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ORIGINAL ARTICLE
Year : 2021  |  Volume : 54  |  Issue : 1  |  Page : 1-6

The hemodynamic and analgesic efficacy of subcutaneous dexmedetomidine versus Marcaine 0.5% in postoperative pain management following herniorrhaphy


1 Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran
2 Department of Surgery, Arak University of Medical Sciences, Arak, Iran
3 Student Research Center, Arak University of Medical Sciences, Arak, Iran

Date of Submission06-Jun-2020
Date of Decision06-Jul-2020
Date of Acceptance17-Aug-2020
Date of Web Publication22-Jan-2021

Correspondence Address:
Hesameddin Modir
Departments of Surgery, Arak University of Medical Sciences, Arak
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/fjs.fjs_93_20

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  Abstract 


Background: This study addressed the comparative hemodynamic and analgesic effects of subcutaneous dexmedetomidine versus Marcaine 0.5% on herniorrhaphy scheduled patients, as well as postoperative pain management.
Materials and Methods: A double-blind trial was conducted in three groups of patients (n = 120) scheduled for herniorrhaphy. The study groups were (i) Marcaine + dexmedetomidine (MAR-DEX) group, receiving Marcaine 0.5% (5 mg) + dexmedetomidine (1 mcg/kg), (ii) MAR group, Marcaine 0.5% (5 mg), and (iii) PBO group, placebo, subcutaneously. Vital signs (blood pressure/heart rate/SaO2), as well as pain scores (using the Visual Analog Scale) at recovery and certain time points (1, 2, 4, 6, 12, and 24 h postoperatively) were measured. Moreover, the overall opioid administered postoperatively and the side effects were recorded. Data were analyzed by SPSS (version 20) software by analysis of variance and repeated measurement tests.
Results: Lower pain score was revealed in the MAR-DEX group and higher one in the PBO group (P < 0.001), whereas the lowest opioid use was observed in the MAR-DEX group (P < 0.001).
Conclusion: Adding dexmedetomidine had benefits of relieving pain and reducing opioid use without any side effects.

Keywords: Dexmedetomidine, hemodynamic changes, Marcaine 0.5%, subcutaneous injection


How to cite this article:
Pazoki S, Modir H, Kamali A, Naimi A, Maktubian M, Amini N. The hemodynamic and analgesic efficacy of subcutaneous dexmedetomidine versus Marcaine 0.5% in postoperative pain management following herniorrhaphy. Formos J Surg 2021;54:1-6

How to cite this URL:
Pazoki S, Modir H, Kamali A, Naimi A, Maktubian M, Amini N. The hemodynamic and analgesic efficacy of subcutaneous dexmedetomidine versus Marcaine 0.5% in postoperative pain management following herniorrhaphy. Formos J Surg [serial online] 2021 [cited 2021 Mar 6];54:1-6. Available from: https://www.e-fjs.org/text.asp?2021/54/1/1/307627




  Introduction Top


Postoperative pain management (PPM) remains a key surgical issue, influencing the health-care system and resulting in patients' delayed return to normal conditions, lengthened hospitalization, increased atelectasis, venous thrombosis, and eventually diminished patient satisfaction. Postoperative administrated analgesics help improve patient pain and ergo pulmonary function due to physiotherapy facilitation by him/her. Besides, owing to the early resumption of normal activity, constipation and venous thromboembolic complications are reduced, and subsequently, the period of convalescence is shortened.[1] Opioid analgesics being used as a potent postoperative analgesic are associated with diverse complications, such as dizziness, decreased respiratory function, ileus, nausea, vomiting, itching, and urinary retention.

Method of intermittent intramuscular (IM) or intravenous (IV) or subcutaneous (SC) injections is required to manage perioperative pain to achieve a steady state in which it is always maintained above the minimum effective analgesic concentration. However, inadequate, unpredictable blood concentrations at injection intervals make it difficult to determine the appropriate dosage and to adjust drug dosing to a stable concentration, and then, careful nursing care is needed to avoid injecting large volumes of the drug intravenously, which is associated with a higher incidence of weakness of central nervous system and respiratory problems. In most cases where pain control is achieved using opioids requested by the patient, analgesia is usually not sufficient. Hence, pain medications should be chosen that do not have the above side effects and meanwhile provide a better and long-lasting postoperative analgesia.[2],[3]

