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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 9  |  Issue : 3  |  Page : 351-355

Comparative study of epidural fentanyl with bupivacaine and epidural tramadol with bupivacaine for postoperative pain management in orthopedic lower limb surgeries


Department of Anesthesiology, Konaseema Institute of Medical Sciences and Research Foundation (KIMS & RF), Amalapuram 533201, Andhra Pradesh, India

Date of Submission17-Mar-2022
Date of Acceptance08-Jul-2022
Date of Web Publication29-Sep-2022

Correspondence Address:
Dr. Lakshmi V S Kutikuppala
Department of Anesthesiology, Konaseema Institute of Medical Sciences and Research Foundation (KIMS & RF), Amalapuram 533201, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mgmj.mgmj_35_22

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  Abstract 

Introduction: Pain is a complex subjective sensation that is difficult to quantify in a repeatable manner. Surgical pain is observed to be more intense post-surgery and then fades in the next 24 h. Epidural anesthesia/analgesia is the most widely used technique for lower limb surgeries because of its good sensory and motor block property, reduces stress response, and maintains sufficient spontaneous respiration and hemodynamic stability. Materials and Methods: The study looked at 100 individuals between the ages of 20 and 60 who underwent elective lower limb surgery and were classified as ASA I and II. The patients were split into two 50-person groups. The adverse effects of nausea, vomiting, respiratory depression, urine retention, and pruritus, as well as the quality and duration of postoperative analgesia, were investigated. The patient was monitored for 48 h after surgery. Results: A total of 100 patients were included in the study, where the least age of the patient was 19 years and the greatest age was 75 years. In group T, maximum patients belong to the age group of 26–35 years, whereas in group F maximum patients belong to the age group of 36–45years. In group T, 41 (82%) were males and 9 (18%) were females. In group F, 37 (74%) were males and 13 (26%) were females. Conclusion: Our findings show that epidural tramadol and epidural fentanyl are equally effective, except for fentanyl’s shorter duration of action. Fentanyl also has a moderate sedative effect, which is beneficial in the postoperative period.

Keywords: Bupivacaine, epidural anesthesia, fentanyl, pain, tramadol


How to cite this article:
Rao YV, Nadimpalli HK, Kutikuppala LV. Comparative study of epidural fentanyl with bupivacaine and epidural tramadol with bupivacaine for postoperative pain management in orthopedic lower limb surgeries. MGM J Med Sci 2022;9:351-5

How to cite this URL:
Rao YV, Nadimpalli HK, Kutikuppala LV. Comparative study of epidural fentanyl with bupivacaine and epidural tramadol with bupivacaine for postoperative pain management in orthopedic lower limb surgeries. MGM J Med Sci [serial online] 2022 [cited 2022 Nov 29];9:351-5. Available from: http://www.mgmjms.com/text.asp?2022/9/3/351/357465




  Introduction Top


Pain refers to unpleasant emotional and sensory experience linked to real or tissue damage, and it is characterized in terms of that harm. The management of pain after surgery is crucial in the postoperative care of patients. Aside from psychological damage, the pain has been found to alter the physiology of practically every system in the body, including the cardiovascular, metabolic, and respiratory profiles increasing morbidity.[1]

Adequate pain management remains one of the society’s most essential and pressing challenges, as well as among the scientific community and healthcare professionals. Following most surgical operations, pain is a common complaint among most people. Patients with these disadvantages are frequently unable to breathe properly or cough effectively due to pain.[2] They might not be able to move about enough to meet their own basic needs. They may suffer feelings of helplessness, fear, anxiety, low mood, and a loss of self-control as a result of this.[3]

To alleviate postoperative pain, various techniques have been tested. Various medications have been explored as epidural analgesia. In a vast number of trials, epidural opioids have been utilized to relieve pain postoperatively. Morphine and other epidural narcotics cause side effects including respiratory depression, drug dependency, and itching, and they should not be administered to elderly individuals. Tramadol is an opioid agonist and a blocker of monoamine reuptake and is a safe and effective analgesic throughout the surgery. It has about a fifth to a tenth of the analgesic effect of morphine. However, it can cause nausea, vomiting, urine retention, and hypotension.[4]

Fentanyl is a synthetic opioid derived from phenylpiperidine. To alleviate postoperative pain, it is 75–125 times more effective than morphine. It has a cap on respiratory depression, lowers the risk of addiction, and reduces pruritus, vomiting, urine retention, and nausea. However, it provides sedation that is comparably greater than morphine, which is desirable during the period after surgery. Epidural analgesia is one of the most widely used procedures for the surgeries of the lower limb because it gives good motor as well as a sensory block with contracted bowels while maintaining adequate spontaneous respiration, hemodynamic stability, and the ability to administer doses of analgesia during the postoperative period through an indwelling catheter.[5]

