|Year : 2020 | Volume
| Issue : 3 | Page : 120-124
Comparative clinical evaluation of intrathecal bupivacaine heavy, bupivacaine with magnesium sulphate and bupivacaine with neostigmine for infraumbilical surgeries – A clinical study
Jitendra Kushwaha, Surendra Raikwar, Sandeep Rathore
Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India
|Date of Submission||20-Jul-2020|
|Date of Acceptance||10-Aug-2020|
|Date of Web Publication||22-Sep-2020|
Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Aim: This study aims to assess the anaesthetic effects of adjuvant therapies with neostigmine or magnesium sulphate compared with bupivacaine intrathecally, alone in patients undergoing infraumbilical surgeries under subarachnoid block. Materials and Methods: After approval from the Institutional Ethics Committee and informed written consent from patients, the present study was carried out in 90 patients of ASA Class I and II, aged between 18 and 50 years, of either sex (M and F), scheduled for elective infraumbilical surgeries. The selected patients were randomly divided into three equal groups of 30 patients. Group I patients received bupivacaine heavy (0.5%) 3 ml (15 mg) +0.5 ml normal saline. Group II patients received bupivacaine 3 ml (5 mg) with preservative-free magnesium sulphate 0.5 ml (50 mg). Group III patients received bupivacaine (3 ml) with neostigmine 0.5 ml (25 μg). The parameters assessed were the duration of sensory and motor blockade, quality of block, perioperative haemodynamic effects and duration of post-operative analgesia. Results: Addition of 50 mg of magnesium sulphate significantly increases the duration of sensory block in Group II (397.67 ± 14.003) as compared to Group III (188.67 ± 23.887) and Group I (183.10 ± 8.185), duration of motor block in Group II (213.67 ± 13.767) as compared to Group III (164.67 ± 23.154) and Group I (177.30 ± 7.312), duration of analgesia in Group II (349.00 ± 22.453) as compared to Group III (327.83 ± 31.61) and Group I (241.33 ± 16.399). Haemodynamic parameters were stable in both Groups I and II. Quality of block was much better in Group II (3.83 ± 0.40) as compared to Group III (3.49 ± 0.68) and Group I (2.83 ± 0.79). Conclusion: According to the results obtained from the present study, it is concluded that addition of 50 mg of magnesium sulphate as an adjuvant to intrathecal bupivacaine is better in view of the duration of sensory and motor blockade, quality of block and duration of analgesia (requirement of rescue analgesia) without any significant increase in adverse effects.
Keywords: Bupivacaine, magnesium sulphate, motor block, neostigmine, sensory block, subarachnoid block
|How to cite this article:|
Kushwaha J, Raikwar S, Rathore S. Comparative clinical evaluation of intrathecal bupivacaine heavy, bupivacaine with magnesium sulphate and bupivacaine with neostigmine for infraumbilical surgeries – A clinical study. Adv Hum Biol 2020;10:120-4
|How to cite this URL:|
Kushwaha J, Raikwar S, Rathore S. Comparative clinical evaluation of intrathecal bupivacaine heavy, bupivacaine with magnesium sulphate and bupivacaine with neostigmine for infraumbilical surgeries – A clinical study. Adv Hum Biol [serial online] 2020 [cited 2021 Mar 1];10:120-4. Available from: https://www.aihbonline.com/text.asp?2020/10/3/120/295841
| Introduction|| |
Subarachnoid block is the most common and simple technique for ambulatory surgery and for major surgery when combined with long acting intrathecal opioids, extradural or regional lower limb block.
Regional anaesthesia is widely used to let the performance of different surgical procedures including those performed below umblicus. Previous studies have demonstrated that both subarachoid and epidural block tend to have reduced blood loss and occurrence of deep venous thrombosis, less general induced adverse effects such as nausea, vomiting, sore throat, alteration of mental status and cognitive dysfunction and allowing an improved pain control.,
Regional techniques may lead to blockade or reduced pain ranged from several hours to several days. Better pain control may result in an earlier hospital discharge and may improve the patient stability in post-operative period. In addition, it is usually easy to administer and readily available.
It has become a common practice to use different therapeutic regimens for treating intra- and post-operative pain and increasing the regional anaesthetic period, because no drug has yet been identified to have this advantage without associated therapeutic side effects. One method to increase the duration and reduce side effects is to administer combinations of other classes of analgesics with local anaesthetics.