Local anesthetics, unlike opioids, are increasingly used for the treatment of surgical pain due to their analgesic properties and lack of harmful effects. If acute pain is not well managed, it can have detrimental effects on various body systems, including inability to clear respiratory secretions, gastrointestinal ileus, increased blood pressure/heart rate (BP/HR), sweating, paleness, prolonged bed rest and thereby increased risk of deep venous thrombosis, and delayed onset of lactation.[4],[5] A variety of treatments available for PPM include systemic analgesia techniques, such as opioids and nonopioids, and regional analgesia.[2],[5] Hence, one highly significant issue after surgery is finding a drug that can provide the patient with the least complications, and also the maximum duration of postoperative analgesia, as well as patient comfort. Various drugs are used to relieve patients' pain, such as opioids and the other nonopioids whose advantages to the opioids include no respiratory depression, no potential for drug abuse, low sedative effect, less nausea, early return of bowel function, and faster recovery, because of which many physicians prefer to use nonopioids.[6],[7] Stimulation of α-2 adrenergic receptor agonists, including dexmedetomidine, in the spinal cord can improve postoperative pain.[8],[9],[10],[11],[12]

Anderson et al. (2017) reported that dexmedetomidine results in longer postoperative analgesia and duration of sensory and motor block with minimal complications. Studies have been conducted and provided strong evidence on the efficiency of adding dexmedetomidine to ropivacaine,[13],[14] among which one on the effect of addition of dexmedetomidine to ropivacaine 0.2% for femoral nerve block reported that adding dexmedetomidine in their patients prolonged the duration of postoperative analgesia and of block.[12] Although many studies did look at the IV and intrathecal (IT) dexmedetomidine separately,[15],[14],[15],[16],[17] no one has been performed on the effect of SC dexmedetomidine in hernia surgery and this apparently can relieve pain, and besides, the method has been increasingly successful due to its benefits, including no injection directly into the vein and no drug delivery to vital organs, thereby reducing complications.[18] On the other hand, systemic effects of high-dose IV dexmedetomidine result in a decreased HR/BP which is highly dangerous for people with heart disease,[19] while this will not occur with SC administration.

Given the positive effect of dexmedetomidine on analgesia and no hemodynamic risks of SC injection (unlike IV and IT injection), hence, this study aimed at exploring the effect of SC dexmedetomidine on hemodynamic changes, opioid use, and postoperative pain in hernia surgery.


  Materials and Methods Top


The study aimed to compare the hemodynamic and analgesic effects of SC dexmedetomidine versus Marcaine 0.5% on hernia surgery patients, as well as PPM. This double-blind trial enrolled 120 patients scheduled for hernia surgery at Valiasr Hospital in Arak, who were randomly allocated into three groups.

The double-blind trial enrolled 120 patients who were scheduled for hernia surgery at Valiasr Hospital in Arak in 2019. The sample size was calculated based on power study 80%, alpha error 5%, and the minimum difference in pain score between control and intervention groups. The minimum calculated sample size for each group was 38 patients. Finally, 120 eligible patients were allocated to each group after obtaining written informed consent and verification of inclusion/exclusion criteria. Block random allocation method was used for randomization, and the block size was 6.

The study protocol was approved by the Ethical Committee of Arak University of Medical Sciences (code: IR.ARAKMU. REC.1397.131) and registered in Iranian Registry Clinical Trail Center. (Iranian Clinical Trial code: IRCT20141209020258N99).

Inclusion criteria

Patients with 18–65 years, ASA Class I and II, undergoing hernia surgery, body mass index (BMI) <30, no history of allergy to medications used, no underlying disease, and no smoking and drug use.

Exclusion criteria

Patient dissatisfaction with participation in the study, refusal to receive SC infusion, and severe hemodynamic changes requiring treatment during surgery and recovery.

Intervention

All eligible patients were hospitalized at least 1 day before surgery and were keep nil per os for 8 h. Before the procedure, we measured and recorded baseline HR and mean arterial pressure (MAP) (by noninvasive BP), as well as SaO2. All individuals were administered crystalloid Ringer's solution (10 mL/kg) on arrival to the operating room and given 2 mg midazolam, 2 μg/kg fentanyl, 5 mg/kg sodium thiopental, and 0.5 mg/kg atracurium to induce general anesthesia intravenously, then followed by endotracheal intubation. After recording baseline vital signs, the patients were split into three groups using a random number table: the first group (Marcaine + dexmedetomidine [MAR-DEX]) versus the second group (MAR) received Marcaine 0.5% (5 mg) and dexmedetomidine (1 mcg/kg) versus Marcaine 0.5% (5 mg), respectively, both diluted in distilled water to make a final volume of 10 mL, while the last individuals (Placebo Group [PBO]) were injected placebo (10 cc normal saline) at the incision site subcutaneously. The SC drugs were also injected under sterile conditions into three groups at the end of the surgery but before the wound dressing.

