Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)
3 juin 2026 mis à jour par: Wah Medical college , POF hospital
Imran's Approach: A Quasi-Experimental Prospective Comparative Study of an Alternative Positioning Technique for Spinal Anesthesia and Lumbar Puncture
This quasi-experimental prospective clinical trial was conducted to compare the conventional sitting position with the Imran Technique, a novel ergonomic patient-positioning method, for spinal anesthesia and lumbar puncture.
A total of 200 adult participants requiring spinal anesthesia for surgical procedures or diagnostic lumbar puncture were allocated into two groups.
The study aimed to evaluate procedural success, procedural efficiency, patient comfort, operator ergonomics, and procedure-related complications associated with the two positioning techniques.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This quasi-experimental prospective clinical trial was designed to compare the conventional sitting position and the Imran Technique during spinal anesthesia and lumbar puncture procedures. Adult participants aged 18 to 65 years who required spinal anesthesia for surgical procedures or diagnostic lumbar puncture were enrolled and allocated into two groups.
Participants in the control group underwent the procedure using the conventional sitting position, while participants in the intervention group underwent the procedure using the Imran Technique. The primary outcome measure was first-attempt procedural success. Secondary outcome measures included total procedural time, positioning-to-needle insertion time, number of needle attempts, needle redirections, intervertebral space changes, overall procedural success, need for operator assistance, patient comfort, ability to maintain position, operator strain, accessibility of the intervertebral space, and procedure-related complications.
The study was conducted at the Intensive Care Unit of the Department of Anaesthesiology, POF Hospital, Wah Cantt, Pakistan, following Institutional Review Board approval and written informed consent procedures.
Type d'étude
Interventionnel
Inscription (Réel)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Punjab Province
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Wah, Punjab Province, Pakistan, 4070
- Wah Medical College, POF Hospital Wah cantt
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Adult participants aged 18 to 65 years
- Participants requiring spinal anesthesia for surgical procedures or diagnostic lumbar puncture
- Participants medically suitable for spinal anesthesia or lumbar puncture
- Participants able to assume and maintain the assigned procedural position
- Participants who provided written informed consent
Exclusion Criteria:
- Age below 18 years or above 65 years
- Previous spinal surgery
- Significant spinal deformity
- Local infection at the puncture site
- Coagulopathy or bleeding disorders
- Raised intracranial pressure
- Severe hemodynamic instability
- Inability to maintain the assigned procedural position
- Refusal to participate or inability to provide informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Conventional Sitting Position
Participants underwent spinal anesthesia or lumbar puncture using the conventional sitting position according to standard institutional practice.
|
Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures.
|
|
Expérimental: Imran Technique
Participants underwent spinal anesthesia or lumbar puncture using the Imran Technique, a novel ergonomic positioning method designed to improve lumbar flexion, operator ergonomics, and procedural access.
|
A novel ergonomic patient positioning technique for spinal anesthesia and lumbar puncture involving lateral operator positioning and assisted lumbar flexion to improve procedural access and success.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
First Attempt Procedural Success
Délai: During the procedure (up to 30 minutes)
|
Successful spinal anesthesia or lumbar puncture achieved with a single skin puncture on the first attempt.
|
During the procedure (up to 30 minutes)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Procedural Time
Délai: During the procedure (up to 30 minutes)
|
Total time required from patient positioning to successful completion of spinal anesthesia or lumbar puncture.
|
During the procedure (up to 30 minutes)
|
|
Number of Needle Attempts
Délai: During the procedure
|
Total number of skin puncture attempts required to successfully complete the procedure.
|
During the procedure
|
|
Needle Redirections
Délai: During the procedure
|
Number of needle redirections required during spinal anesthesia or lumbar puncture.
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During the procedure
|
|
Intervertebral Space Changes
Délai: During the procedure
|
Number of intervertebral space changes required to successfully complete the procedure.
|
During the procedure
|
|
Overall Procedural Success
Délai: During the procedure (up to 30 minutes)
|
Successful completion of spinal anesthesia or lumbar puncture regardless of the number of attempts required.
|
During the procedure (up to 30 minutes)
|
|
Patient Comfort Assessed Using a 0-10 Numeric Rating Scale (NRS)
Délai: During the procedure
|
Participant comfort during positioning and spinal anesthesia/lumbar puncture was assessed using a 0-10 Numeric Rating Scale, where lower scores indicate greater comfort.
|
During the procedure
|
|
Ability to Maintain Position Assessed Using an Investigator-Defined 3-Category Scale
Délai: During the procedure
|
Participant ability to maintain the assigned procedural position was assessed using an investigator-defined 3-category scale: Easy, Moderate, or Difficult.
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During the procedure
|
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Operator Strain Assessed Using an Investigator-Defined 4-Category Ergonomic Scale
Délai: During the procedure
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Operator physical strain during the procedure was assessed using an investigator-defined 4-category scale: None, Mild, Moderate, or Severe.
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During the procedure
|
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Accessibility of Intervertebral Space Assessed Using an Investigator-Defined 3-Category Operator Rating Scale
Délai: During the procedure
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Accessibility of the intervertebral space was assessed by the operator using an investigator-defined 3-category scale: Easy, Acceptable, or Difficult.
|
During the procedure
|
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Procedure-Related Complications
Délai: uring the procedure and immediately after procedure (up to 1 hour)
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Occurrence of procedure-related events including paresthesia, bloody tap, hypotension, bradycardia, or procedural failure.
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uring the procedure and immediately after procedure (up to 1 hour)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 mars 2026
Achèvement primaire (Réel)
31 mars 2026
Achèvement de l'étude (Réel)
31 mars 2026
Dates d'inscription aux études
Première soumission
27 mai 2026
Première soumission répondant aux critères de contrôle qualité
3 juin 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- WMC-IRB-157-2026
- IRB Approval Number (Autre identifiant: TMU-JIRB N202410073)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data that underlie the results reported in the published article, after de-identification.
Délai de partage IPD
Beginning 1 year after publication
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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