Intrathecal neostigmine has been shown to prolong motor and sensory blockade and reduces post-operative analgesic requirements. It inhibits the breakdown of 3 acetylcholine in dorsal horn and spinal meninges, therefore increasing acetylcholine concentration, which causes analgesia through action on spinal cholinergic muscarinic receptors M1 and M2. We choose a dose of 25 μg because this dose would be unlikely to cause side effects and has produced evidence of analgesia in clinical trials.,
Magnesium blocks calcium influx and is a non-competitive antagonist to NMDA receptors; it has the ability to prevent central sensitisation from peripheral nociceptive stimulation.
Due to the fact that both neostigmine and magnesium sulphate have shown effects on local anaesthetic effects, we considered these two drugs and compared their equivalent doses effects as an adjuvant. Because the effects of adding these two non-opioid drugs in such a concentration and comparing their effects have not studied formerly.
The purpose of this study was to assess the anaesthetic effects of adjuvant therapies with neostigmine or magnesium sulphate compared with bupivacaine intrathecally, alone in patients undergoing infraumbilical surgeries under subarachnoid block.
| Materials and Methods|| |
In this comparative observational hospital based study, a total of 90 patients of ASA class I and II, aged between 18 and 50 years, of either sex (M and F), scheduled for elective infraumbilical surgeries were included in this study.
After approval from the Institutional Ethics Committee, all the patients were subjected to detailed pre-anaesthetic evaluation with clinical history, thorough physical and systemic examination, routine investigation which include complete blood count, urine (routine and microscopy), blood sugar, renal function test, serum electrolytes, X-ray chest posteroanterior view, electrocardiogram (ECG) and any special investigation if required was done for the study. Informed written consent was obtained from all the patients enrolled for the study.
The patients with neurological disease, spinal or neurological deformity, skin infection at the site of subarachnoid block, bleeding diathesis, history of drug allergy to bupivacaine, magnesium sulphate and neostigmine, severe heart and liver disease were excluded from the study.
The patients were randomly divided into three groups of 30 patients each with the help of a random number table. The groups were assigned as Group I, II, III, respectively. Group I patients received bupivacaine heavy (0.5%) 3 ml (15 mg) +0.5 ml normal saline. Group II patients received bupivacaine 3 ml (15 mg) + preservative free magnesium sulphate 0.5 ml (50 mg). The 50 mg MgSO4 was prepared by 1 ml of MgSO450% plus 5 cc Normal Saline 0.9%. Group III patients received bupivacaine (3 ml) + neostigmine 0.5 ml (25 μg). The 25 μg neostigmine was prepared by 1 cc of neostigmine 0.5% plus 10 cc Normal Saline 0.9%. Materials required for the procedure is Spinal trolley with 25G quinckes type spinal needle, 2 ml and 5 ml disposable syringes, lignocaine 2% vial for local infiltration. All equipments necessary for resuscitation were kept ready such as emergency drugs, cardiopulmonary resuscitative equipment and oxygen sources. Drugs required for the study include, one ampoule of bupivacaine 0.5% (H), one ampoule of neostigmine (0.5 mg/ml) and one ampoule of magnesium sulphate (50% W/V).
After shifting patient in operation theatre, a careful preoperative examination along with history was taken. Peripheral line was secured by inserting intravenous cannula (18–20G), preloaded with ringer lactate solution 15 ml/kg. All the monitoring equipment (like NIBP Cuff, Pulse oxymetry, ECG) were attached to the patient and baseline values of heart rate, blood pressure, SpO2 and respiratory rate were recorded. Patients were kept in supine position. Injection Ondansetron 0.1 mg/kg and injection Ranitidine 0.5 mg/kg was given intravenously to all the patients prior to induction. After strict aseptic precautions, skin and subcutaneous tissue was infiltrated with 2% injection lignocaine, then subarachnoid block was performed in sitting position, using midline approach with 25 G spinal needle in L3–L4 intervertebral space. After the appearance of free flow of cerebral spinal fluid, the mixture of drugs according to assigned group was injected. Utmost care was taken to avoid any leakage of any of these drugs. The spinal needle was removed and patient was immediately turned to supine position.
