European Journal of Cardiovascular Medicine

Day care surgery or outpatient surgeries are a modern approach to surgery where the patient is admitted, operated and discharged on the same day [1]. It usually involves minimally invasive procedures which does not involve an overnight stay at the hospital. There are many advantages of day care surgeries, such as, reduced time of exposure in hospitals, decreased risk of nosocomial infections, shorter duration of recovery and lower costs of treatment which makes it convenient for the patients and their families. Spinal anaesthesia is a commonly used technique of anaesthesia for lower limb and infraumbilical surgeries. When compared with general anaesthesia, it has many advantages like it achieves adequate surgical anaesthesia with preservation of patient consciousness, simplicity and ease of performance, less blood loss, cost effectiveness and less complications [2].       

Initially, day care surgeries used intrathecal lignocaine as it has faster onset and shorter duration of action. But it was abandoned due to the development of transient neurological symptoms (TNS) causing dysesthesia or pain in buttocks or legs [3]. The other option is small dose of hyperbaric bupivacaine; but such small doses can be often inadequate. Bupivacaine also has longer duration of action and urinary retention as adverse effect which can delay the discharge of patients of outpatient surgeries [4]. Using 2-chloroprocaine (2-CP), an ester local anaesthetic, having very short half-life due to rapid metabolism by plasma pseudocholinesterase, is an attractive alternative for spinal anaesthesia in day care procedures [5]. Some of the advantages include, no requirement of adjuvants or sedation, decreased requirement of postoperative analgesics, reduced rate of nausea and vomiting during recovery and less urinary retention [6]. This makes it suitable for day care surgeries for ambulatory patients. There is a dearth of studies using 2-CP for day care surgeries in our setting. Hence, this study was planned to evaluate the effectiveness of 2-CP for spinal anaesthesia in day care surgeries.  

The duration of anaesthesia with different doses of 2-CP are variable. Many studies have been published with different doses of 1% 2-CP in spinal anaesthesia [7, 8]. 30 mg is the minimum effective dose for the same. Hence, in this study, a fixed dose of 40 mg of 1% 2-CP was used for day care surgeries. Also, to maintain the uniformity of results, the cases of unilateral tunica vaginalis hydrocele (TVH) undergoing day care surgery were included in the study.

This was a prospective, observational study conducted for a duration of one year at the department of anaesthesia after obtaining institutional ethics committee approval.

Inclusion criteria:

• Adult male patients aged 18 to 60 years admitted for unilateral TVH day care surgery under spinal anaesthesia.
• Patients with American Society of Anaesthesiologists (ASA) physical status I, II and III willing to give written informed consent for participation in the study.

Exclusion criteria:

• Patients with contraindication to spinal anaesthesia or patients with systemic illnesses like respiratory, cardiovascular and cerebral diseases.
• Patients with allergy to local anaesthetics or PABA group of drugs (as metabolite of 2-CP can cause flu like symptoms malaise, myalgias, arthralgia, fever).

Procedure:

Pre-anaesthetic check up was conducted one day prior. The procedure was explained to patients and informed consent was obtained. On the day of surgery, baseline vitals were noted in preoperative room. An intravenous (IV) line was secured and ringer lactate (RL) slow infusion started. Midazolam 1 mg was also given to the patients. After the initial preparation, patient was taken to operation theatre and the baseline vitals were again recorded by attaching the pulse oximetry, electrocardiogram and non-invasive blood pressure monitors. Spinal anaesthesia was given in sitting position using all aseptic precautions in L2-L3 or L3-L4 space with 25G spinal needle with bevel facing laterally using 40 mg of 1% 2-CP (NEON pharmaceuticals). Immediately following the injection, patient was made to lie down. After spinal block was attained, heart rate (HR), systolic and diastolic blood pressures (SBP, DBP) and partial pressure of oxygen (spO₂) were regularly monitored during the procedure. Pinprick method was used bilaterally along the midclavicular line to assess sensory block and Modified Bromage scale was used to assess motor block.

