Maternal satisfaction with anesthesia services in the perioperative period is a critical indicator of the quality of care that every pregnant patient deserves [1]. Merely administering a subarachnoid block or general anesthesia does not guarantee the satisfaction of the patient or empower her to approach the subsequent pregnancies with enthusiasm. Factors such as paresthesia, multiple needle pricks for anesthesia, needle prick pain, unsuccessful subarachnoid blockade or inadequate analgesia, intraoperative nausea, vomiting, shivering, and headache are cited as the common causes of maternal discontent [2,3].

About 10-20% of pregnant patients who undergo lower segment cesarean delivery experience fear associated with spinal needle pricks and their potential negative consequences [4,5]. This causes apprehension in the patient, resulting in non-cooperation or refusal during the administration of subarachnoid blockade. Furthermore, the patient can react strongly to even minimal touch sensation at the needle puncture site. Researchers have explored several methods to alleviate the fear associated with spinal needles. These include the eutectic mixture of local anesthetic (EMLA) patch, ethyl chloride vapocoolant spray, subcutaneous lidocaine infiltration, and the shot blocker device [6-9]. However, the protocol for standard anesthesia practice has not advocated any of these techniques. The reasons may include non-availability within the operating theatre (vapocoolant spray/shot-blocker device), slow onset of action (EMLA cream), uncertainty of action (non-pharmacological interventions), or invasive mode of administration (lidocaine 2% infiltration).

Topical 10% lidocaine spray, easily available in the operating room, provides several advantages, including a quick onset, a painless application, and low cost, and may serve as an appropriate intervention to allay this spinal needle fear. The physicochemical characteristics of lidocaine enable swift penetration of lipid membranes and prompt initiation of cutaneous anesthesia upon access to sub-epidermal nerve terminals. The dermal administration of high concentrations of lidocaine (8-10%) is safe, with serum levels remaining low even when applied to compromised skin [10,11].

No studies to date have used 10% lidocaine spray to alleviate needle prick pain and associated discomfort for subarachnoid block administration in the pregnant patient. Considering the physiochemical properties of the 10% lidocaine spray, we hypothesized that it can improve maternal satisfaction for anesthesia services by decreasing needle-associated discomfort. The primary objective was to evaluate maternal satisfaction with anesthesia services at the end of surgery using a 5-point Likert scale. The secondary objectives included comparing pain during spinal needle insertion using the numeric rating scale (NRS) score and physical response to pain and examining if pain during puncture affected the choice regarding spinal anesthesia.

We conducted a single-center, double-blind, prospective, randomized control study after Institutional Ethics Committee of Indira Gandhi Institute of Medical Sciences, approval (1373/IEC/IGIMS/2024) and registration at the Clinical Trials Registry-India (https://ctri.nic.in/; registration number: CTRI/2024/04/065761, registered on 16th April, 2024) between May 2024 and November 2024 at a tertiary care center in India. This study was carried out following the principles of the Declaration of Helsinki, and good clinical practice guidelines. Informed written consent was taken from all patients prior to enrollment in the study. This study was conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

The CONSORT diagram (Fig. 1) depicts the selection, randomization, intervention, and analysis of the study group. Out of 115 patients assessed for eligibility, 110 patients were randomized and data from 99 patients was analyzed. The demographic data showed no significant difference between the two groups (Table 1).

A Mann-Whitney U test revealed no significant difference in MSS between the two groups (P = 0.767), demonstrating a similar mean rank satisfaction score in the LIDO group (50.76) (median [1Q, 3Q]: 4 [4, 5]) compared to the NS group (49.26) (median [1Q, 3Q]: 4 [4, 5]), as seen in Fig. 2. In the LIDO group, 49% of the parturient reported maternal satisfaction as very satisfied (score 5), and the rest, 51%, reported it as satisfied (score 4). Similarly, in the NS group, 48% of the parturient were very satisfied and another 48% were satisfied, while the remaining 4% were neutral (score 3).

The mean rank NRS score for the spinal needle prick in group NS was 73.22 (median [1Q, 3Q]: 5 [5, 6]), and in group LIDO it was 26.31 (median [1Q, 3Q]: 3 [3, 5]), which was statistically significant (P < 0.001) (Fig. 3).

