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Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Punjab Province
      • Wah, Punjab Province, Pakistan, 4070
        • Wah Medical College, POF Hospital Wah cantt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional Sitting Position
Participants underwent spinal anesthesia or lumbar puncture using the conventional sitting position according to standard institutional practice.
Procedure: Conventional Sitting Position
Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures.
Eksperimentel: 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.
Procedure: Imran Technique
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
First Attempt Procedural Success
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Procedural Time
Tidsramme: 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
Tidsramme: During the procedure
Total number of skin puncture attempts required to successfully complete the procedure.
During the procedure
Needle Redirections
Tidsramme: During the procedure
Number of needle redirections required during spinal anesthesia or lumbar puncture.
During the procedure
Intervertebral Space Changes
Tidsramme: During the procedure
Number of intervertebral space changes required to successfully complete the procedure.
During the procedure
Overall Procedural Success
Tidsramme: 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)
Tidsramme: 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
Tidsramme: During the procedure
Participant ability to maintain the assigned procedural position was assessed using an investigator-defined 3-category scale: Easy, Moderate, or Difficult.
During the procedure
Operator Strain Assessed Using an Investigator-Defined 4-Category Ergonomic Scale
Tidsramme: During the procedure
Operator physical strain during the procedure was assessed using an investigator-defined 4-category scale: None, Mild, Moderate, or Severe.
During the procedure
Accessibility of Intervertebral Space Assessed Using an Investigator-Defined 3-Category Operator Rating Scale
Tidsramme: During the procedure
Accessibility of the intervertebral space was assessed by the operator using an investigator-defined 3-category scale: Easy, Acceptable, or Difficult.
During the procedure
Procedure-Related Complications
Tidsramme: uring the procedure and immediately after procedure (up to 1 hour)
Occurrence of procedure-related events including paresthesia, bloody tap, hypotension, bradycardia, or procedural failure.
uring the procedure and immediately after procedure (up to 1 hour)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wah Medical college , POF hospital

Efterforskere

  • Ledende efterforsker: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. marts 2026

Primær færdiggørelse (Faktiske)

31. marts 2026

Studieafslutning (Faktiske)

31. marts 2026

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • WMC-IRB-157-2026
  • IRB Approval Number (Anden identifikator: WMC/ERC/IRB/157)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported in the published article, after de-identification.

IPD-delingstidsramme

Beginning 1 year after publication

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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