Sensory and motor effects were checked every 3 minutes up to 15minutes, till T10 level was achieved. In case T10 sensory level was not achieved within 15 mins of administering spinal anaesthesia, it was regarded as failed case and patient was given general anaesthesia.  If sensory level of T10 achieved and patient complained of pain or discomfort, then fentanyl injection 1microgram/kg was given. It was repeated for a second dose after 10 mins if the pain was persistent after first dose. If the pain was still not relieved, then it was considered as failed case, and general anaesthesia was given to the patient.

Assessments conducted:

Table 1 lists the details of sensory and motor blocks achieved with 40 mg 1% 2-CP.

Post operative care and discharge:

All patients received 100 mg diclofenac suppository after completion of surgery for post operative analgesia. Hemodynamic parameters of the patients were monitored at regular intervals during the recovery period after shifting them to recovery room. Sensory and motor effects were checked every 15 mins till complete regression. Time of ability to walk, time of ability to void and oral intake of sips of water were noted. Time to discharge home readiness was evaluated according to post anaesthesia discharge scoring system (PADSS) which was noted every half hourly up to 2 hours and then hourly till discharge of the patient. Patients were discharged if PADSS score was ≥ 9. All patients were observed for side-effects during recovery.

Statistical analysis:

The data was entered into a database Microsoft Excel sheet. The results were expressed as mean ± standard deviation. The statistical analysis was done using EPI software version 2.3 using the unpaired student t test. The difference was considered to be statistically significant when P value < 0.05 and highly significant when P value < 0.001. To generate graphs and tables, Microsoft Office 2010 (Word and Excel) has been used

The present study was conducted on 60 male patients who were scheduled for Jaboulay’s eversion for TVH. Patients were given spinal anaesthesia with injection 2-CP (1%) 40 mg intrathecally. Out of the 60 patients, 4 patients had no effect of drug when given in spinal anaesthesia and general anaesthesia was administered to them according to institutional protocol. So, data of 56 patients was considered for analysis.

Table 1. Assessments of sensory and motor block with 40 mg 1% 2-CP

Table 2 depicts the demographic data of the study population. All patients were aged between 20-60 years. Mean of patient’s age was 35.36 ± 10.71 years. Average weight of the patients was 60.8 ± 10.22 kg. Out of 56 patients, majority (67.86%) of the patients belonged to ASA class II.

Table 2: Demographic data

Assessment of sensory block

In half of the patients (51.76%, n = 29), T10 sensory level was achieved at 9 minutes after giving spinal anaesthesia; in 24 patients T10 level achieved at 6 minutes and in 2 patients T10 level achieved at 3 minutes while only in one patient T10 level was achieved at 12 minutes.

In 57.1% patients (n = 32) highest sensory level was achieved at T8 level; and in 41.1% patients T10 was the highest sensory level achieved while in 1.8% (n = 1) highest sensory level achieved by drug was T6. Time to achieve highest sensory level was 9 minutes after giving spinal anaesthesia in 34 patients; 12 minutes in 13 patients; 6 minutes in 7 patients and 15 minutes in 2 patients which shows that in only 26.8% cases it took more than 10 minutes to achieve highest sensory level. Mean duration of achieving highest sensory level was 9.54 ± 2.07 minutes.

Time for sensory block regression to L1 level was 60 minutes in 37.5% cases, 75 minutes in 25% cases and 80 minutes in 10.7% cases. So, in 51.8% cases it took only one hour for sensory level to regress at L1 level while in 75 minutes 82.2% cases showed regression to L1 level. Mean time for regression to L1 level was 65.91 ± 13.98 minutes.

