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Research Article | Volume 5 Issue 2 (July-Dec, 2024) | Pages 1 - 6
A COMPARATIVE STUDY BETWEEN FENTANYL AND CLONIDINE AS A ADJUVANT WITH ROPIVACAINE IN SPINAL ANESTHESIA
 ,
 ,
1
MD, Department of Anesthesia and Critical Care, Rajshree medical college, Bareilly, UP
Under a Creative Commons license
Open Access
Received
July 8, 2024
Revised
July 19, 2024
Accepted
Aug. 17, 2024
Published
Oct. 18, 2024
Abstract

Spinal anesthesia has been named as the first major regional intervention introduced in our clinical practice. Spinal anesthesia, known as subarachnoid block is a safe technique. It is very reliable, cost effective and is easy to administer. Subarachnoid block works by providing surgical anesthesia with prolonged post-operative pain relief after surgery using various local anesthetic agents alone or in combination with adjuvants such as opioids, NMDA receptor antagonist. It blunts the autonomic and somatic responses. It has a quick onset associated with an effective blockage of sensory and motor system. It was first performed in by August Bier and from then on has been practiced widely. This study was done in Bareilly, UP where disparities in healthcare resources highlight the need to find the better adjuvant for effective sensory and motor block and quality of postoperative analgesia. Materials and Methods - A simple random sampling was done with 60 adult patients from the interval of May 2022 to 30th May 2024 at Rajshree medical college, Bareilly, UP. Participants were selected through random sampling to ensure demographic diversity. Data were collected through structured interviews, covering demographics, knowledge of adjuvants, sources of information and factors affecting spinal anesthesia levels. Statistical analysis was performed using SPSS version 23, null hypothesis significance testing and sample size program. Continuous variables such as age, income were expressed in terms of median, interquartile range, maximum and minimum. The outcome variables which were nominal expressed in terms of frequencies and percentages.Further Chi- square test or Fischer’s test was used.Results – The study revealed a balanced demographic distribution among participants, with equal representation of genders and a broad age interval. A comparative study with sixty patients of the age- range of 20 to 60 from ASA I & II participated in the study. Two groups, A and B, were randomly assigned to patients. The onset of sensory and motor blockage was equal in both groups. The duration of sensory and motor block were longer in clonidine plus ropivacaine group. The postoperative analgesia quality is also better in group having clonidine as adjuvant. Our research leads us to the conclusion that clonidine added to ropivacaine administered intrathecally improves sensory and motor blockage with improved hemodynamic stability, The slower regression of the block in the group receiving ropivacaine with clonidine, made it a better choice for longer duration lower limb surgery. When ropivacaine plus clonidine was used instead of ropivacaine plus fentanyl, the mean time for the initial rescue analgesia was longer, which decreased the need for analgesics in the early post-operative phase.

Keywords
INTRODUCTION

Ropivacaine is a local anesthetic agent which acts for long duration by acting on Na+- channels selectively. It causes shorter duration of motor block. Its lipid solubility is less and has small volume of distribution. Its half life is shorter than bupivacaine. Ropivacaine is isobaric in nature[1]. The motor blockage caused by it, is of short duration and not so intense. Ropivacaine in concentration of 0.75% cause less intense motor and sensory block then bupivacaine in 0.5% concentration. When used for lumbar epidural labor analgesia and c section its potency is equal to bupivacaine. Ropivacaine is use for analgesia, peripheral nerve blocks, local infiltration, caudal block, spinal anesthesia and in epidural anesthesia also. In epidural and other blocks bupivacaine and ropivacaine has equal intensity of sensory anaesthesia. Bupivacaine is more potent than ropivacaine if it is use in less doses such as in spinal anesthesia and epidural analgesia[2]. Ropivacaine is widely available in isobaric form and so the hyperbaric form is prepared by adding dextrose to it. This needs caution as the addition of dextrose may have

