- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07625397
Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)
Imran's Approach: A Quasi-Experimental Prospective Comparative Study of an Alternative Positioning Technique for Spinal Anesthesia and Lumbar Puncture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Wah, Punjab Province, Pakistan, 4070
- Wah Medical College, POF Hospital Wah cantt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First Attempt Procedural Success
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Procedural Time
Time Frame: 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
Time Frame: During the procedure
|
Total number of skin puncture attempts required to successfully complete the procedure.
|
During the procedure
|
|
Needle Redirections
Time Frame: During the procedure
|
Number of needle redirections required during spinal anesthesia or lumbar puncture.
|
During the procedure
|
|
Intervertebral Space Changes
Time Frame: During the procedure
|
Number of intervertebral space changes required to successfully complete the procedure.
|
During the procedure
|
|
Overall Procedural Success
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WMC-IRB-157-2026
- IRB Approval Number (Other Identifier: WMC/ERC/IRB/157)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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