- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03673280
Quadratus Lumborum in Cesarean Section Trial (QUALICS)
Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.
Postoperative pain of a caesarean section may be of high intensity, especially in the first 48 hours after the procedure, which affects the mother / newborn relationship, in addition to having the potential to progress to chronic pain. The use of intrathecal morphine is effective in post-caesarean analgesia, but carries unwanted side effects, including nausea, vomiting, urinary retention and pruritus. Therefore, alternative techniques of analgesia become necessary.
First described in 2007, ultrasound-guided quadratus lumborum (QL) block has gained prominence due to its analgesic superiority to the TAP block. Besides providing somatic analgesia, it also seems to inhibit visceral pain because the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast medium injected at the QL block site.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
C-section is one of the most performed surgical procedures in the world, and presents great potential for postoperative pain, especially in the first 48 hours. Pain in this period represents a risk for evolution to chronic pain, but its incidence is still very divergent when comparing the studies, ranging from 1% to 18%.
The use of intrathecal morphine (MIT) is consecrated as a first-choice method of analgesia for post-partum cesarean delivery; however, its use carries relevant side effects for the puerpera, such as pruritus, nausea, urinary retention and , more rarely, respiratory depression. In the last decade, new adjunctive forms of postoperative analgesia have become more popular, such as regional blockades, highlighting the blockage of the Transversus Abdominis plane block (TAP) and the Quadratus Lumborum block (QL), taking as benefits the prolonged analgesia they provide and the low incidence of side effects. Another factor that contributes to the popularization of regional blocks is the increasing availability of ultrasound devices in the anesthetic-surgical environment. Studies evaluating TAP block after cesarean section performed under spinal anesthesia have shown a discrete benefit in decreasing postoperative opioid consumption in addition to improving pain scores. When comparing MIT with TAP block, the superiority of MIT is due to visceral analgesia while TAP block is restricted to abdominal wall analgesia.
Ultrasound-guided Lumbar Quadrant blockade has gained prominence due to its analgesic superiority over the TAP block, because in addition to providing somatic analgesia it also seems to inhibit visceral pain since the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast injected at the site of the QL block.
Reviewing the literature in 2018, there are no clinical trials comparing the use of intrathecal morphine with the quadratus lumborum block.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
São Paulo, Brésil, 05403000
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Minimum age of 18 years
- Minimum gestational age of 37 weeks with a single fetus
- Patients scheduled for elective cesarean section
Exclusion Criteria:
- Clinical contraindication to spinal anesthesia
- Morbid obesity (BMI> 35kg / m²)
- Drug addiction
- Chronic use of opioids or benzodiazepines
- Inability to understand or handle the PCA pump
- Allergy to any medication included in the protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Classical spinal anesthesia
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block.
|
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Autres noms:
|
Expérimental: Spinal anaesthesia with block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.
|
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Autres noms:
|
Expérimental: Classical anaesthesia plus block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block.
|
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Morphine consumption
Délai: 24 hours
|
Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
|
24 hours
|
Pain intensity
Délai: 24 hours
|
Verbal numeric scale
|
24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Nausea and Vomiting
Délai: 24 hours
|
Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.
|
24 hours
|
Pruritus
Délai: 24 hours
|
Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.
|
24 hours
|
Chronic pain
Délai: 3 months
|
Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.
|
3 months
|
Urinary retention
Délai: 24 hours
|
Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.
|
24 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hermann S Fernandes, MD, University of Sao Paulo
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
Autres numéros d'identification d'étude
- CAAE 90600818.0.0000.0068
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.
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 .
Essais cliniques sur Quadratus Lumborum Block
-
Hama UniversityRecrutementMalocclusion, classe d'angle IIRépublique arabe syrienne
-
Guy's and St Thomas' NHS Foundation TrustInconnueMalocclusion, classe d'angle II
-
Damascus UniversityComplétéComplication de l'appareil orthodontique | Malocclusion, Angle Classe II, Division 1République arabe syrienne
-
University of BirminghamInconnueMalocclusion, classe d'angle IIRoyaume-Uni
-
AtriCure, Inc.Inscription sur invitationDouleur post-opératoireÉtats-Unis
-
Cairo UniversityInconnueHypoplasie mandibulaire | Rétrognathisme mandibulaireEgypte
-
Alexandria UniversityComplétéChirurgie de la hanche par bloc transmusculaire du quadratus lumborumEgypte
-
Singapore General HospitalInconnueHystérectomie abdominale (& Wertheim)
-
Memorial Sloan Kettering Cancer CenterColumbia UniversityComplétéCarcinome hépatocellulaire | Cancer du foie | HépatomeÉtats-Unis
-
Nazmy Edward SeifComplétéAnalgésie | Opération | Pierre rénaleEgypte