European Journal of Cardiovascular Medicine

Historical Development: When Prof. August Karl Gustav Bier successfully administered spinal anesthesia to his buddy Hildebrandt in 1898, he was the first to do so. Its application in medicine started at this point.

In recent decades, improvements in anesthetic and surgical methods have contributed to the growth of day care surgery1. Early bladder control and mobility restoration, efficient surgical pain management, and quick anesthetic onset and offset are all desirable outcomes, all while reducing side effects1. Regional anesthesia, especially spinal anesthesia, has become the preferred technique due to its benefits, even if general anesthesia with short-acting drugs has previously been preferred^[1].

Perianal operations, which make up a sizable percentage (10%) of general recommendations, require a careful balancing act between rapid start, prolonged anesthetic, low side effects, and rapid recovery for release on time^[2]. In regional anesthesia, subarachnoid block (SAB), commonly referred to as intrathecal block, is a flexible approach that has benefits including lowering intraoperative bleeding, blunting the stress response, and producing postoperative analgesia^[3,4].

Local Anesthetic Agent Evolution: The first local anesthetic used for spinal block was cocaine. Procaine, tetracaine, lidocaine, chlorprocaine, and mepivacaine are among the other local anesthetic solutions that have been developed over time. The safety profile of 0.5% buprevacaine above 5% lidocaine made it more popular, particularly in light of reports of temporary neurological side effects linked to the latter. The use of long-acting local anesthetics for ambulatory procedures is limited because, although increasing the dosage may result in greater sensory blocks, it also carries the risk of extended motor blockade, arterial hypotension, and delayed discharge. By using short-acting spinal anesthetics with less motor block, patients may recover and mobilize more quickly, improving their outcomes^[5].

Bupivacaine and Ropivacaine's introduction Since its initial effective use in 1966, intrathecal bupivacaine has been widely utilized in spinal anesthesia. With its positive qualities, including low lipid solubility and a high pKa, and its lower toxicity profile, ropivacaine, which was first used in the 1980s, shows promise as a treatment for daycare procedures by encouraging early post-operative mobilization6. Bupivacaine, a long-acting aminoamide and local anesthetic that provides sustained pain relief, is a major development in the field of local anesthesia^[7]. In this regard, the current study evaluates the clinical effectiveness of hyperbaric buprevacaine 0.5% and hyperbaric ropivacaine 0.75 in order to further the continuous improvement of local anesthetic procedures. The study aims to determine the best option for obtaining quick, dependable anesthetic through a randomized assessment.

The present study was conducted in the Government General Hospital, Nizamabad, Telangana, India.

STUDY DESIGN: Randomized control study.

STUDY PERIOD: 12 months

STUDY DURATION: September 2022 to August 2023

STUDY SETTING: Government General Hospital, Nizamabad, Telangana, India

STUDY POPULATION: Patients admitted  to Government General Hospital, Nizamabad, Telangana, India for peri-anal surgeries

ELIGIBILITY CRITERIA:

INCLUSION CRITERIA:

• Patients classified as American Society of Anaesthesiologists (ASA) grade I and II.
• Age 25 to 50 years.
• Body weight between 40 and 80 kilograms.
• Scheduled for elective peri-anal surgical procedures.
• Patients who have provided valid informed written consent.

EXCLUSION CRITERIA:

• Lack of informed written consent
• Patients categorized as American Society of Anaesthesiologists (ASA) grade III and IV
• History of allergic reactions to local anesthetic agents
• Previous medical history indicating seizures and neurological deficits
• Severe renal, hepatic, respiratory, or cardiovascular conditions
• Presence of coagulation disorders

One hundred ASA grade I and II patients of either sex and ages 25 to 50 who were scheduled for various perianal procedures participated in randomized research. A computer-generated randomization table was used to randomly split the 100 chosen patients into two groups of 50 each following Institutional Ethical Committee approval and signed informed agreement. A comprehensive pre-anesthetic evaluation was conducted, which included a history, a systemic and general examination, and all pertinent investigations.