 risk of infection. Ropivacaine in concentration of 10mg/ml formulation is suggested for epidural anesthesia which needs complete motor block. Ropivacaine has a larger therapeutic index. It is less likely to cause cardiac arrhythmias. It is tolerated by CNS nicely.The improved safety profile is due to its low lipid solubility. Ropivacaine causes less severe CNS and CVS toxicity when compared to bupivacaine and leads to an great degree of dissociation between motor and sensory effects leading to less intense motor blockade and more rapid recovery to complete mobilization[3] . Bupivacaine is available in isobaric and hyperbaric preparations. It consists of S and R enantiomers. R -enantiomers has greater affinity and binding time for sodium channels. R -bupivacaine is cardiotoxic and arrhythmogenic. It decreases ventricular function by 4.6 times. Ropivacaine consists of only S- enantiomer so it is less cardiotoxic. Ropivacaine penetrate less in large myelinated motor fibers because of lower lipid solubility than bupivacaine causing relatively reduced motor blockade. Variety of opioids are used as adjuvants such as morphine, sufentanyl, fentanyl, hydromorphone, buprenorphine and tramadol. However, their adverse effects have restricted their use. Combination of local anesthetics with opioids has adopted widely because they provide a synergistic effect by its action in the spinal cord directly. 

Fentanyl is a lipid soluble opioid. It acts directly on opiod µ1 and µ2 receptors. It intensify the sensory block which leads to further reduction in doses of local anesthetic agents. It is rapid in onset and the effects generally last approximate of two hours. In comparison to morphine, intrathecal fentanyl in doses of 10-25 μg lengthens and deepens the sensory block while having fewer side effects. But if it is given epidurally then it might not follow the same patternClonidine is from imidazole family which has selective partial agonist activies. It works on post-junction alpha-two adrenoreceptor in spinal column. In neuraxial anesthesia, it blocks sympathetic outflow locally. Clonidine has been demonstrated to be helpful in a variety of procedures when administered epidurally at dose upto 25-50 mcg/hr. Clonidine if used intrathecally leads to increase in spread of sensory block and reduction in failure rate and addition of analgesia[2]. In neuraxial blocks with clonidine has side effects like sedation, hypotension and bradycardia therefore leading to recommendations of lower dosages. This study aims to compare between fentanyl and clonidine as a better adjuvant with ropivacaine in spinal anesthesia in terms of effective sensory and motor blocking effects and quality of post-operative analgesia. Through this exploration in context of  Bareilly,UP, the study aims to offer recommendations that could be relevant for the knowledge of effective anesthesia  and postoperative analgesia by the adjuvants.

MATERIAL AND METHODS

STUDY DESIGN AND PLACE OF STUDY: 

This simple random sampling was conducted at department of anesthesia at Rajshree medical and Research institute, Bareilly, UP. This institution serves a diverse population, making it an ideal setting for assessing the effectiveness of adjuvants when added to ropivacaine in spinal anethesia for lower body procedures.

 

SAMPLING: 

The study population comprised a calculated sample size of 60 adults aged from 20 and above residing in the catchment area of the medical college. This sample size was determined based on the Cochran formula for the sample size calculation in patients surveys who are posted for procedures under spinal anesthesia, assuming a 50% response distribution for maximum sample size, a 5% margin of error, and a 95% confidence level. Random sampling was employed to ensure the sample was representative of the population in term of age, gender, weight, socioeconomic status and educational background. The patients who meets the exclusion and inclusion criteria during the period of study will be randomly allocated in two groups using computer generate random table.

 

INCLUSION CRITERIA includes Written informed consent., Grade 1 & 2 of American society of anesthesiologists (ASA), Age Group: age in the range of 20 to 60 and Patients of lower limbs and lower abdominal surgeries. 

 

EXCLUSION CRITERIA includes patient refused to participate in the study, Absolute and relative contraindications of Spinal Anesthesia, Contraindication to fentanyl and clonidine, Contraindication to ropivacaine, Underlying Cardiac Disease (Arrythmia), LSCS and Anxiety prone patients or diagnosed psychological morbidity.