Total duration of sensory blockade (also called time for total regression of sensory block) was minimum 50 minutes while maximum was 105 minutes. In maximum number of cases (91%, n = 51) total duration was between 60-99 minutes. 6 patients showed total regression of sensory effect in 60-69 minutes, 12 patients showed in 70-79 minutes, 17 patients showed in 80-89 minutes, 16 patients showed in 90-99 minutes. Mean duration of sensory block was 81.51 ± 11.71 minutes.

Table 3 summarises the characteristics of sensory block achieved with 40 mg of 1% 2-CP.

Table 3: Characteristics of sensory blockade

Assessment of motor block

Majority of the patients (71.4%, n = 40) achieved Bromage grade 1 motor block within 2 mins of injection. And within 3 minutes all patients achieved Bromage grade 1.

Maximum patients (96.4%, n = 54) achieved maximum motor block of bromage grade 3. In only 2 patients maximum motor block was grade 2. Time for achievement of maximum motor block was within 9 minutes in most of cases (80.36%, n = 45). In 22 cases, within 6 minutes maximum motor block was achieved, within 9 minutes in 23 cases; within 12 minutes in 6 cases and within 15 minutes in 5 cases maximum motor block was achieved. All patients had maximum motor effect within 15 minutes. Mean time for achieving maximum motor block was 8.68 ± 2.78 minutes.

As listed in table 4, total duration of motor block noted was minimum 70 minutes to maximum 110 minutes. Mean duration of motor block was 88.48 ± 10.83 minutes. In 87.5% cases total duration of motor block was less than 100 minutes. While 12.5% cases had motor effect for more than 100 minutes. All patients showed regression of total motor block within 2 hours of giving spinal anaesthesia with 2-CP.

Table 4: Characteristics of motor block

Duration of surgery

As depicted in figure 1, total duration of surgery was minimum 30 min to maximum 90 min. Mean duration was 53.30 ± 12.93 min.

Figure 1. Time for completion of surgery

Post operative recovery

Time of ability to walk and void was considered from the time on which spinal anaesthesia was given to the patient. 78.6% of patients (n = 44) were able to walk and void within 100 minutes of giving spinal anaesthesia. Rest 21.5% patients were able to walk and void maximum in 120 minutes of giving spinal anaesthesia. Mean duration for ability to walk and void was 90.09 ± 11.62 minutes.

62.5% (n = 35) patients achieved PADSS score ≥ 9 after 60 minutes of completion of surgery itself. So, all patients observed were ready to discharge within 60 minutes of completion of surgery as they achieved PADSS score ≥ 9. Mean duration for achieving PADSS score ≥ 9 was 48.75 ± 14.65 minutes.

Time to discharge readiness was calculated from time of giving spinal anaesthesia to time when patient was able to walk and void independently. Time to discharge readiness was minimum 75 minutes to maximum 135 minutes. As depicted in figure 2, 93% patients (n = 52) were ready to discharge within 125 minutes of giving spinal anaesthesia. 12.5% patients were ready to discharge within 85 minutes of giving spinal anaesthesia while 7.1% patients were ready for discharge within 125-145 minutes of giving spinal anaesthesia. Average time to discharge readiness was 102.05 ± 16.5 minutes.

Figure 2. Time to discharge readiness

Adverse events

Only one patient had postoperative vomiting which was treated by injection Ondansetron 4mg IV. One patient complained of mild pain post operatively which was treated with injection Diclofenac 75mg IV.

Hemodynamic parameters

Pulse

Mean of pulse at baseline was 76.19 ± 12.79 beats per minute (bpm) and at 75 minutes it was 71.84 ± 9.95 bpm (P < 0.05), shown in figure 3. There was statistically significant difference between mean pulse rate at 45, 60, 75 minutes after giving spinal anaesthesia, but clinically it was not significant.