Various parameters were then assessed and recorded on a prescribed pro forma such as duration of sensory block (time for regression of sensory block to S2 dermatome was), motor block (time to achieve grade 0 motor blockade from grade 3 motor blockade), quality of block[Grade 1-(unsuccessful) patient needs general anaesthesia Grade 2-(moderate) complaints that require supplemental analgesia. Grade 3-(good) minor complaints with no need of supplemental analgesia. Grade4-(excellent) no complaints], duration of analgesia (time from intrathecal injection of drug until the patient request for additional analgesia, which further assessed by visual analogue score of ≥4).
Demographic parameters such as age, height, weight, sex were also recorded on prescribed pro forma. Haemodynamic variables such as heart rate, blood pressure, respiratory rate, systolic and diastolic blood pressure, SpO2 were recorded preoperatively and at 5th min, 10th min and 150th min. The surgical anaesthesia was considered effective when T6-8 dermatome was anaesthetised and grade 3 motor block was achieved. After establishment of adequate level of block up to T10, surgery was started and time of beginning of surgery and duration of surgery was noted. Patients were given oxygen by oxymask at 4 L/min. All the patients were observed for any adverse effects in the intraoperative and post-operative period for 24 h.
All the data in the form were filled using Microsoft excel sheet. Statistical procedures were carried out in two steps that are data compilation and presentation and Statistical analysis. Statistical analysis was done using Statistical Package of Social Science (SPSS Version 20; Chicago Inc. USA). Data comparison was done by applying specific statistical tests to find out the statistical significance of the comparisons. Quantitative variables were compared using mean values and qualitative variables using proportions. Significance level was fixed at P < 0.05. Statistical tests employed for the obtained data in our study were Chi-square test, analysis of variance, Post hoc Tukey HSD (Honestly Significant Difference).
| Results|| |
A total of 90 patients were included in the study based on inclusion and exclusion criteria with 30 in each group.
[Table 1] shows age, height and weight distribution in the three groups. All the patients were 18–50 years old. Mean age was 34.67 years in Group I, 33.87 years in Group II and 36.77 years in Group III. Mean height was 167.43 cm in Group I, 167.53 cm in Group II and 165.00 cm in Group III. Mean weight was 54.10 kg in Group I, 55.50 kg in Group II and 56.13 kg in Group III. There was statistically no significant difference found in age, height and weight between three groups.
[Table 2] shows demographic profile of patients in three groups according to gender. Out of 90 patients 51 (56.7%) were male and 39 (43.3%) were female. There was statistically no significant difference found in distribution of patients according to gender, (P = 0.873).
|Table 2: Demographic profile of patients according to gender in three groups|
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[Table 3] shows comparison of duration of sensory blockade (min) in three different groups. Duration of sensory blockade was maximum in Group II i.e., 397.67 ± 14.003 min and it was minimum in Group I i.e., 183.10 ± 8.185 min. There was statistically highly significant difference found in duration of sensory blockade between three groups, (P = 0.001). Duration of motor blockade was maximum in Group II i.e., 213.67 ± 13.767 min and it was minimum in Group III i.e., 164.67 ± 23.154 min. There was statistically highly significant difference found in duration of motor blockade between three groups, (P = 0.001). [Table 3] shows of analgesia (min.) in three different groups. Mean duration of analgesia was maximum in Group II i.e., 349.00 ± 22.453 min and it was minimum in Group I i.e., 241.33 ± 16.399 min. There was statistically highly significant difference found in duration of Analgesia between three groups, (P = 0.001). It also shows comparison of quality of block in three different groups. Mean quality of block score was highest in Group II i.e., 3.83 ± 0.46 min and it was minimum in Group I i.e., 2.83 ± 0.79 min. There was statistically highly significant difference found in quality of block between three groups, (P = 0.001) The mean duration of surgery was 91.50 min in group I, 93.00 min in group II and 91.00 min in group III. There was statistically no significant difference found in duration of surgery between three groups, (P >0.05).
|Table 3: Comparison of duration of sensory blockade,motor blockade,duration of analgesia,quality score and duration of surgery in three groups.|
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Among the complications, nausea was seen amongst three patients intraoperatively and in one patient in post-operative period in Group III. Shivering was found in two patients intraoperatively in Group I and in one patient in Group III. Bradycardia was seen only in one patient in Group III. Vomiting was seen in one patient postoperatively in Group I, II and III and in two patients intraoperatively in Group III. Pruritus was not seen in any of the patients.
