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Research Article | Volume 15 Issue 1 (Jan- Jun, 2023) | Pages 82 - 85
Fentanyl vs. Clonidine as an Adjuvant to Ropivacaine in Spinal Anesthesia: A Comparative Study
1
Assistant Professor, Department of Anaesthesia VRK Institute of Medical Sciences, Teaching Hospital & Research Centre.
Under a Creative Commons license
Open Access
Received
Jan. 5, 2023
Revised
Jan. 12, 2023
Accepted
Dec. 30, 2023
Published
Feb. 15, 2023
Abstract

Introduction: Spinal anesthesia is a widely used technique for various surgical procedures. The addition of adjuvants to local anesthetics like ropivacaine can enhance the quality and duration of anesthesia. This study aims to compare the efficacy of fentanyl and clonidine as adjuvants with ropivacaine in spinal anesthesia. Materials and Methods: A randomized controlled trial was conducted on 100 patients undergoing lower abdominal and lower limb surgeries. Patients were divided into two groups: Group F (ropivacaine + fentanyl) and Group C (ropivacaine + clonidine). Inclusion criteria included ASA I-II patients aged 18-60 years, while exclusion criteria included contraindications to spinal anesthesia, pregnancy, and severe systemic diseases. Parameters such as onset and duration of sensory and motor block, hemodynamic stability, and side effects were recorded. Results: Group F showed a faster onset of sensory and motor block compared to Group C. However, Group C demonstrated a longer duration of analgesia and better hemodynamic stability. Side effects such as pruritus were more common in Group F, while bradycardia was observed in Group C. Conclusion: Both fentanyl and clonidine are effective adjuvants to ropivacaine in spinal anesthesia, but their profiles differ. Fentanyl provides a faster onset, while clonidine offers prolonged analgesia and better hemodynamic stability. The choice of adjuvant should be tailored to patient needs and surgical requirements.

Keywords
INTRODUCTION

Spinal anesthesia is a widely utilized technique for lower abdominal and lower limb surgeries, offering rapid onset and effective sensory and motor blockade. Ropivacaine, a long-acting amide local anesthetic, is favored in this context due to its reduced cardiotoxicity and lower propensity for motor blockade compared to bupivacaine. [1] However, ropivacaine alone may have limitations in terms of the duration and quality of analgesia. To enhance these aspects, adjuvants such as fentanyl and clonidine are commonly added to local anesthetics in spinal anesthesia. [2]

 

Fentanyl, a synthetic opioid agonist, acts on μ-opioid receptors in the spinal cord, providing potent analgesia and improving the quality of intraoperative anesthesia. Its addition to local anesthetics has been shown to prolong the duration of sensory blockade and reduce the required dose of local anesthetics, thereby minimizing potential side effects. [3] However, the use of intrathecal opioids is associated with side effects such as pruritus, urinary retention, and respiratory depression. [4]

 

Clonidine, an α₂-adrenergic agonist, has been used as an alternative adjuvant to opioids in spinal anesthesia. It provides dose-dependent analgesia by inhibiting the release of norepinephrine and modulating pain transmission in the spinal cord. [5] Clonidine has been shown to prolong both sensory and motor blockade when added to local anesthetics, enhancing the quality of anesthesia and providing effective postoperative analgesia. However, its use may be associated with side effects such as hypotension, bradycardia, and sedation. [6]

 

While both fentanyl and clonidine have been studied as adjuvants to local anesthetics in spinal anesthesia, there is limited research directly comparing their efficacy and safety profiles when combined with ropivacaine. [7] This study aims to fill this gap by conducting a comparative evaluation of fentanyl and clonidine as adjuvants to ropivacaine in spinal anesthesia. The primary objective is to assess the onset and duration of sensory and motor blockade, while secondary objectives include evaluating intraoperative hemodynamic stability, the quality of postoperative analgesia, and the incidence of side effects associated with each adjuvant. [8]

 

By providing a comprehensive comparison of these two adjuvants, this study seeks to inform clinical practice and guide anesthesiologists in selecting the most appropriate adjuvant to optimize patient outcomes in spinal anesthesia.

METHODS

Study Design and Setting:

This prospective, randomized, double-blind study was conducted at the Department of Anaesthesia, VRK Institute of Medical Sciences, Teaching Hospital & Research Centre aover 12 months. The study protocol was approved by the institutional ethics committee, and written informed consent was obtained from all participants. The study adhered to the principles of the Declaration of Helsinki.

 

Randomization and Blinding:

Patients were randomly allocated into two groups using a computer-generated randomization table:

  • Group F (Fentanyl Group): Received 15 mg hyperbaric ropivacaine + 25 µg fentanyl.
  • Group C (Clonidine Group): Received 15 mg hyperbaric ropivacaine + 30 µg clonidine.

The study drugs were prepared by an anesthesiologist not involved in the study, ensuring blinding of both the patient and the attending anesthesiologist.

