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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Approval Number | Other Identifier | WMC/ERC/IRB/157 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Sitting Position | Active Comparator | Participants underwent spinal anesthesia or lumbar puncture using the conventional sitting position according to standard institutional practice. |
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| Imran Technique | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Sitting Position | Procedure | Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| First Attempt Procedural Success | Successful spinal anesthesia or lumbar puncture achieved with a single skin puncture on the first attempt. | During the procedure (up to 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedural Time | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran Ul Haq, MBBS, FCPS | Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wah Medical College, POF Hospital Wah cantt | Wah | Punjab Province | 4070 | Pakistan |
Individual participant data that underlie the results reported in the published article, after de-identification.
Beginning 1 year after publication
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Participants were allocated into two parallel groups to compare the conventional sitting position with the Imran Technique for spinal anesthesia and lumbar puncture.
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| Imran Technique | Procedure | 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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Total number of skin puncture attempts required to successfully complete the procedure.
| During the procedure |
| Needle Redirections | Number of needle redirections required during spinal anesthesia or lumbar puncture. | During the procedure |
| Intervertebral Space Changes | Number of intervertebral space changes required to successfully complete the procedure. | During the procedure |
| Overall Procedural Success | 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) | 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 | 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 | 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 | 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 | 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) |