DATA COLLECTION

Patients undergoing spinal anesthesia will be selected for our study. The day before the 

surgery, a thorough pre-anaesthetic assessment was performed out, and signed informed –consent to take part in our study was obtained. The night before the procedure, a 150 mg ranitidine tablet and a 0.25 mg tab of alprazolam were administered orally. Group A and Group B are the two random groupings into which the patients will be divided. After that, the patient will be brought to the operating theatre. Then a routine non –invasive monitoring will be done. A 18 G catheter will be placed in patient’s non-dominant hand, and Ringer's lactate 15 mL/kg solution was given within twenty minutes followed by calculated fluid according to Holliday-Segar formula. The patients in both the groups will be given spinal anesthesia with the ropivacaine spinal anesthetic agent at L2-3, L3-L4 space via median / paramedian approach in lateral position/sitting position under sterile fashion. Spinal blockage with ropivacaine will be given to equal number of patients in two groups (group A: 0.75% Ropivacaine with 20.0 mcg Fentanyl and B group: ropivacaine 0.75 %, plus 30 mcg clonidine). Immediately following the spinal injection, patient`s was placed in supine position. The patient's sensory and motor blockages were assessed. For the first twenty minutes, the patient's motor and sensory block was assessed every two minutes. After that, it was assessed every five - minutes for forty minute, and then every fifteen minutes until to the time that sensory block had regress to S1 dermatome. Systolic and diastolic readings, heart rate, and MAP were all recorded concurrently. Pinprick sensation loss using a 24-gauge hypodermic needle in a caudal to cephalad direction was used to measure the degree of sensory block, and the modified Bromage scale was used to measure motor block.

 

Modified Bromage scale 

0:  No motor block

1:  Inability to raise extended leg; able to move the knees and feet

2: Inability to raise extended leg and move the knee; able to move the feet

3: Complete block of motor limb

After surgical anaesthesia was achieved, Surgery readiness was determined by modified Bromage ≥2 and pin prick sensation loss of level T10. Neurological and motor functions during the process were observed from the non-functional side. An intravenous injection of 0.02 mg/kg of butorphanol was given to a patient who complained of pain during surgery. When this proved insufficient to finish the surgery, general anesthesia was administered, and the study was terminated. When the patient asked for rescue analgesia, that was taken into account as the beginning of postoperative pain. Tramadol 1 ampule IV injection was used to provide analgesia.Vital parameters heart rate, SBP, MAP, DBP and SPO2 will be monitered. Treatment for clinically significant hypotension involved a fast intravenous infusion of  two hundred millilitres of Ringer's lactate solution over ten -minute period. Clinically significant hypotension is determined as a fall in systolic [SBP] arterial blood pressure of ≥30% from baseline values. 6 mg of  Mephentermin was given intravenously when it was determined that this was ineffective. 0.5 mg of atropine IV was used to treat the incidences of clinically significant bradycardia, which is determined as a heart rate drop of ≤50 beats per minutes. Up to 24 hours following surgery, all complications, side effects, and adverse effects were documented.

 

Ethical considerations 

The institutional review board [IRB] of Rajshree Medical Research Institute approved the study protocol. Participants provided written informed consent, and the study adhered to the Declaration of Helsinki`s ethical guidelines.

OBSERVATIONS AND RESULTS

The study population consisted of 60 patients, which were randomly divided into 2 groups of 30 each. Group A – was administered 0.75% Ropivacaine with 20.0 mcg Fentanyl and Group B – was administered Ropivacaine 0.75%, with 30 mcg Clonidine.Following are the observation made during the study.

 

Table-1 mean age and weight in group a and group b.

 

      Group A

     Group B

 

 

     Mean ± SD

    Mean ± SD

 P-Value

        AGE

       41.3 ± 8.49

  1.  ± 9.28

  0.915#

      WEIGHT

       65.2 ± 10.55

     

    63.23 ± 9.35

 

     0.448#

#not significant.

Table-2 sex distribution

 

   SEX

    Total

P-Value

F

M

            GROUP

 A

7

23

30

 

 

0.390#

 B

10

20

30

             Total

17

43

60

#not significant.

Mean weight of patient in group A was 65.2 ± 10.55 kg and 63.23 ± 9.35 kg in Group B, there were 23 male and 7 females in group A and 20 male and 10 females in group B.

There was no significant difference in age, sex and weight in between group A and group B.

 

Table-3 onset of sensory and motor block

 

     Group A

    Group B

 

 

    Mean ± SD

    Mean ± SD

   P-Value

 onset of 

sensory 

 blockade


 

 onset of motor

 blockade                     

  6.93 ± 1.64

 

 

 

10.13 ± 2.03

6.20 ± 1.42

 

 

 

9.40 ± 1.67

 0.069#

 

 

 

0.132#

#not significant.

Table-4 duration of sensory and motor block

 

Group A

Group B

 

 

Mean ± SD

Mean ± SD

P-Value

  Duration of sensory Block

 

  1.  