Blood pressure

As shown in figure 4, average SBP at baseline was 120.55 ± 12.99 mm of Hg and at 75 minutes it was 116.14 ± 9.31 mm of Hg. Mean of mean arterial pressure (MAP) at baseline and 75 minutes was 91.71 ± 9.01 mm of Hg and 88.39 ± 6.65 mm of Hg (P value < 0.05). So, SBP and MAP showed statistically significant difference at 30, 45, 60 and 75 minutes when compared to baseline but clinically it was not significant as it was within ± 20% of baseline. Mean diastolic BP at baseline and at 75 minutes was 78.18 ± 7.78mm of Hg and 74.41 ± 7.41 mm of Hg. DBP showed statistically significant readings at 15, 30, 45, 60 and 75 minutes when compared to baseline readings but was not clinically significant.

Figure 3. Mean pulse rate at various time intervals

Figure 4. Average of mean arterial pressure at various time intervals

Day care surgery has become very popular now-a-days as the patient is discharged the same day after surgery. This ultimately reduces financial and logistic burden on the patients as well as healthcare system, especially in a country like India, which has a huge population and limited hospital beds. Patients undergoing regional anaesthesia have better pain relief than with general anaesthesia. Longer acting local anaesthetic agents like low dose bupivacaine prolongs time for independent ambulation and thereby delay discharge readiness. newer short acting agents like prilocaine, 2-CP has overcome this disadvantage of bupivacaine [4]. Short duration variable with the dose variation and absence of transient neurological symptoms makes 2-CP a good choice for short duration general and orthopaedic surgical procedures of lower extremities. Arrival of this agent in India by NEON pharmaceuticals prompted the research on the efficacy of this agent in spinal anaesthesia. Thus, this study was conducted to evaluate the effectiveness of 40 mg of 1% 2-CP in unilateral TVH done under spinal anaesthesia.

In the present study, majority of the patients belonged to 20 to 60 years of age and ASA class II. This is similar to the findings observed in the previous studies [9, 10]. These studies also had patients in the similar age group and ASA class I-III.

In the patients posted for TVH surgery, a minimum sensory level of T10 is required for starting the surgery. In the present study, the average duration of achievement of sensory level at T10 was 7.55 ± 1.81 minutes. This is similar to the findings of other studies [11-13]. In the study by Agarwal et al (2019), mean duration for achievement of T10 sensory level was 6 ± 2 minutes. The study by Casati et al (2006) observed that the median time required to achieve readiness to surgery was 8 (3-25) min with 30 mg, 7 (3-26) min with 40 mg and 6 (3-20) min with 50 mg dose of 2-CP. Thus, onset time was clinically early in higher dose group, but it was statistically similar in all three groups. In contrast to this, some studies reported faster achievement of T10 as compared to the present study [14, 15]. In the study by Nivas et al. (2019), the average duration of onset of sensory block was 3.85 ± 1.06 minutes with 2-CP while 4.17 ± 1.12 minutes with lidocaine and 4.2 ± 1.3 minutes with bupivacaine group. Similarly, in the study by Wesselink et al. (2019), T10 was achieved at 2 minutes with 2-CP and at 4 minutes with bupivacaine.

The highest sensory level achieved in the present study was T8. This is similar to the findings of study by Nivas et al. (2019) which reported peak sensory level between T5-T9 dermatomes and Wesselink et al. (2019) which reported higher peak sensory level with 2-CP (T9) compared to prilocaine (T10). This highest sensory level was achieved within 12 minutes in majority of the patients in the present study which is similar to the findings of Agarwal et al. (2019) which reported 14 minutes to achieve peak sensory level. The study by Lacasse et al. (2011) reported peak sensory level was achieved at 15 minutes.

In the present study, the average time of regression of sensory block to L1 was 65.91 ± 13.28 minutes. This was similar to the findings by Tandan et al. (2018), with 75 minutes as average time to regression of sensory block. The total duration of sensory block was reported to be within 100 minutes in this study. The study findings are similar to that of a previous study which reported the time taken for resolution of sensory block was 105 minutes with 2-CP compared to 225 minutes with bupivacaine [16]. This shorter duration of sensory block makes 2-CP a preferable choice for day care surgeries. In contrast to this, the study by Tanden et al. (2018) and Nivas et al. (2019) reported 140 minutes and 150 minutes respectively for the resolution of sensory block.