Patients in Group R were given 2.5 milliliters of 0.75% hyperbaric ropivacaine, while those in Group B were given 2.5 milliliters of 0.5% hyperbaric bupivacaine. Prior to surgery, all patients were held at zero orally for four to six hours. All patients were given 150 mg of ranitidine and 0.5 mg of alprazolam the night before surgery. An appropriate peripheral intravenous (IV) access was made using an 18-gauge cannula as soon as the patient arrived in the preoperative room. Before moving into the operating room, premedication was completed with an intravenous injection of ranitidine 50 mg and ondansetron 4 mg. For 15 minutes, preloading was carried out using 10–15 ml/kg of Ringer Lactate or regular saline. The following parameters' baseline values were noted: pulse rate (PR), noninvasive blood pressure (NIBP), saturation (SPO2) and respiratory rate (RR). Every patient was put in a seated posture. A 25G Quinke spinal needle with the bevel end facing the cephalad was used to perform a lumbar puncture under rigorous asepsis utilizing a midline approach at the interspinous regions L3-L4 or L4-L5. The prepared anesthetic medications (ropivacaine or buprevacaine) were delivered over a 10-second interval when clear CSF was obtained.

TABLE 1: AGE DISTRIBUTION OF STUDY PARTICIPANTS

FIGURE 1: Age Distribution Of Study Participants

Table 1 and Figure 1: Represent the age distribution of the study participants. The majority of participants were in the age range of 31-35 years, constituting 42% of the sample, followed by those aged 26-30 years, representing 32%. Participants aged 20- 25 years and 36-40 years accounted for 18% and 8% of the sample, respectively. There were no participants aged 41-45 years or 46-50 years in the study.

TABLE 2: Gender Distribution Of Study Participants

FIGURE 2: Gender Distribution Of Study Participants

Table 2 and Figure 2: Illustrate the gender distribution among the study participants. The majority of participants were male, comprising 66% of the sample, while females accounted for 34%.

TABLE 3: Anthropometric Distribution Of Study Participants

FIGURE 3: Anthropometric Distribution Of Study Participants

Table 3 and Figure 3: Represent the anthropometric distribution of the study participants. The mean height of the participants was 163.20 ±5.68 cm. The average weight was 61.58 ±6.38 kg. Additionally, the mean BMI was calculated to be 22.1±1.26 kg/m².

TABLE 4: Demographic Profile Of Participants In Group R And Group B

Independent t-test Chi-square p≤0.05 is statistically significant

Table 4: Represents the demographic characteristics of participants enrolled in the Hyperbaric Ropivacaine [Group R] and Hyperbaric Bupivacaine [Group B]. The mean age of participants in Group R was 37.89 years (SD ± 1.9), and Group B was 36.24 years (SD ± 1.6), with no significant difference observed between the two groups (p = 0.651). Gender distribution showed that in Group R, 64% were male and 36% were female, whereas in Group B, 68% were male and 32% were female, with no statistically significant difference between the groups (p = 0.732).

TABLE 5: Anthropometric Profile Of Participants In Group R And Group B

Independent t-test p≤0.05 is statistically significant

Table 5: illustrate the anthropometric characteristics of participants in Group R and Group B. The mean height of participants in Group R was 164.10 cm (SD ± 3.26), whereas in GROUP B was 161.46 cm (SD ± 5.68), with no significant difference observed between the groups (p = 0.875). Similarly, the mean weight of participants in Group R was 61.96 kg (SD ± 5.63), and Group B was 62.58 kg (SD ± 6.38), with no statistically significant difference between the groups (p = 0.931). Additionally, the mean BMI of participants in Group R was 21.6 kg/m2 (SD ± 1.8), while in Group B was 22.1 kg/m2 (SD ± 1.26), with no significant difference observed between the two groups (p = 0.644).

TABLE 6: Distribution Of Onset Of Sensory Block In Group R And Group B

Independent t-test p≤0.05 is statistically significant

FIGURE 6: Distribution Of Onset Of Sensory Block In Group R And Group

Table 6 and Figure 6: Illustrate the distribution of onset of sensory block in Group R and Group B. The mean onset of sensory block in Group R was 4.12 minutes with a standard deviation of 1.9 minutes, whereas in Group B was 3.00 minutes with a standard deviation of 1.8 minutes. A statistically significant difference was noted between the two groups (P = 0.001), indicating a faster onset of sensory block with Group B compared to Group R.