0.045*

  Duration of motor block

 

167.20 ± 19.9        175.67 ± 14.96

   0.046* 

 

     

*Statistically significant

There was significant difference in mean duration of sensory block in between group A and Group B (value 0.045) showing that the duration of sensory block was also more in group B. Duration of motor block was significantly more in group B as compared to group A (p value 0.046).

Table- 5 numerical rating scale

 

    Group A

     Group B

 

 

   Mean ± SD

 Mean ± SD

   P-Value

Numerical rating scale

   4.37 ± 1.33

  1. ± 1.21

0.001*

* Statistically significant.

The mean Numerical rating scale was > 4 in group A then group B.

 

Table- 6 time for first rescue analgesia

 

    Group A

    Group B

  •  

 

    Mean ± SD

    Mean ± SD

   P-Value

time for first rescue

Analgesia

   219.47 ± 20.43

  237.73 ± 18.37

 0.001*

* significant.

The mean time for first rescue analgesia was more in group B as compared to group A.

 

 

 

Statistical Analysis

The data obtained from the completed questionnaires were manually entered in Microsoft Excel [version office 365]. The data was appropriately recorded for the variables. The final sheet was imported into R version4.2.3 using the “readxl” package and further analysis was done using SPSS v 23.Continuous variables such as age, income were expressed in terms of median, interquartile range, maximum and minimum. The outcome variables which were nominal expressed in terms of frequencies and percentages.Further Chi- square test or Fischer’s test was used to find association between categorical variables and the Wilcoxin rank-sum test and welch two samples t.test was used for the continuous variables as per the normality of data.Descriptive analysis summarized demographics and awareness levels. Chi-Square tests and logistics regression analyzed demographic associations with awareness.

DISCUSSION

For lower body procedures, spinal anesthesia is a widely utilized technique. Both the patient's characteristics and the drug's dissemination affects central neuraxial blocking. Factors related to the patient include age, height, posture, spinal column structure, and volume of CSF.A number of variables, such as dosage, volume, density, specific gravity, baricity of solution,and drug potency, influence how quickly a medicine spreads.[4] In addition to the aforementioned factors, the drug's dosage, rate of administration, and barbotage method all affect how quickly it spreads. As the drug is given, its concentration decreases. This decrease is caused by several factors, including CSF mixing and dilution, distribution and diffusion to neural tissues, neural tissue fixation and uptake, and vascular - elimination and absorption through the arachnoid villi.The patients in our study were segregated into two groups - A and B, each with 30 members. According to Table 1, the mean age of the subjects in Group A was 41.3 ± 8.49 years, while the mean age of the subjects in Group B was 40.53 ± 9.28 years. These results were comparable (p>0.05), Similarly, the patient's mean weight was similar (p>0.05) at 65.2 ± 10.55 kg in group A and 63.23 ± 9.35 kg in group B [Table 1]. The gender in both the group were comparable, Group A male 76.6% female 23.3% and in group B male 67% and female 33 % [Table 2] which was comparable (p>0.05). Thus, our groups were comparable. The choice of dosage of clonidine and fentanyl in our comparison was based on few research including by Radhe sharan et al [5]. They compared clonidine + ropivacaine and fentanyl + ropivacaine as adjuvant in lower- abdominal operations. They discovered that although both groups were effective in achieving hemodynamic stabilization and surgical anesthetic, the ropivacaine plus clonidine group outperformed the ropivacaine plus fentanyl group in view of longer postoperative analgesia duration, longer sensory block duration, and fewer doses of rescue analgesia needed. The time duration between the injection of spinal anesthesia at L2-L3 interspace and loss of feeling to a pin prick at Dermatome level T10 (Dermatome for surgical readiness) is known as the onset period of sensory block. The group A and B had mean onsets of sensory blockage of 6.93 ± 1.64 and 6.20 ± 1.42, respectively, with a statistically non-significant p value of 0.069 [Graph 3]. Time taken in between the sensory blockage of T 10 dermatome and the time till the sensory block regressions to S1 was the mean duration of the sensory blockade. The mean length of blockade differed significantly between groups A and B (p value 0.045), indicating that the Ropivacaine with Clonidine group experienced a longer period of the sensory block. The mean duration for A group was 194.4 ± 18.62, whereas B group had 203.87 ± 17.15 as shown in table 4. This outcome is supported by other studies done [6,4,7]. In studies done [8] on the effects of ropivacaine mixed with different dosages of clonidine in spinal anesthesia. According to the studies ropivacaine and clonidine can be used to provide a intense and prolonged sensory and motor block during surgical procedures. But sedation, bradycardia, and hypotension need to be closely watched. The time duration from delivery of spinal anesthesia to the motor blockade with a modified bromage score of three is known as the motor blockade onset. The onset of motor blockage does not differ much between two of the groups (p value 0.132). It was 10.13 ± 2.03 in the group A and 9.40 ± 1.67 in the group B. The research done [8-10], are supportive of our research. In our trial, we restricted the clonidine dose to 30μg in order to minimize the negativeeffects. The time duration between the beginning of the motor blockade (measured by a modified bromage score of 3) and the regression of entire motor blockade (measured by a modified bromage score of 0) is called as motor block duration. In comparison to A - group, blockage was substantially high in B - group (p - value is 0.046). It was 167.20 ± 19.9 mins in A group and 175.67 ± 14.96 mins in B group, [Table 4]. The research conducted [8,9,11] support our findings. Contrary to our findings, [12] discovered in their research that sensory and motor blockage properties of intrathecal 30 μg clonidine were similar to those of 25 μg fentanyl. Unlike our research, [5] found that intrathecal fentanyl 30 μg was more effective in knee arthroscopy than intrathecal clonidine 15 μg. This could be the outcome of administering a low dose of intrathecal clonidine plus a large dose of intrathecal fentanyl. Group B experienced a longer mean time for first rescue analgesia. It was 219.47 ± 20.43 in group A and 237.73 ± 18.37 in group B. Additionally, it was determined [2,13] that improving post-operative analgesia and lowering the requirement for rescue analgesics are achieved by intrathecally adding opioid. This outcome were also supported by research done [14,5,6]  study, which indicated that intrathecal 30 μg fentanyl was better than intrathecal 15 μg clonidine in knee arthroscopy, were not supported by our research. This might be the result of using intrathecally high dose fentanyl and a low dose clonidine.

