Regional anesthesia, particularly spinal anesthesia, is the preferred technique for many infraumbilical surgeries, owing to its safety, cost-effectiveness, and reliable blockade of motor, sensory, and sympathetic functions depending on the dose and concentration of local anesthetic agents administered into the subarachnoid space [1-3]. Its widespread adoption is especially notable in obstetric practice, where spinal anesthesia for cesarean sections offers advantages such as reduced aspiration risk, avoidance of neonatal respiratory depression, decreased intraoperative blood loss, and extended postoperative analgesia [4]. Additionally, in obese and multimorbid patients, spinal anesthesia is favored over general anesthesia due to better safety profiles and improved outcomes [5-7]. Despite its benefits, some patients exhibit apprehension towards spinal anesthesia, citing fears related to needle insertion, neurological sequelae, back pain, or anticipated procedural discomfort [8-10]. Needle-related anxiety and fear of adverse events, including paralysis or nerve damage, can lead to patient refusal and pose challenges for anesthesiologists. Managing patient comfort and reducing procedural pain are thus critical components of optimizing spinal anesthesia administration. Techniques such as the use of local anesthetic infiltration, intravenous opioids like fentanyl, and topical anesthetic agents have been explored to mitigate pain and anxiety associated with lumbar puncture [11-20]. Among these, the application of topical anesthetic patches, such as the 5% lidocaine medicated patch, has gained attention as a non-invasive method to diminish superficial pain prior to needle insertion. The lidocaine patch provides continuous local anesthetic delivery over an extended period, potentially reducing procedural discomfort without systemic opioid-related side effects or interference with anatomical landmarks [21-24]. This study aims to evaluate the efficacy of preoperative lidocaine patch application in decreasing pain during lumbar puncture, thereby enhancing patient comfort and facilitating smoother spinal anesthesia procedures. The aim of this study is to evaluate the efficacy of a 5% w/w lidocaine medicated patch in reducing pain and enhancing patient satisfaction, as measured by the Numerical Rating Scale-11 (NRS-11), during lumbar puncture in patients undergoing elective infraumbilical surgery. The primary objectives are to assess pain levels during the procedure and to gauge patient satisfaction and their future preference for spinal anesthesia. Secondary objectives include monitoring and documenting any adverse effects related to the medicated patch, such as local skin reactions.

This prospective observational study was conducted on 100 ASA I-II patients aged 18-60 years scheduled for elective infraumbilical surgery at Nehru Hospital, B.R.D Medical College, Gorakhpur, between December 2019 and November 2020. Ethical approval was obtained, and informed consent was secured from all participants. Sample Size and Grouping A total of 100 patients were randomly divided into two groups of 50 each, with allocation concealed using randomization software to ensure 90% power, 95% confidence level, and a significance level of <0.05. - Group C (Control): Received a placebo gauze patch covered with adhesive tape 30 minutes prior to spinal anesthesia. - Group L (Lidocaine): Received a 5 cm x 7 cm 5% lidocaine medicated patch (containing 175 mg lidocaine) covered with gauze and adhesive tape 30 minutes prior. Exclusion Criteria Patients refusing consent, with contraindications to spinal anesthesia, spinal deformities, prior back surgery, local anesthetic allergy, current analgesic/opioid use, acute pain conditions, more than three needle attempts, or local infection were excluded. Preoperative Evaluation All patients underwent thorough pre-anesthetic assessment, including history, physical exam, and laboratory tests. Fasting was observed as per ASA guidelines. Patients were educated on rating pain using the Numeric Rating Scale-11 (NRS), where 0 indicates no pain and 10 the worst imaginable pain. Baseline vitals (ECG, HR, SBP, DBP, MAP, SpO2) were recorded after securing IV access and attachment of monitors. Intervention Thirty minutes before the procedure, Group C received the placebo patch, while Group L received the lidocaine patch. Both patches were applied to the lumbar region, covered with gauze and adhesive tape, and removed just before spinal anesthesia. Standard aseptic precautions were followed, and spinal anesthesia was administered with a 25G Quincke needle at the lumbar level. Outcome Measures - Primary: Pain during lumbar puncture, assessed via NRS immediately after needle insertion. - Secondary: Patient satisfaction scored as 1=very satisfied to 5=very unsatisfied, and any adverse effects such as local skin reactions. Future preference for spinal anesthesia was also recorded. Data Analysis Data were compiled and analyzed using SPSS v24.0. Quantitative data were expressed as mean ± SD and compared using independent t-tests. Categorical variables were analyzed with Chi-square tests. A p-value <0.05 was considered statistically significant.