Measurements

An anesthesia resident recorded MAP, HR, and SaO2 in three groups every 5 min until the end of surgery. The hypotension was defined as a 20% drop in pressure, bradycardia <45 BPM, and SaO2 <92%, whereas any appropriate remedial action was taken and recorded in the event of these complications. A single anesthetist resident recorded pain scores using the Visual Analog Scale (VAS) varied from 0 to 10, at recovery and certain time points (2, 4, 6, 12, and 24 h postoperatively), as followed: 0 represents the lowest and 10, the highest. Subsequently, we recorded the overall opioid administered postoperatively and the administration time.[15] The postoperative use and possible complications were recorded, whereas meperidine 0.5 (mg/kg/IM) was administered, if VAS >5.

All data were measured and recorded by the resident who had not any awareness of the patient groupings as well as patients, to perform a double-blind study. The drugs were prepared by an anesthetist in each group and administered by a surgeon blinded to the drugs used in the syringes, and then, infiltration was performed.

Statistical analysis

Data were analyzed using SPSS version 20 (SPSS Inc., Chicago, IL, USA). Descriptive statistical tests include mean, standard deviation frequency, and percent. Moreover, Chi-square test and analysis of variance (ANOVA) were used to compare three groups, and Tukey's post hoc test was used for two-by-two comparison of groups. In addition, ANOVA for repeated measurement test was used to compare the trend of pain reduction in three groups. P < 0.05 was considered as statistically significant.


  Results Top


The mean age of patients in our study was 45.84 ± 13.45 years, and according to [Table 1], there was no significant difference in mean of age among three groups (P = 0.890). From all, 109 patients (90.8%) were male and 11 patients (9.2%) were female. There was no significant difference among three groups regarding sex distribution (P = 0.670) and BMI (P = 0.587).
Table 1: Comparing the man of age and sex distribution of patients in three studied groups

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Hemodynamic parameters were the same in three groups. Duration of surgery, SaO2, and HR did not statistically significantly differ (P < 0.05). Nevertheless, the results showed no statistically significant differences in mean blood pressure [Figure 1] at all times except 5 min after injection at which it was lower in the MAR-DEX group (P = 0.03). Nevertheless, MBP was lower in the MAR-DEX group than the MAR-only group, 5 min after injection (P = 0.03). The mean of HR is depicted in [Figure 2], and based on ANOVA, there was a significant difference among three groups at injection time (P = 0.007), 5 (P = 0.020), and 10 (P = 0.006) min after injection, but there was no significant difference at induction time and 15 min after injection (P > 0.05). The post hoc analysis showed that two intervention groups were the same in all time (P > 0.05).
Figure 1: Comparison of blood pressure in the three groups

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Figure 2: The mean of heart rate and its trend among the three groups

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Based on our results, statistically significant differences were found [Table 2] and [Figure 3] in the pain among the three groups at all times (P < 0.05). The pain score was lower in the MAR-DEX group, while higher in the PBO group (P < 0.001). Moreover, as depicted in [Table 3] the lowest opioid use (Meperidine) among was seen in the MAR-DEX group, next in the MAR group, but the PBO group showed the highest for 24 h (P < 0.001). Significant differences were observed in opioid use (Meperidine) among the groups (P < 0.001). The lowest opioid use was in the MAR-DEX group, and next in the MAR group, while the highest in the PBO group for 24 h.
Table 2: Comparison of mean and standard deviation of pain score in the three studied groups

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Table 3: Comparison of mean and standard deviation of opioid use in the three groups

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Figure 3: Comparison of pain score in the three groups

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  Discussion Top


The study addressed the hemodynamic and analgesic effects of SC dexmedetomidine versus Marcaine 5.0% on hernia surgery patients. The BMI, age, and gender were statistically the same among the three groups. In addition, our groups were not different regarding duration of surgery and MAP. Our main results showed that adding dexmedetomidine to bupivacaine during SC injection creates a preventive effect for pain and reduced opioid use for surgery without any side effect.

