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

June 3, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wah Medical college , POF hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Imran Ul Haq, MBBS, FCPS, Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 1 year after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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