Wah Medical College, POF Hospital Wah cantt
Wah, Punjab Province, 4070, Pakistan
NCT Number: NCT07625397
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Wah, Punjab Province, 4070, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures.
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.
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.
Time frame: During the procedure (up to 30 minutes)
Total time required from patient positioning to successful completion of spinal anesthesia or lumbar puncture.
Time frame: During the procedure
Total number of skin puncture attempts required to successfully complete the procedure.
Time frame: During the procedure
Number of needle redirections required during spinal anesthesia or lumbar puncture.
Time frame: During the procedure
Number of intervertebral space changes required to successfully complete the procedure.
Time frame: During the procedure (up to 30 minutes)
Successful completion of spinal anesthesia or lumbar puncture regardless of the number of attempts required.
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.
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.
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.
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.
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.
Wah Medical college , POF hospital
Other
Imran's Approach: A Quasi-Experimental Prospective Comparative Study of an Alternative Positioning Technique for Spinal Anesthesia and Lumbar Puncture
Acronym: IMRAN-LP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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