Dexmedetomidine is a highly selective alpha-2 adrenergic agonist and a compound derived from imidazole and exerts analgesic effects at the spinal cord level. The sedative effect of dexmedetomidine has a different quality than that of other IV anesthetics since it has analgesic effects without decreasing respiratory depression, reduces the intraoperative opioid use, and improves pain scores,[12] as well as maintains the local analgesia for a considerable period after the analgesic effect disappeared, reducing the need for analgesic agents.[15] Based on our results, SC injection of dexmedetomidine plus Marcaine relieved pain in patients and besides reduced opioid use during 24 h postoperatively. Due to the slow drug absorption, especially by injection at the incision site, the effects of analgesia are better and longer and no systemic complication occurs, while this injection technique is associated with fewer complications such as coughing and movement which exacerbate the patient's pain and immobility, as well as allowing faster mobility and reducing postoperative complications. On the other hand, systemic effects of high-dose IV dexmedetomidine can result in a decreased HR/BP which is highly dangerous for people with heart disease,[19] while this will not occur with SC administration.

Tobias study assessed the effects of SC dexmedetomidine on withdrawal symptoms and showed that it can be effective in these children.[18] Similarly, Hilliard et al. reported a case report regarding the efficacy of subcutaneously administered dexmedetomidine in treating pain and delirium, resulting in improved pain and delirium as well as successful patient treatment, and reported that the medication is a suitable therapeutic option for these patients.[20] Certainly, no result has been forthcoming since it was a case report for an end-stage cancer patient; hence, extensive interventional studies should be performed on the effect of SC injection of dexmedetomidine. Moreover, another study used SC dexmedetomidine to monitor changes in vital symptoms and states that dexmedetomidine is a good and suitable drug for sedation in SC injection, and sedation and cardiovascular system suppression are much lower than IV injection.[21]

Uusalo et al.'s study aimed at exploring subcutaneously administered dexmedetomidine, as well as its cardiovascular effects, and reflected that the medication can be a valuable alternative to pain relief and help attenuate cardiovascular effects compared with IV administration,[21] whose results were in line with ours. Similarly, the 2015 study by Ülgey et al. was conducted on 50 patients undergoing abdominal hysterectomy in Turkey, who were randomly split into two groups: the first and second received infiltration of the surgical area with levobupivacaine and levobupivacaine-dexmedetomidine, respectively, 5 min before skin incision. After induction of anesthesia, levobupivacaine or levobupivacaine mixed with dexmedetomidine was injected into the SC tissue along the marked line of skin incision 5 min before the surgical incision. Meperidine consumption was found to be significantly lower in the second group, while pain score was less at resting 0, 2, and 4 h postoperatively and also at coughing, and the need for analgesia was high in the first.[22] Their results were consistent with ours.

Further, Sun et al.'s study aimed to evaluate IT bupivacaine alone, bupivacaine plus fentanyl, and bupivacaine plus dexmedetomidine and included 90 patients undergoing cesarean section, assessing the duration of sensory and motor block and postoperative pain.[23] The combination of bupivacaine and dexmedetomidine prolonged the duration of block and increased postoperative analgesia in the participants, whereas no significant difference was observed in neonatal Apgar score among their groups. They concluded that the mixture can better manage pain and prolong the duration of sensory and motor block,[23] whose results on the duration of analgesia were consistent with ours.

Besides, a case study (Hilliard et al., 2014) reported a case of SC dexmedetomidine in the treatment of pain and delirium, in which the medication was used for an end-stage cancer patient with neuropathic pain and delirium. A 55-year-old female patient with cervical cancer and pelvic pain received dexmedetomidine subcutaneously for 3 weeks and, finally, whose pain and delirium improved and treatment was successful. They reported that the medication may hold valuable therapeutic potential for these patients and that more extensive future studies are required,[20] whose results were consistent with ours.

However, this study exposed to some limitations. First, pain is a subjective item and pain reporting in different individuals is related to different variables. Second, surgery type and gender effect were another limitation of this study. However, inguinal hernia occurs in men more often than women, but women commonly have increased pain sensitivity. Third, long-time complications of intervention did not measure in this study and it is suggested for future studies with larger sample size.


  Conclusion Top


Adding dexmedetomidine to bupivacaine during SC injection relieved pain and reduced opioid use in hernia surgery scheduled patients, without any adverse effects within 24 h postoperatively.

Acknowledgments

This study is the result of a dissertation on anesthesiology residency, with the code of ethics of IR.ARAKMU.REC.1397.131 and the Iranian Clinical Trial code IRCT20141209020258N99. Finally, we would like to thank the Clinical Research Council at Valiasr Hospital for their guidance and the research deputy of Arak University of Medical Sciences for his assistance and support.

Financial support and sponsorship

This study was financially supported by Arak University of Medical Sciences.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

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