The opioid receptor discovery in the spinal cord and sequential development of epidural and intrathecal opioid administration techniques have paved the way to a new horizon in perioperative pain management and gained significance over the last three decades.[6] Epidural analgesia has been shown in numerous trials to reduce stress responses. This impact appears to be highest when epidural analgesia is prolonged after surgery, and it outperforms standard intravenous and intramuscular injection opioids. Because of morphine’s hydrophilic nature and rostral distribution, epidural opioids have their own set of side effects, the most hazardous of which are delayed respiratory depression, nausea, and vomiting.[7] Tramadol, an opioid agonist and monoamine reuptake blocker, is a safe and effective perioperative analgesia. It has about a fifth to a tenth of the analgesic effect of morphine. However, it can cause nausea, vomiting, urine retention, and hypotension.[8] Buprenorphine, which is 30 times more potent than morphine and is an agonist–antagonist with a lipid solubility of around five times that of morphine, has been used epidurally for perioperative analgesia and has been connected to a low incidence of respiratory depression due to the lack of rostral spread, but it has also been associated with urinary retention.[9] In the last three decades, the arrival of a new synthetic lipophilic opioid, fentanyl, which has a shorter duration of action and time of start than pethidine and morphine, has revolutionized its use.[10],[11] As a result, this clinical trial comparing epidural fentanyl with epidural tramadol and epidural bupivacaine in lower limb procedures is being conducted to assess their practicality, efficacy, and side effects as effective analgesics in postoperative pain treatment.


  Materials and methods Top


After receiving clearance from the Institute’s Ethics Committee with a reference number KIMS/2019/029, the suggested study was carried out in a tertiary care hospital setting. A randomized prospective study was done on 100 adult individuals (ASA I and II) receiving elective orthopedic surgery under epidural block during the 2019–20 academic period over 1 year. A total of 100 individuals undergoing various lower limb procedures were chosen at random. A computer-generated random number table was used for randomization. Patients were placed into two 50-person groups. All of the patients were ASA I and ASA II, and they ranged in age from 21 to 60. During their post-operative time from the end of the surgery, group F received an injection of fentanyl 2 µg/kg plus 0.1% bupivacaine (total 10 mL) epidurally, whereas group T received the injection of tramadol 1 mg/kg plus 0.1% bupivacaine (total 10 mL) epidurally. Routine tests were performed on all of the patients. The study comprised participants aged 20–60 years with ASA physical status I and II who were scheduled for elective lower limb orthopedic procedures. Patients with spinal abnormalities, neurological deficits, bleeding and clotting issues, local sepsis near the epidural needle insertion site, and those who refused to participate in the study were excluded. The total procedure was detailed to the patients, who were advised to tell the doctor if he/she felt any pain after surgery. Patients were also taught how to use the visual analog scale (VAS) and how to represent their pain on the scale. The patient’s written consent was obtained.

An intravenous infusion was started with an 18 G needle in the operating room, with all resuscitation equipment and precautions, and the patients were preloaded with 500 mL of Ringer lactate solution and placed in a lateral/sitting position with a little pillow for the head and shoulder. Epidural space was found using an 18 G Tuohy needle at L2–L3 space by loss of resistance using an air injection technique, and an 18 G epidural catheter was threaded into the epidural space for 4–5 cm length in the cephalad direction and appropriately fixed. As a test dosage, 3 mL of 2% lignocaine with adrenaline 1:2,000,000 was injected through the catheter and looked for any intravascular or intrathecal injections. About 0.5% bupivacaine was given intrathecally in the L4–L5 area after the catheter insertion was confirmed. The medicine dosage was determined by the patient, the type of surgery, and the length of the procedure. During the intra-operative time, no narcotics were given. The drug was given at a rate of about 1 mL/s, and the height of analgesia was evaluated using the pinprick test. When two identical dermatomes on each side were insensitive, the spread was judged complete.

A single dosage of tramadol 1 mg/kg or 2 µg/kg of fentanyl in 10 mL of 0.1% bupivacaine was given into the epidural catheter at the end of the operation and was repeated every 6 h for the next 48 h. The epidural catheter was withdrawn after 48 h. The patient’s vital statistics were monitored after each epidural top-up. When a patient complained of discomfort, they were shown the VAS and asked to rate their pain on a scale of 1–10. Through the epidural catheter, a single dose of tramadol (1 mg/kg) or fentanyl (2 µg/kg) was administered in 10 mL of 0.1% bupivacaine. When the patient’s pain relief was assessed, the requirement for rescue analgesia was determined.

