Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia
Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial
Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.
The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.
We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
- ASA physical status 1 - 3
- Written informed consent
- Gestational age ≥ 37 weeks.
Exclusion Criteria:
- Patient's refusal.
- Body mass index ≥ 45
- Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Palpation
Palpation will be used to determine placement of the spinal needle.
|
|
|
Expérimental: Ultrasound
Ultrasound will be used prior to placement of the spinal needle.
|
Ultrasound applied to the lumbar region to determine spinal needle placement.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Spinal needle redirections
Délai: 15 minutes
|
Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid).
A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin.
The first needle pass will not be considered a redirection.
|
15 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Needle reinsertions
Délai: 15 minutes
|
Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace.
|
15 minutes
|
|
Need to change to another interspace.
Délai: 15 minutes
|
Relocating the spinal needle to another interspace.
|
15 minutes
|
|
Procedure time
Délai: 15 minutes
|
Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid.
|
15 minutes
|
|
Pain score
Délai: 15 minutes
|
Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable).
|
15 minutes
|
|
Intervertebral level agreement
Délai: 3 hours
|
Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation.
|
3 hours
|
|
Ultrasound Grading
Délai: 3 hours
|
Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image.
|
3 hours
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Cristian Arzola, MD, Mount Sinai Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 13-02
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