 

LIMITATIONS OF THE STUDIES

We didn’t standardized the drug doses based on age, height and weight.

CONCLUSION

This study contributes significant findings to the effectiveness of clonidine as a adjuvant with ropivacaine in spinal anesthesia for lower body procedures.The key finding of the study are the onset of sensory and motor blockade was similar with both the groups. The duration of sensory and motor blockade was prolonged in ropivacaine plus clonidine group and this combination was found to be better suited for elective infraumbilical surgeries. The slower regression of the block in ropivacaine plus clonidine group, made it a better choice for longer duration lower limb surgery. The mean time for first rescue analgesia was more in ropivacaine plus clonidine group as compared to ropivacaine plus fentanyl, reducing the analgesic requirement in the early post-operative period.

 

AKNOWLEDGEMENT

The authors would like to thanks each and every participant for taking part in this studies

REFERENCES
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  4. Niemi L.Effects of intrathecal clonidine on duration of bupivacaine spinal anaesthesia, haemodynamics, and postoperative analgesia in patients undergoing knee arthroscopy.Acta Anaesthesiol Scand. 1994 Oct;38(7):724-8. doi: 10.1111/j.1399-6576.1994.tb03985.x.PMID: 7839785 Clinical Trial.

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  6. Chhabra AR, Jagtap SR, Dawoodi SF. Comparison of clonidine versus fentanyl as an adjuvant to intrathecal ropivacaine for major lower limb surgeries: A randomized double blind prospective study. Indian J Pain. 2013;27:170–4. 

  7. M De Kock P GautierL FanardJ L HodyP Lavand' homme Intrathecal ropivacaine and clonidine for ambulatory knee arthroscopy: a dose-response study. Anesthesiology 2001 Apr;94(4):574-8. doi: 10.1097/00000542-200104000-00008. PMID: 11379675

  8. Gonul Sagiroglu Tamer Sagiroglu Burhan Meydan.The effects of adding various doses of clonidine to ropivacaine in spinal anesthesia. Eurasian J Med .2009 Dec;41(3):149-53. MID: 25610092 PMCID: PMC4261276

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