Table No. 1: Cross table between Gender and Study Groups Characteristics Group L (n=50) Group C (n=50) Total (n=100) P-value Gender Male 31 (62%) 27 (54%) 58 (58%) 0.418 Female 19 (38%) 23 (46%) 42 (42%) Age <30 17 (34%) 17 (34%) 34 (34%) 0.053 30-45 18 (36%) 20 (40%) 38 (38%) 45-59 10 (20%) 2 (4%) 12 (12%) ≥60 5 (10%) 11 (22%) 16 (16%) Table 1 shoes that males were higher in proportion than females (p = 0.418) and a higher proportion of participants belonged to the age group 30-45 years (38%) followed by those who were less than 30 years of age (34%). (p=0.053). Table No. 2: Cross table between ASA Grade and Study Groups ASA Grade Group L (n=50) Group C (n=50) Total (n=100) I 35 (70%) 19 (38%) 54 (54%) II 15 (30%) 31 (62%) 46 (46%) Chi Square Value = 10.306; p – value = 0.001 ASA grade II was significantly higher in Group C as compared to Group L (ASA Grade II: Group L vs. Group C: 30% vs. 62%, p = 0.001). It is shown in Table No. 2. Table No. 3: Cross table between NRS Score and Study Groups NRS Group L (n=50) Group C (n=50) Total (n=100) p-value individual 1 9 (18.0%) 1 (2.0%) 10 (10%) 0.008* 2 29 (58.0%) 16 (32.0%) 45 (45.0%) 0.009* 3 11 (22.0%) 24 (48.0%) 35 (35.0%) 0.006* 4 1 (2.0%) 6 (12.0%) 7 (7.0%) 0.048* 5 0 (0.0%) 3 (6.0%) 3 (3.0%) - p – Value = 0.0001 In Group L, majority of patients – 29 (58.0%) had NRS score of 2 followed by 11 (22.0%) patients had NRS score of 3, 9 (18.0%) patients had NRS score of 1 and one (2.0%) patients had NRS score of 4. In Group C, majority of patients – 24 (48.0%) had NRS score of 3 followed by 16 (32.0%) patients had NRS score of 2, 6 (12.0%) patients had NRS score of 4, 3 patients had NRS score of 5 and one (2.0%) patients had NRS score of 1. It is shown in Table No. 3. Table No. 4: Cross table between Patient Satisfaction Score and Study Groups Patient Satisfaction Score (PSS) Group L (n=50) Group C (n=50) Total (n=100) p-value 1 45 (90.0%) 5 (10%) 50 (50.0%) 0.0001* 2 3 (6.0%) 26 (52%) 29 (29.0%) 0.0001* 3 2 (4.0%) 19 (38%) 21 (21.0%) 0.0001* p – Value = 0.0001 In Group L, 45 (90.0%) patients reported satisfaction score of 1, 3 (6.0%) patients reported satisfaction score of 2 and 2 (4.0%) patients reported satisfaction score of 3 whereas in Group C, 5 (10.0%) patients reported satisfaction score of 1, 26 (52%) patients reported satisfaction score of 2 and 19 (38%) patients reported satisfaction score of 3. It is shown in Table No. 4. Table No. 5: Comparison of mean value of Pulse Rate (Min) between study groups Pulse Rate (Min) Group L (Mean±SD) (n=50) Group C (Mean±SD) (n=50) p - value Before Procedure 83.1±9.2 84.2±14.1 0.651 During Procedure 81.5±8.9 82.5±13.8 0.687 After Procedure 80.0±9.0 80.9±13.9 0.670 * p - Value < 0.05, statistically significant There was no significant difference observed in pulse rate between the study groups at before, during and after the procedure (p > 0.05). It is shown in Table No. 5. Table No. 6: Comparison of mean value of SBP (mmHg) between study groups SBP (mmHg) Group L (Mean±SD) (n=50) Group C (Mean±SD) (n=50) p - value Before Procedure 122.7±10.8 121.9±11.6 0.696 After Procedure 121.6±8.5 123.0±8.4 0.406 DBP (mmHg) Group L (Mean±SD) (n=50) Group C (Mean±SD) (n=50) p - value Before Procedure 77.8±8.8 79.3±4.9 0.297 After Procedure 77.5±9.1 78.1±5.6 0.694 * p - Value < 0.05, statistically significant There was no significant difference observed in mean SBP (mmHg) between the study groups at before and after the procedure (p > 0.05). It is shown in Table No. 6. There was no significant difference observed in mean DBP (mmHg) between the study groups at before and after the procedure (p > 0.05). It is shown in Table No. 6. Table No. 7: Comparison of mean value of MAP (mmHg) between study groups MAP (mmHg) Group L (Mean±SD) (n=50) Group C (Mean±SD) (n=50) p - value Before Procedure 92.8±6.5 93.5±5.6 0.570 After Procedure 92.2±6.7 93.1±5.0 0.463 * p - Value < 0.05, statistically significant There was no significant difference observed in mean MAP (mmHg) between the study groups at before and after the procedure (p > 0.05). It is shown in Table No. 7. Table No. 8: Comparison of mean value of BMI (Kg/m2) between study groups DBP (mmHg) Group L (Mean±SD) (n=50) Group C (Mean±SD) (n=50) p - value Height (cm) 162.7±7.2 163.7±6.0 0.459 Weight (Kg) 62.5±9.0 66.3±6.8 0.023* BMI (Kg/m2) 23.5±2.7 24.7±2.1 0.016* * p - Value < 0.05, statistically significant There was no significant difference observed in BMI (Kg/m2) between the study groups (p > 0.05). It is shown in Table No. 8.

