertebral group (group P):
After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost.
|
In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals. Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
Autres noms:
|
|
Expérimental: Control group (group C):
Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol).
|
In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals. Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total intraoperative fentanyl consumption.
Délai: 24 hours
|
Total intraoperative fentanyl consumption.
|
24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.
Délai: 24 hours
|
Visual Analouge Scaleat 0 , 4 , 8 ,12 ,24 hours postoperatively.The VAS consists of a 10-cm line, with anchors at either end.
One end is marked "no pain" and the other end is marked "the worst imaginable pain".
The patient marks the place on the line to indicate his or her pain intensity.
The clinician then measures the line with a ruler and assigns a score.
|
24 hours
|
|
Heart rate and mean arterial blood pressure .
Délai: 24 hours
|
Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)
|
24 hours
|
|
Morphine consumption postoperatively for 24 hours..
Délai: 24 hours Postoperative
|
Morphine consumption per mg postoperatively for 24 hours..
|
24 hours Postoperative
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Enas Mohamed Samir, M.D, Cairo University
- Directeur d'études: Walaa Y Elsabeeny, M.D, National Cancer Institute, Cairo University
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
- MS-270-2019
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
produit fabriqué et exporté des États-Unis.
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 .