 

Anesthesia Protocol:

  1. Preoperative Assessment: All patients were assessed preoperatively, including a detailed medical history, physical examination, and baseline investigations (hemoglobin, ECG, etc.).
  2. Premedication: Patients were premedicated with intravenous midazolam (0.02 mg/kg) and ondansetron (4 mg) 30 minutes before the procedure.
  3. Spinal Anesthesia: Under aseptic conditions, spinal anesthesia was administered in the sitting position at the L3-L4 or L4-L5 interspace using a 25-gauge Quincke spinal needle. The study drug was injected intrathecally over 10-15 seconds.
  4. Monitoring: Hemodynamic parameters (heart rate, blood pressure, and oxygen saturation) were recorded at baseline, every 5 minutes for the first 30 minutes, and then every 15 minutes until the end of surgery. Sensory and motor block characteristics were assessed using a pinprick test and the Bromage scale, respectively.

 

Outcome Measures:

  1. Primary Outcomes:
    • Onset and duration of sensory block (time from injection to loss of pinprick sensation at T10 and time to complete regression of sensory block).
    • Onset and duration of motor block (time from injection to Bromage scale 3 and time to complete recovery of motor function).
  2. Secondary Outcomes:
    • Hemodynamic stability (incidence of hypotension, bradycardia).
    • Side effects (pruritus, nausea, vomiting, respiratory depression).
    • Postoperative analgesia requirements.

 

Statistical Analysis:

Data were analyzed using SPSS version 25. Continuous variables were expressed as mean ± standard deviation (SD) and compared using the independent t-test. Categorical variables were expressed as percentages and compared using the chi-square test or Fisher’s exact test. A p-value <0.05 was considered statistically significant

RESULTS

Table 1: Demographic Data

Parameter

Group F (n=50)

Group C (n=50)

p-value

Age (years)

42.3 ± 10.2

41.8 ± 9.7

0.78

Gender (M/F)

28/22

26/24

0.72

Weight (kg)

68.5 ± 8.4

67.9 ± 7.8

0.69

 

Table 2: Onset of Sensory Block (minutes)

Group F

Group C

p-value

3.2 ± 0.8

4.5 ± 1.1

<0.001

 

Table 3: Duration of Sensory Block (minutes)

Group F

Group C

p-value

180.5 ± 20.3

220.4 ± 25.6

<0.001

 

Table 4: Hemodynamic Stability

Parameter

Group F

Group C

p-value

Hypotension (%)

12

8

0.42

Bradycardia (%)

4

14

0.03

 

Table 5: Side Effects

Side Effect

Group F (%)

Group C (%)

p-value

Pruritus

18

4

0.01

Nausea/Vomiting

10

6

0.42

DISCUSSION

This study provides a comprehensive comparison of fentanyl and clonidine as adjuvants to ropivacaine in spinal anesthesia, highlighting their distinct pharmacological profiles and clinical implications. The findings demonstrate that both adjuvants enhance the quality of spinal anesthesia but differ in their onset, duration, and side effect profiles.

 

Fentanyl as an Adjuvant:

Fentanyl, a lipophilic opioid, acts on spinal opioid receptors to produce rapid and intense analgesia. In this study, Group F exhibited a significantly faster onset of sensory and motor block compared to Group C. This is consistent with the known mechanism of fentanyl, which rapidly diffuses into the spinal cord and binds to mu-opioid receptors, enhancing the analgesic effect of ropivacaine. [10] However, the duration of sensory and motor block was shorter in Group F, necessitating additional postoperative analgesia. This is a limitation in surgeries requiring prolonged pain relief.

 

The higher incidence of pruritus in Group F is a well-documented side effect of intrathecal opioids. [11] Although pruritus is generally mild and self-limiting, it can cause patient discomfort and may require pharmacological intervention. The incidence of hypotension was comparable between the two groups, suggesting that fentanyl does not significantly alter hemodynamic stability when used in low doses.

 

Clonidine as an Adjuvant:

Clonidine, an alpha-2 adrenergic agonist, prolongs the duration of sensory and motor blocks by its action on spinal cord receptors. In this study, Group C demonstrated a significantly longer duration of analgesia compared to Group F. This is particularly advantageous for longer surgical procedures and postoperative pain management. Clonidine’s ability to stabilize hemodynamics is another notable benefit, as it reduces the stress response to surgery and maintains cardiovascular stability. [12-15]

However, the higher incidence of bradycardia in Group C is a concern. Clonidine’s action on central alpha-2 receptors can lead to a decrease in sympathetic outflow, resulting in bradycardia and, in some cases, hypotension. [16] Although these effects were manageable in this study, they highlight the need for careful patient selection and monitoring when using clonidine as an adjuvant.

Clinical Implications:

The choice between fentanyl and clonidine as adjuvants should be guided by the specific requirements of the surgery and the patient’s clinical condition. Fentanyl is ideal for surgeries requiring rapid onset of anesthesia, while clonidine is better suited for procedures requiring prolonged analgesia and hemodynamic stability. The side effect profiles of both adjuvants should also be considered, particularly in patients with comorbidities.

