Role of 5 percent Lignocaine Patch in Reducing Pain and Improving Patient Satisfaction During SpinalAnesthesia – An Observational Study

Spinal anesthesia is one of the most commonly performed regional anesthetic techniques worldwide, especially for lower abdominal, pelvic, and lower limb surgeries. It offers numerous advantages, including rapid onset of anesthesia, profound sensory and motor block, avoidance of airway instrumentation, reduced blood loss, and early postoperative recovery. Despite these benefits, patients often experience discomfort or pain during the procedure, particularly at the time of spinal needle insertion. This moment of pain can heighten anxiety, reduce cooperation, and negatively affect the overall patient experience with anaesthesia. In the context of spinal anaesthesia, pre-application of a 5% lignocaine patch over the proposed lumbar puncture site offers several potential advantages: Non-invasive dermal anaesthesia without additional injections, Reduced pain perception during spinal needle insertion, Increased patient comfort and satisfaction, which may enhance overall perioperative experience, Ease of application and time efficiency for anaesthesiology staff. This study has therefore been designed as a prospective observational study to document the pain experienced during spinal needle insertion and the overall satisfaction of patients after pre-procedure application of a 5% lignocaine patch. The findings will help clarify whether this simple intervention can improve patient comfort and inform larger comparative or randomized studies in the future.  The study population will consist of adult patients scheduled to undergo elective surgical procedures under spinal anesthesia at the Department of Anesthesiology and Critical Care, Dr Balasaheb Vikhe Patil Rural Medical College. All participants will receive a 5% lignocaine patch at the proposed lumbar puncture site before the spinal anesthesia procedure. Eligible patients will be screened and consented one day before surgery.

On the day of surgery, demographic details and relevant medical history will be recorded on a pre-designed case record form (CRF).

Data Collection

1. Recruitment and ConsentAll adult patients scheduled for elective lower abdominal or lower limb surgery under spinal anaesthesia in the Department of Anaesthesiology will be screened for eligibility. After verifying inclusion and exclusion criteria, eligible patients will be approached one day prior to surgery. Written informed consent will be obtained in their preferred language after explaining the nature and purpose of the study, potential risks, and benefits.

2. Application of 5% Lignocaine PatchA 5% lignocaine patch will be applied at the intended lumbar puncture site approximately 60 minutes prior to the procedure, as per manufacturer’s instructions. Time of application and removal will be documented.

3. Spinal Anaesthesia Procedure DataDuring spinal anaesthesia, the following procedural details will be recorded:• Level of spinal needle insertion (L3–L4 or L4–L5)• Needle size and type used• Number of attempts at lumbar puncture• Duration between patch removal and spinal needle insertion• Any adverse reactions (local skin reactions, systemic effects)

4. Pain MeasurementImmediately after spinal needle insertion, the patient will be asked to rate the pain using a 10-cm Visual Analogue Scale (VAS) where 0 represents no pain and 10 represents the worst possible pain. This VAS score will be recorded in the CRF.

5. Patient SatisfactionWithin 30–60 minutes postoperatively, patients will be asked to rate their satisfaction with the procedure using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied). This will also be recorded.

6. Safety MonitoringAny adverse events, allergic reactions, or unexpected side effects during or after the patch application and spinal anaesthesia will be documented. Appropriate medical management will be provided if necessary.

7. Data Entry and StorageAll collected data will be entered into a secure, password-protected electronic database by trained research personnel. Paper CRFs will be stored in locked cabinets accessible only to the investigators. Data confidentiality will be maintained throughout the study.

8. Data Quality AssuranceRegular cross-checking of entries between CRFs and the electronic database will be conducted to ensure accuracy and completeness. Any missing or inconsistent data will be verified with the source documents.

Aims and Objectives

1. To assess pain experienced by patients during spinal needle insertion after application of 5% lignocaine patch.

2. To evaluate patient satisfaction with the procedure.

Material and Methods

Study Type:Observational

Study Design: Cross-sectional

Setting: Department of Anesthesiology and Critical Care ,Dr Balasaheb Vikhe Patil Rural Medical College

Methodology

1. A 5% lignocaine patch will be applied at the intended lumbar puncture site approximately 60 minutes before the spinal procedure according to the manufacturer’s guidelines. 2.During spinal anaesthesia, the level of needle insertion, needle type, and number of attempts will be recorded. Immediately after needle insertion, pain will be assessed using a     10-cm Visual Analogue Scale (VAS).

3.Within 30–60 minutes post-procedure, patient satisfaction will be assessed using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).

4. Any adverse events related to the patch or the procedure will be documented.

5. Data will be collected using standardized CRFs. Baseline demographics, intraoperative parameters, VAS pain scores, satisfaction scores, and any adverse events will be entered into a secure password-protected electronic database. Confidentiality will be maintained.

6.Primary outcome: VAS pain score during spinal needle insertion after application of 5% lignocaine patch.

7. Secondary outcome: Patient satisfaction score after the procedure.

8. Safety outcome: Incidence of local or systemic adverse effects from the patch.