There was a significant difference in the physical response to spinal needle prick pain between the two groups (P < 0.001). The mean rank physical response to a spinal needle prick was 38.50 (median [1Q, 3Q]: 0 [1, 1]) in the LIDO group, compared to 61.27 (median [1Q, 3Q]: 2 [1, 3]) in the NS group. There was a significant difference in the average number of spinal needle pricks required to achieve free flow of cerebrospinal fluid between the two groups (median [1Q, 3Q]: 1 [1, 1] in Group LIDO, 1 [1, 2] in Group NS) (P < 0.045).

There were no adverse effects seen due to the application of 10% lidocaine at the time of discharge. Only 4% and 6% of patients in groups LIDO and NS, respectively, experienced backaches until the time of discharge. Of the 99 patients studied, 10 patients (5 in each group) complained of post dural puncture headache during their stay in the hospital. Most patients (91.8%) in group LIDO and 90% in group NS said that they would choose regional anesthesia over general anesthesia for further procedures.

We studied the correlation between maternal satisfaction and the effect of the intervention (physical response to spinal needle prick pain, number of attempts to achieve free flow of CSF, and NRS score to spinal needle prick pain). A moderately negative correlation was found between maternal satisfaction and her body’s response to spinal needle prick pain (rs = -0.610, 95% CI -0.383 to -0.754, P < 0.001) in both the LIDO group and the NS group (rs = -0.716, 95% CI -0.495 to -0.805, P < 0.001) (Fig. 4). However, no statistically significant correlation was observed between maternal satisfaction and NRS score or number of pricks (Supplementary file). Other correlations, such as between NRS and number of pricks, are presented in the Supplementary Tables 1, 2.

In the present study, we analyzed the effect of a topical spray of 10% lidocaine given prior to a spinal needle prick on maternal satisfaction, pain, and physical discomfort. We found similar maternal satisfaction in patients who received 10% LIDO spray or placebo; however, there was a significantly lower NRS score and physical response to needle prick in the 10% LIDO group. We endeavored to establish a correlation between maternal satisfaction and the various factors (physical response to pain, number of pricks, and NRS) influenced by our intervention. We found a statistically significant, moderate negative correlation between maternal satisfaction and physical response to spinal needle prick pain. However, we found no statistically significant correlation between the maternal satisfaction and NRS score or number of pricks. In order to achieve better maternal satisfaction and ensure smooth recovery post-spinal anesthesia, it is imperative to target the modifiable anesthesia-related issues. Prior studies have reported inconsistent findings on whether spinal prick pain serves as an independent determinant of maternal satisfaction [12-14]. In our study, despite addressing spinal needle prick pain, maternal satisfaction in the LIDO group was found comparable to the control group. In our patient population, we were unable to establish spinal prick pain as an independent predictor of maternal satisfaction; therefore, addressing it was insufficient to achieve a remarkable difference in maternal satisfaction. This finding is similar to the results of other studies evaluating maternal satisfaction [15,16].

Contrary to our findings, recent trials have demonstrated improved maternal satisfaction in similar patient populations with EMLA cream as compared to lidocaine infiltration and Shotblocker with vapocoolant spray [9,17]. They assessed the maternal satisfaction immediately after administering the subarachnoid blockade, which incorporates the overall experience of the anesthesia procedure only. On the other hand, we assessed the maternal satisfaction after the end of surgery, with the intention of assessing maternal satisfaction with the overall anesthesia services. This further guided us to understand the significance of spinal needle prick pain in anesthesia services.