Pain levels greater than VAS 4 on the scale were observed. Pruritus allergic response, nausea, respiratory depression, vomiting, and hypotension were all reported as side effects. The nursing team was told to keep track of the time of rescue analgesia, after which the patients were transferred to the postoperative ward.

Statistical analysis

The mean, standard deviation, number, and percentages are used to present the descriptive data. The IBM SPSS Statistics for Windows, Version 24.0, was used to analyze continuous data using Student’s t-test (IBM Corp., Armonk, NY, USA). A P-value of less than 0.05 was considered statistically significant.


  Results Top


A total of 100 patients were considered for this study, in which the least age of the patient was 19 years and the greatest age was 75 years. In group T, maximum patients are from the age group of 26–35 years, whereas in group F, the majority of patients belonged to the age group of 36–45 years [Table 1]. In group T, 39 (78%) patients belonged to ASA grade I and 11 (22%) patients belonged to ASA grade II. In group F, 33 (66%) patients belonged to ASA grade I and 17 patients belonged to ASA Grade II [Table 2]. In group T, 52% of the patients had nausea, 12% had vomiting, 10% had pruritus, and 2% had urinary retention as a side effect, but in group F only 2% had nausea and no other complications were seen [Table 3]. In group T, the maximum number of patients took rescue analgesia at the 22nd hour [Table 4]. In group F, the maximum number of patients took rescue analgesia at the 11th hour [Table 5]. In group T, all patients took rescue analgesia one time except one patient who took it two times. In group F, 33 patients took the rescue analgesia two times and 17 patients took the rescue analgesia three times in the first 24 h. A maximum number of rescue analgesia (117) were taken in group F in the first 24 h [Table 6].
Table 1: Age distribution of study participants

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Table 2: Distribution of study participants according to ASA grading

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Table 3: Side effects observed among the study participants

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Table 4: Rescue analgesia for group T

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Table 5: Rescue analgesia for group F

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Table 6: Rescue analgesia in first 24 h

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  Discussion Top


The management of postoperative pain remains a significant challenge for anesthetists, even though despite all of the attempts made to mold the intraoperative phase painless and free from stress, the patient is left to fend for himself during the post-operative period. Both humanitarian and therapeutic motives necessitate pain relief. In the post-operative phase, uncontrolled pain might have negative physiological consequences. Tramadol, which is an opioid agonist and monoamine reuptake blocker, has been widely utilized as an analgesic during the perioperative period. It has analgesic effectiveness of one-fifth to one-tenth that of morphine and has no respiratory depression. However, studies have indicated that at doses of 100 mg or more, it might cause nausea, vomiting, and hypotension.[12]

Fentanyl is a synthetic opioid agonist derived from phenylpiperidine. It is 75–125 times more effective than morphine and has been used successfully in Western countries to manage pain postoperatively since its introduction during the 1970s. Fentanyl has a dose-related ceiling effect on respiratory depression and has fewer adverse effects including nausea, vomiting, and itching when given epidurally, but it generates drowsiness, which is desirable during the post-operative period.[13],[14]

Analgesic quality was assessed when the rescue analgesia was given to the patient. The quality of analgesia is almost the same in both groups, but the duration of analgesia is shorter in group F. In group T, the maximum VAS score (mean ± SD) was 6.24 ± 1.55 at 18th hour and the minimum VAS score (mean ± SD) was 4 ± 0.2 at 48th hour. In group F, the maximum VAS score (mean ±SD) was 7.22 ± 0.81 at the 12th hour and the minimum VAS score (mean ± SD) was 4.4 ± 0.5 at the 48th hour. P-value was highly significant on the 12th, 24th, 30th, 36th, and 48th hours. In group T, maximum patients took rescue analgesia at the 22nd hour. In group F, maximum patients took rescue analgesia at the 11th hour. In group T, all patients took rescue analgesia one time except one patient who took it two times. In group F, 33 patients were taken two times and 17 patients were taken three times. Delilkan and Vijayan[15] in their study noted that the quality of analgesia was significantly better with 100 mg tramadol at 3, 12, and 24 h when compared with tramadol 50 mg or bupivacaine 0.25%. Rostaing et al.[16] in their study with epidural fentanyl 100 µg recorded the duration of action as 250 ± 64 min, and the maximum reduction in VAS score ranged from 57% to 100%. All patients had a slight but significant decrease in blood pressure and respiratory rate.

