Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Punjab Province
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Wah, Punjab Province, Pakistán, 4070
- Wah Medical College, POF Hospital Wah cantt
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Conventional Sitting Position
Participants underwent spinal anesthesia or lumbar puncture using the conventional sitting position according to standard institutional practice.
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Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures.
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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First Attempt Procedural Success
Periodo de tiempo: During the procedure (up to 30 minutes)
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Successful spinal anesthesia or lumbar puncture achieved with a single skin puncture on the first attempt.
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During the procedure (up to 30 minutes)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Procedural Time
Periodo de tiempo: During the procedure (up to 30 minutes)
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Total time required from patient positioning to successful completion of spinal anesthesia or lumbar puncture.
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During the procedure (up to 30 minutes)
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Number of Needle Attempts
Periodo de tiempo: During the procedure
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Total number of skin puncture attempts required to successfully complete the procedure.
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During the procedure
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Needle Redirections
Periodo de tiempo: During the procedure
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Number of needle redirections required during spinal anesthesia or lumbar puncture.
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During the procedure
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Intervertebral Space Changes
Periodo de tiempo: During the procedure
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Number of intervertebral space changes required to successfully complete the procedure.
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During the procedure
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Overall Procedural Success
Periodo de tiempo: During the procedure (up to 30 minutes)
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Successful completion of spinal anesthesia or lumbar puncture regardless of the number of attempts required.
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During the procedure (up to 30 minutes)
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Patient Comfort Assessed Using a 0-10 Numeric Rating Scale (NRS)
Periodo de tiempo: During the procedure
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Participant comfort during positioning and spinal anesthesia/lumbar puncture was assessed using a 0-10 Numeric Rating Scale, where lower scores indicate greater comfort.
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During the procedure
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Ability to Maintain Position Assessed Using an Investigator-Defined 3-Category Scale
Periodo de tiempo: During the procedure
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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During the procedure
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Procedure-Related Complications
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de marzo de 2026
Finalización primaria (Actual)
31 de marzo de 2026
Finalización del estudio (Actual)
31 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- WMC-IRB-157-2026
- IRB Approval Number (Otro identificador: TMU-JIRB N202410073)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in the published article, after de-identification.
Marco de tiempo para compartir IPD
Beginning 1 year after publication
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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