The lidocaine patch comprises a white hydrogel adhesive containing 700 mg of 5% lidocaine, attached to a non-woven polyethylene terephthalate backing. It blocks nerve conduction by stabilizing neuronal membranes, providing analgesia without inducing anesthesia—thus avoiding skin numbness or sensory loss [54, 55]. Studies indicate that pain relief begins within 30 minutes of application, peaking around 2 to 4 hours, with a maximum of three patches applied simultaneously for up to 12 hours, followed by a 12-hour patch-free interval [54, 56]. The systemic absorption of lidocaine from the patch is minimal, with plasma levels well below toxicity thresholds, ensuring safety while delivering effective local analgesia [57]. In our study, the lidocaine patch was cut into 5×7 cm pieces containing 175 mg lidocaine and applied 30 minutes prior to spinal puncture, then removed immediately before needle insertion to prevent cross-contamination. Demographically, both groups were comparable regarding age and gender, with no significant differences. Despite a higher proportion of ASA II patients in the lidocaine group, this did not influence outcomes. Pain scores measured via NRS demonstrated significantly lower pain in the lidocaine group (mean 2.08) compared to controls (mean 2.88), aligning with previous findings that topical lidocaine reduces procedural pain [49, 51, 53]. Patient satisfaction was markedly higher in the lidocaine group, with 90% reporting very satisfied scores, consistent with prior studies showing improved patient acceptance and reduced needle-related anxiety when using topical anesthetics like EMLA or prilocaine-lidocaine cream [25, 49, 51]. No major adverse effects were observed; minor skin erythema and itching occurred in a small subset, with no systemic complications, confirming the safety profile of the lidocaine patch [48, 49]. Hemodynamic parameters remained stable across groups, indicating that topical lidocaine does not influence systemic cardiovascular responses during spinal anesthesia. Additionally, nearly all patients in the lidocaine group expressed willingness for future spinal anesthesia, contrasting with some control patients who declined due to needle fear, underscoring the efficacy of lidocaine patch in alleviating procedural anxiety. While our findings support the utility of 5% lidocaine patches in reducing lumbar puncture pain, limitations include the subjective nature of pain assessment, limited sample size, and considerations regarding cost and availability. Nonetheless, this modality offers a simple, safe, and effective strategy to improve patient comfort during spinal anesthesia, potentially enhancing acceptance and compliance.

This study demonstrates that the 5% lidocaine patch effectively reduces spinal needle insertion pain in infraumbilical surgery, with significantly lower NRS and higher patient satisfaction compared to placebo. It is a safe, easy-to-apply alternative to other local anesthetic methods, with minimal adverse effects and a favorable patient preference for future procedures. Further research is warranted to validate these findings and establish broader clinical applications.

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