Spinal anesthesia is the preferred technique for cesarean delivery so that the mother can witness the birth of her baby and breastfeed as early as possible. Most pregnant patients declining spinal anesthesia (20%) state fear of needle prick pain as one of the most common reasons for refusal [18]. Other factors such as intraoperative pain have been found to be independent predictors of maternal dissatisfaction; however, puncture attempts more than 2, postoperative nausea and vomiting, and post-dural puncture headache were not found to be predictors of maternal dissatisfaction [19]. In our study, the majority of patients only needed a single prick for spinal anesthesia, and there was no instance of an insufficient or unsuccessful blockade. A small percentage of patients required motivation since they were extremely fearful of needle pain. These factors ensured satisfaction scores of 4 or 5 in most of the patients of both study groups. We believe that the quality of care should be improved to the highest possible level to ensure that the pregnant patient does not have any fear in successive exposures. 10% lidocaine spray has been successful in addressing needle prick pain in other patient profiles. A study that assessed the effect of 10% lidocaine spray for peripheral venous cannulation to relieve pain in children found that it was equally effective as an EMLA cream [20]. Another study demonstrated that a 10% lidocaine spray resulted in a lower NRS score compared to placebo for a reduction in pain on venipuncture in pregnant patients posted for cesarean delivery (P value = 0.001) [21]. Lidocaine 10% spray was also better at relieving pain during radial artery blood gas sampling (P < 0.001) compared to a placebo. The lidocaine group had a significantly lower VAS score for radial arterial puncture pain compared to the placebo group (P value = 0.011) [22,23]. All these studies evaluated the effect of lidocaine spray in relatively superficial procedures.

The pain during spinal needle insertion decreases patient cooperation during the procedure, thereby negatively influencing the efficiency of the anesthesiologist. Therefore, many studies have evaluated non-pharmacological and pharmacological methods to alleviate the fear and subsequent pain of spinal needle pricks. The interventions like the EMLA patch, ethyl chloride vapocoolant spray, and subcutaneous lidocaine infiltration acting on skin and subcutaneous tissue have been found effective in both alleviating pain due to spinal needle prick and improving maternal satisfaction. Therefore, we hypothesized that lidocaine spray could be equally effective, with a faster onset and without a prick in itself. We conducted a placebo-controlled trial first in order to demonstrate the effects of 10% lidocaine spray on spinal needle prick pain and maternal satisfaction. Ghalenoii et al. [24] conducted a single-blind randomized clinical trial in 263 parturient to assess patient satisfaction when using 10% lidocaine spray or EMLA cream with placebo before subarachnoid blockade in caesarean section. They found no significant difference in pain score, but satisfaction was significantly higher with 10% lidocaine spray. These results are contradictory to our findings, as we observed lower pain scores for spinal needle prick with lidocaine spray but comparable maternal satisfaction in both groups. This difference can be due to non-standardization of anesthesia technique, a lack of objective measures of physiological responses, and a small sample size. Our study encompasses most of the suggestions for future trials by them.

Despite clear indications for the interventions to reduce spinal needle prick pain in routine practice, no recommendations are available for the anesthesiologists. This knowledge gap must be addressed through suitable clinical interventions, underpinned by rigorously designed and authentically executed research, accompanied by statistical data demonstrating its efficacy.

Our methodology differed from other studies since we chose maternal satisfaction at the end of surgery in order to assess all the potential effects of our intervention in pregnant patients. We decided on the method of drug delivery (number of puffs, distance from skin, and waiting time before prick) on the basis of existing literature and our pilot study to achieve maximal effect in the least time [7,21]. Along with the pain score (subjective), we also assessed the physical response of the patient (objective) for a more comprehensive assessment of pain. In our opinion, both these assessments are equally important since pregnant women reporting higher pain scores might require more analgesics and interventions.

The limitations of our study are that it is a single-center study with a limited sample size. Maternal satisfaction is a dynamic variable, being influenced by various patient-related, service-related, and circumstantial factors. Our intervention addressed a single factor; therefore, we could not consider the final choice of patient at the time of discharge. Our control group was placebo, since we wanted to observe the effects of lidocaine spray over spinal needle prick pain. Further studies can be conducted comparing lidocaine spray and other studied interventions or newer methods in pregnant patients, considering our results and multiple factors influencing maternal satisfaction. Also, improved cooperation of the parturient, time of block performance, and reduced anesthesiologist workload must also be evaluated in further studies.

Topical 10% lidocaine spray is a feasible, economic, and effective intervention to alleviate pain during spinal needle pricks in pregnant women. However, our findings also indicate that the reduction in prick pain did not translate into improved maternal satisfaction, highlighting that the clinical significance of this intervention is limited. Maternal satisfaction is a multidimensional concept, and future strategies should address multiple factors beyond needle prick pain to provide quality anesthesia services.