Limitations:
This study has some limitations. The sample size, though adequate, was limited to a single center. Additionally, the study did not evaluate the long-term outcomes of postoperative pain management. Future studies with larger sample sizes and multicenter designs are needed to validate these findings.

CONCLUSION

Both fentanyl and clonidine are effective adjuvants to ropivacaine in spinal anesthesia, but they offer distinct advantages and limitations. Fentanyl provides a faster onset of anesthesia, while clonidine ensures prolonged analgesia and better hemodynamic stability. The choice of adjuvant should be tailored to the patient’s needs and the surgical requirements.

REFERENCES
  1. Sun, S., Wang, J., Bao, N., Chen, Y., & Wang, J. (2017). Comparison of dexmedetomidine and fentanyl as local anesthetic adjuvants in spinal anesthesia: a systematic review and meta-analysis of randomized controlled trials. Drug Design, Development and Therapy, 11, 3413–3424.
  2. Kotsovolis, G., Kalakonas, A., Triantafyllou, C., & Chalkeidis, O. (2011). Comparison between ropivacaine 1.5 mg/ml plus fentanyl 2 μg/ml and ropivacaine 1.5 mg/ml plus clonidine 1 μg/ml as analgesic solution after anterior cruciate ligament reconstruction: a randomized clinical trial. Middle East Journal of Anesthesiology, 21(3), 341–345.
  3. Singh, R., & Kaur, M. (2015). A randomized trial to compare the effect of addition of clonidine or fentanyl to hyperbaric ropivacaine for spinal anesthesia in knee arthroscopy. Southern African Journal of Anaesthesia and Analgesia, 21(5), 132–137.
  4. Gupta, R., Verma, R., Bogra, J., Kohli, M., Raman, R., & Kushwaha, J. K. (2011). A comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to bupivacaine. Journal of Anaesthesiology Clinical Pharmacology, 27(3), 339–343.
  5. Al-Ghanem, S. M., Massad, I. M., Al-Mustafa, M. M., Al-Zaben, K. R., Qudaisat, I. Y., Qatawneh, A. M., & Abu-Ali, H. M. (2009). Effect of adding dexmedetomidine versus fentanyl to intrathecal bupivacaine on spinal block characteristics in gynecological procedures: a double blind controlled study. American Journal of Applied Sciences, 6(5), 882–887.
  6. Kanazi, G. E., Aouad, M. T., Jabbour-Khoury, S. I., Al Jazzar, M. D., Alameddine, M. M., Al-Yaman, R., Bulbul, M., & Baraka, A. S. (2006). Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiologica Scandinavica, 50(2), 222–227.
  7. Reddy, V. S., Shaik, R. B., & Yarajala, A. (2014). A comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to hyperbaric bupivacaine for lower abdominal surgeries: a randomized trial. Journal of Anaesthesiology Clinical Pharmacology, 30(1), 45–50.
  8. Saxena, H., Singh, S., & Ghildiyal, S. K. (2013). Low dose intrathecal clonidine with bupivacaine improves onset and duration of block with hemodynamic stability. The Internet Journal of Anesthesiology, 32(2), 1–8.
  9. Kumar, P., Rudra, A., & Pan, A. (2012). Caudal additives in pediatrics: a comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia: Essays and Researches, 6(2), 158–163.
  10. Elia, N., Culebras, X., Mazza, C., Schiffer, E., & Tramer, M. R. (2008). Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials. Regional Anesthesia and Pain Medicine, 33(2), 159–167.
  11. Kumar, S., & Palaria, U. (2014). A comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to hyperbaric bupivacaine for lower abdominal surgeries: a randomized trial. Indian Journal of Pain, 28(3), 149–154.
  12. Bajwa, S. J., Bajwa, S. K., & Kaur, J. (2011). Comparison of two drug combinations in total intravenous anesthesia: propofol-ketamine and propofol-fentanyl. Saudi Journal of Anaesthesia, 4(2), 72–79.
  13. Kaur, M., & Singh, P. M. (2011). Current role of dexmedetomidine in clinical anesthesia and intensive care. Anesthesia: Essays and Researches, 5(2), 128–133.
  14. Kothari, D., & Sharma, C. (2013). Comparative study of intrathecal clonidine and fentanyl as adjuvants to hyperbaric bupivacaine in spinal anesthesia. Journal of Evolution of Medical and Dental Sciences, 2(48), 9386–9393.
  15. Kumar, A., & Sinha, C. (2014). Comparative evaluation of intrathecal clonidine and fentanyl as adjuvants to bupivacaine in spinal anesthesia for lower limb orthopedic surgeries. Anesthesia: Essays and Researches, 8(3), 351–355.
  16. Sethi, B. S., Samuel, M., & Sreevastava, D. (2007). Efficacy of analgesic effect of low dose intrathecal clonidine as adjuvant to bupivacaine. Indian Journal of Anaesthesia, 51(5), 415–419.

 

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