Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)
3 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
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Wah, Punjab Province, Pakistan, 4070
- Wah Medical College, POF Hospital Wah cantt
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
First Attempt Procedural Success
Tidsram: During the procedure (up to 30 minutes)
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Procedural Time
Tidsram: During the procedure (up to 30 minutes)
|
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)
|
|
Number of Needle Attempts
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
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Ability to Maintain Position Assessed Using an Investigator-Defined 3-Category Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 mars 2026
Primärt slutförande (Faktisk)
31 mars 2026
Avslutad studie (Faktisk)
31 mars 2026
Studieregistreringsdatum
Först inskickad
27 maj 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- WMC-IRB-157-2026
- IRB Approval Number (Annan identifierare: TMU-JIRB N202410073)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie the results reported in the published article, after de-identification.
Tidsram för IPD-delning
Beginning 1 year after publication
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
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Nej
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