These days Perianal operations are often performed in daycare centers. In order to promote early recovery and ambulation52, preferred anesthetic procedures for ambulatory surgery should offer the best anesthetic conditions with the fewest possible adverse effects. Because of its safety, low cost, simplicity of use, and high post-anesthesia patient satisfaction, spinal anesthesia (SAB) is a commonly used treatment for perineal procedures. This method avoids the dangers of general anesthesia, such aspiration and polypharmacy, while providing a quick start and dependability. Because of its strength and low risk of neurological adverse effects, buprevacaine is frequently used in perineal procedures. It is a recommended option for spinal anesthesia due to its severe motor blockage and prolonged duration of action. But Ropivacaine, Bupivacaine's S-enantiomer, is becoming more and more well-liked for spinal anesthesia in a number of surgery, such as lower limb operations and cesarean sections.

Compared to buprevacaine, ropivacaine has the benefit of a shorter motor block duration while retaining comparable sensory blockade characteristics, which lessens the psychological pain brought on by extended immobility. Further improving its safety profile, ropivacaine is thought to be less cardiotoxic than buprevacaine. With 50 participants in each group, the purpose of this research was to evaluate the clinical efficacy of giving equivalent quantities (2.5 ml) of 0.75% hyperbaric ropivacaine as opposed to 0.5% hyperbaric buprevacaine for peri-anal operations performed under spinal anesthesia. To provide a fair comparison between the two groups, equal volumes and samples were selected.

COMPARISON OF AGE:

• In the present study, 42% of the participants fell within the age range of 31-35 years, with a mean age of 37.87 ± 1.8 years.
• This finding is consistent with previous studies conducted by Ali L et al with 35.52 ± 8.10 years⁵³.
• Furthermore, the majority of the study population (53.3%) in Gonuguntla S B study belonged to the age group of 20-30 years, while 33.33% belonged to the age group of 30-39 years in Bhukya R et al^54,55.
• Regarding the comparison between the Hyperbaric Bupivacaine and Hyperbaric Ropivacaine groups, there were no significant differences in age, which is consistent with previous studies conducted by Bennur S et al., Bhaskara B et al., Koppal R et al., Ali L et al., and Dar FA et al^1,4,6,53,56.

COMPARISON OF GENDER:

• In the present study, 66% of participants were males. This proportion aligns with findings from previous studies, such as Bennur S et al. reporting 58.3%, Bhukya R et al. with 53.33%, Kuldeep A et al. with 71.7%, and Nasr YM with 70% male participants^1,2,55,57.
• Notably, no significant difference in gender distribution was observed between the two groups, consistent with the results reported by Bhukya R et al., Mehta A. et al., and Sharma J et al.

COMPARISON OF ANTHROPOMETRIC MEASUREMENTS:

• There was no significant difference in the anthropometric measurements between Hyperbaric bupivacaine and Hyperbaric ropivacaine groups in the current study. The lack of significant difference in age, gender, and anthropometric measurements between the Hyperbaric Bupivacaine and Hyperbaric Ropivacaine groups can be attributed to the randomized allocation of participants in the study.
• In our study, groups are comparable with respect to age, gender, height, weight, and ASA grading [ p >0.05].

In summary, there were notable distinctions between the two groups in this study comparing hyperbaric ropivacaine and hyperbaric buprevacaine for peri-anal operations in ASA grade I and II patients. In comparison to Hyperbaric Bupivacaine, intra-thecal 0.75% Hyperbaric Ropivacaine has demonstrated clinically effective surgical anesthesia for perianal procedures, resulting in a quicker restoration of motor function (101.8 min vs 147.2 min), less hemodynamic changes, and a superior safety profile. It is appropriate for brief operations performed in daycare settings because of its quicker recovery features, which lead to shorter duration and a better hemodynamic profile. Early mobilization has also improved the postoperative recovery.

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