| Discussion|| |
Neuraxial blocks are now a days most popular and commonly used than ever since the late 19th century (1885) for infraumbilical surgeries. Subarachnoid block is preferred over epidural block, because of its rapid onset, good density block, lower failure rates, no catheter-related complications and cost-effectiveness, but has the limitations of shorter duration of block and inability to extend the analgesia into the post-operative period. In recent years, the use of intrathecal adjuvants has gained popularity, with the intention of reducing the dose of local anaesthetics, maintaining haemodynamic stability, delaying the onset of pain during the post-operative period, and thus reducing the demand for post-operative rescue analgesics. Addition of adjuvants ensures faster recovery, enabling patients to return to their routine activity more quickly. Most commonly used adjuvant in central neuraxial blocks are opioids, however, their adverse effects such as respiratory depression, nausea, vomiting, hypotension, constipation and pruritus have prompted further research to develop nonopioid adjuvants with less worrisome side effects.
Magnesium sulphate is NMDA receptor antagonist. N methyl D aspartate receptors play an important role in neuronal plasticity and processes leading to central sensitisation of pain. Intrathecal Magnesium sulphate blocks NMDA receptors at dorsal horn thus preventing central sensitisation to pain and improving anaesthetic and analgesic quality.
Hoodet al. in 1997 reported postoperative analgesia of intrathecal neostigmine, first reported post-operative analgesia of intrathecal neostigmine acholinesterase inhibitor, the effectiveness of which being comparable to morphine. Several studies suggest neostigmine as an effective adjuvant to prolong the duration of the subarachnoid block with better haemodynamic stability. Many studies showed that there is synergism between intrathecal neostigmine with local anaesthetic agents. Considerable evidence exists to implicate the role of cholinergic agonists and anticholinesterase agents in the spinal inhibition of nociceptive transmission. Intrathecal administrations of neostigmine produce antinociception, which is mediated by spinal muscarinic and nicotinic receptors in animals and human beings. It produces analgesia by releasing of nitric oxide and inhibiting the metabolism of acetylcholine and binding to M1 and M3 muscarinic and to nicotinic receptors. Whereas local anaesthetic agents/bupivacaine act by blocking voltage gated Na+ channels in spinal cord.
Since all the groups were demographically similar (P > 0.05 in all the comparisons), it can be presumed that the groups are comparable for the purpose of the study.
All the patients of study group were preloaded with ringer lactate to counterbalance the effect of relative hypovolemia or hypotension.
In this study, we showed that magnesium 50 mg when added to bupivacaine-fentanyl combination for spinal anaesthesia could provide prolonged post-operative analgesia without additional side effects in patients undergoing lower limb orthopaedic surgery and also prolongs the duration of sensory blockade.
Malleeswaran et al. in their study also observed similar results with a combination of bupivacaine-fentanyl and magnesium intrathecally in patients with mild preeclampsia undergoing caesarean section. Arcioni et al. also observed that intrathecal and epidural magnesium sulphate, potentiated and prolonged the motor blockade.
Unlugenc et al. in their study showed prolongation of the duration of sensory block in magnesium group.
Dayioǧlu et al. also concluded from their study that addition of intrathecal magnesium sulphate to subarachnoid block, prolonged the time to first analgesic requirement.
In our study, all the patients were haemodynamically stable in all the three groups with respect to pulse rate, systolic blood pressure and diastolic blood pressure, respiratory rate and SpO2(P > 0.05).
In our study, the incidence of nausea, vomiting and shivering, showed no significant difference among the three groups and this may be related to similar haemodynamic and absence of significant hypotension among groups. Bradycardia was observed only in one patient of Group III. Pruritus was not seen in any patient.
| Conclusion|| |
We carried out our study in 90 patients divided into three groups. The study was carried out to compare the effect of intrathecal magnesium sulphate 50 mg, intrathecal neostigmine 25 μg added to intrathecal bupivacaine heavy and found that both can be used to prolong the duration of sensory and motor block, duration of analgesia and quality of block and it is prolonged more significantly with magnesium sulphate as compared to neostigmine.
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[Table 1], [Table 2], [Table 3]