A study by Lee et al.[17] assessed the postoperative relief of pain using the continuous infusion of epidural fentanyl in two separate dosages for the upper abdominal and thoracic surgeries. Those in group A were given 1.5 µg/kg fentanyl as the initial dose and maintenance dose was 1 and 0.5 µg/kg/h, respectively. The patient was assessed hourly using a VAS score from 0 to 10. It was found that the analgesic effect was apparent to be better in group A, and pain relief was satisfactory in both groups. Lytle et al.[18] studied continuous epidural fentanyl for postoperative analgesia using a concentration of 5 µg/mL of fentanyl. The average rate of infusion was 60 µg/h. The data showed that epidural fentanyl gives a good-to-excellent relief of pain with minimal side effects in orthopedic surgeries.

In our study, 52% had nausea, 12% had vomiting, 10% had pruritus, and 2% had urinary retention as a side effect in group T, whereas in group F, only 2% had nausea and no other complications were seen. The difference was statistically significant by the χ2 test (P < 0.05). Delilkan and Vijayan[15] in their study noted more incidence of nausea and vomiting in the group receiving epidural tramadol 100 mg compared with epidural tramadol 50 mg. A study by Setti et al.[19] found almost 80% pain relief with a dose of 100 µg epidural fentanyl with minimal pruritus and drowsiness requiring no treatment. White et al.[20] in their study compared pruritus, nausea, and respiratory effects over a 48‐h duration of continuous epidural morphine and fentanyl. Evaluation of the side effects by the VAS was considered to be present when the score was higher. In the fentanyl group, respiratory effects were present and nausea was present only in the first few hours.


  Conclusion Top


In comparison to epidural tramadol, epidural fentanyl gives a faster but shorter period of analgesia, according to this study. Epidural fentanyl caused fewer side effects such as nausea and vomiting, but milder drowsiness. According to our findings, both epidural tramadol and epidural fentanyl are equally effective, except for fentanyl’s shorter duration of action. Fentanyl also has a moderate sedative effect, which is beneficial during the postoperative period.

Ethical consideration

Institutional Ethics Committee, Konaseema Institute of Medical Sciences and Research Foundation, Amalapuram, Andhra Pradesh, India has approved undertaking the proposed study on “Comparative study of epidural fentanyl with bupivacaine and epidural tramadol with bupivacaine for postoperative pain management in orthopedic lower limb surgeries” vide their letter no. KIMS/2019/029 dated April 26, 2019.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Gupta R, Kaur S, Singh S, Aujla KS A comparison of epidural butorphanol and tramadol for postoperative analgesia using CSEA technique. J Anaesthesiol Clin Pharmacol 2011;27:35-8.  Back to cited text no. 4
    
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11.
Gürses E, Sungurtekin H, Tomatir E, Balci C, Gönüllü M The addition of droperidol or clonidine to epidural tramadol shortens onset time and increases duration of postoperative analgesia. Can J Anaesth 2003;50:147-52.  Back to cited text no. 11
    
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Dhale S, Shelgaonkar V, Akulwar VV A comparative study of epidural bupivacaine and epidural bupivacaine with fentanyl for perioperative analgesia. Indian J Anaesth 2000;7:44-55.  Back to cited text no. 13
    
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Pokharel K, Rahman TR, Singh SN, Bhattarai B, Basnet N, Khaniya S The efficacy and safety of low dose epidural butorphanol on postoperative analgesia following cesarean delivery. J Nepal Med Assoc 2008;47:57-61.  Back to cited text no. 14
    
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Delilkan AE, Vijayan R Epidural tramadol for postoperative pain relief. Anaesthesia 1993;48:328-31.  Back to cited text no. 15
    
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Rostaing S, Bonnet F, Levron JC, Vodinh J, Pluskwa F, Saada M Effect of epidural clonidine on analgesia and pharmacokinetics of epidural fentanyl in postoperative patients. Anesthesiology 1991;75:420-5.  Back to cited text no. 16
    
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Lee MC, Lin YF, Yang YD, Woang KY, Poon KS, Chang WK, et al. Continuous epidural fentanyl in postoperative pain control—A comparison of two different dosages. Ma Zuixue Zhi 1989;27:235-40.  Back to cited text no. 17
    
18.
Lytle SA, Goldsmith DM, Neuendorf TL Combining epidural fentanyl and lidocaine for postoperative pain. J Am Osteopath Assoc 1991;91:1209-12, 21-22.  Back to cited text no. 18
    
19.
Setti T, Sanfilippo F, Leykin Y Transdermal buprenorphine for postoperative pain control in gynecological surgery: A prospective randomized study. Curr Med Res Opin 2012;28:1597-608.  Back to cited text no. 19
    
20.
White MJ, Berghausen EJ, Dumont SW, Tsueda K, Schroeder JA, Vogel RL, et al. Side effects during continuous epidural infusion of morphine and fentanyl. Can J Anaesth 1992;39:576-82.  Back to cited text no. 20
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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