In the present study, the onset of motor block was within 3 minutes in all the patients and the maximum block achieved was bromage grade 3. This is similar to the findings seen in Camponovo et al. (2014) which reported early onset of motor block within 5 minutes with 2-CP compared to that with bupivacaine within 6 minutes. The maximum motor block was achieved within 15 minutes of administering spinal anaesthesia with 2-CP. The study by Nivas et al. (2019) reported 17.11 ± 3.88 minutes in achieving maximum motor block with 2-CP, which was significantly less compared to lidocaine with 18.54 ± 4.30 minutes and bupivacaine with 20.11 ± 4.13 minutes. This shows that 2-CP has faster onset of maximum motor block.

In the present study, it was observed that majority of the patients showed total regression of motor block between 75-95 mins. All patients showed regression of total motor block within 2 hours of giving spinal anaesthesia with 40 mg 2-CP. Nivas et al. (2019) observed total duration of motor block in CP group, lidocaine and bupivacaine were 96.82 ± 16.09, 115.4 ± 17.87, and 201.54 ± 64.68 minutes respectively. This highlights that 2-CP, compared to other two drugs had less duration of total motor block which again makes it a good choice for day care surgeries. This was in contrast to the findings of Tandem et al. (2018) and Wesselink et al. (2019) which reported 70 and 60 minutes respectively for full recovery from motor block among patients.

In the present study, the maximum duration for unaided ambulation was within 120 minutes of giving spinal anaesthesia with the average being 90 ± 11.52 minutes. This is similar to the findings obtained in other studies [17, 18]. Gebhardt et al. (2017) reported the mean time for unaided ambulation was 117 minutes which was significantly faster compared to general anaesthesia. Similarly, Thappa et al. (2022) reported an average time of 179.72 ± 17.30 mins for unaided ambulation with 2-CP compared to 256.52 ± 21.98 mins with bupivacaine.

In the present study, mean duration for achieving PADSS score ≥ 9 was 48.75 ± 14.65 minutes, which makes 2-CP a promising candidate for day care surgeries. Also, the average time to discharge readiness was 102.05 ± 16.5 minutes (75-135 minutes). The study by Gebhardt et al. (2017) which also used PADSS to assess discharge readiness, reported an average of 117 minutes with 2-CP. 2-CP is an amino ester which is metabolised by hydrolysis (pseudocholinesterase) and has less protein binding. These pharmacokinetic characteristics of the drug leads to short duration of action making it suitable for day care surgery where early discharge of the patient is the main goal.

There are certain limitations of the study which must be addressed. A major limitation is absence of patient follow up post discharge. As male patients of only TVH were included, it is difficult to generalise the data for other day care surgical procedures or female patients. Also, the sample size of the study is small which also makes the generalisability of findings difficult. Lastly, the study only evaluated effectiveness of 40 mg dose of 2-CP which may not be the same for other doses of 2-CP used clinically.

It can be concluded that, for the day care surgery, intrathecal injection of 40 mg of 1% 2-CP, when used in spinal anaesthesia, shows faster action in terms of onset and offset of sensory and motor blocks. It also provided early ambulation and thereby early discharge readiness, with haemodynamic stability and minimal side effects. 2-CP in spinal anaesthesia can be used for infra umbilical day care surgeries like knee arthroscopy, TVH surgery, haemorrhoidectomy, cervical polypectomy, etc. It is a very useful alternative for surgeries lasting for less than 60 minutes under spinal anaesthesia at periphery where budget of health care system is limited. Further studies with larger sample size must be conducted to evaluate various doses of 2-CP in different day care surgeries to optimise day care surgical procedures for the patients.

Conflict of interest

The authors have no conflict of interest to declare.

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