|Year : 2020 | Volume
| Issue : 2 | Page : 172-178
Postoperative analgesic effect of intrathecal dexmedetomidine on bupivacaine subarachnoid block for open reduction and internal fixation of femoral fractures
C Nwachukwu1, HO Idehen2, NP Edomwonyi2, B Umeh1
1 Department of Anaesthesiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria
2 Department of Anaesthesiology, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria
|Date of Submission||12-Mar-2019|
|Date of Acceptance||08-Jun-2019|
|Date of Web Publication||7-Feb-2020|
Dr. H O Idehen
Department of Anaesthesiology, University of Benin Teaching Hospital, Benin City, Edo State
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: One of the drawbacks of subarachnoid block is the short duration of analgesia particularly when adjuvants are not added to local anesthetics agent used. However, dexmedetomidine an α2-adrenergic agent has been found to possess analgesic effect. Aims: This study seeks to determine the analgesic efficacy of intrathecal 7.5 μg of dexmedetomidine and its side effects when used for open reduction and internal fixation (ORIF) of femoral fractures. Methodology: It is a prospective randomized, double-blinded study that was carried out in a Nnamdi Azikiwe University Teaching Hospital, Nnewi in Nigeria. Seventy American Society of Anesthesiologists I or II patients were randomized into two groups of 35 each to receive 3 ml of 0.5% hyperbaric bupivacaine combined with either 7.5 μg of dexmedetomidine in 0.3 ml of normal saline (Group D) or 0.3 ml of normal saline alone (Group S). Patient's outcome measures noted (time to first request of analgesia, proportion of patients with pain score <4 postoperatively using numerical rating scale [NRS], and total analgesic consumed in 24 h.). Results: The patients in Group D had a longer time to first request of analgesia, larger proportion of patients with pain score <4 using NRS in the 2nd h postoperatively and lower amount of total analgesic consumed compared to those in Group S. These differences between the two groups were all statistically significant. Furthermore, there was no difference in the incidences of side effects between the two groups (P > 0.05). However, the patient satisfaction was better in Group D. Conclusion: The addition of 7.5 μg of dexmedetomidine to bupivacaine for subarachnoid block in the management of femoral fractures using ORIF provided better anesthetic profile, particularly prolonged duration of postoperative analgesia without significant side effects.
Keywords: Intrathecal dexmedetomidine, open reduction and internal fixation, postoperative pain, subarachnoid block
|How to cite this article:|
Nwachukwu C, Idehen H O, Edomwonyi N P, Umeh B. Postoperative analgesic effect of intrathecal dexmedetomidine on bupivacaine subarachnoid block for open reduction and internal fixation of femoral fractures. Niger J Clin Pract 2020;23:172-8
|How to cite this URL:|
Nwachukwu C, Idehen H O, Edomwonyi N P, Umeh B. Postoperative analgesic effect of intrathecal dexmedetomidine on bupivacaine subarachnoid block for open reduction and internal fixation of femoral fractures. Niger J Clin Pract [serial online] 2020 [cited 2020 Oct 1];23:172-8. Available from: http://www.njcponline.com/text.asp?2020/23/2/172/277853
| Introduction|| |
A number of adjuvants have been added to local anesthetic agents for subarachnoid block to prolong the intra- and post-operative analgesia. Nonetheless, agents such as clonidine, midazolam, opioids, and neostigmine are associated with varying side effects profile. Opioids are commonly used adjuvant, they produce rapid onset and good quality of surgical block but with side effects such as pruritus, nausea, and vomiting. These prompted further search toward nonopioid analgesic.
Dexmedetomidine an α2–adrenergic receptor agonist which causes anxiolysis, sedation, analgesia and is sympatholytic with minimal respiratory depression but prolongs the postoperative analgesic effect with minimal side effects., However, there is a paucity of reports in our environment. This study seeks to validate the postoperative analgesic effect produced by intrathecal administration of 7.5 μg of dexmedetomidine with bupivacaine for open reduction and internal fixation (ORIF) of femoral fractures.
| Methodology|| |
This is a prospective randomized double-blinded placebo controlled study that was conducted in a Nnamdi Azikiwe University Teaching Hospital, Nnewi in Nigeria. Approval from the Institutional Ethics Committee, Nnamdi Azikiwe University teaching Hospital (NAUTH) Ethical Approval number NAUTH/CS/66/VOL 5 written informed consent from the patients was obtained. The patients scheduled for elective ORIF of femoral fractures were recruited for the study if they met the inclusion criteria From May 2015 to July 2016.
These include patients willing to give consent, the American Society of Anesthesiologists (ASA) Physical status Class I or II patients, age 18–50 years and height 155 to 175 cm which was determined using alternative measurement.
This is a means of estimating height from other measurable parts of the body, such as length of forearm (ulna), knee height, and demi-span. It can also be used to estimate body mass index (BMI) using mid-upper arm circumference. Height is estimated by measuring the point of the elbow (olecranon process) and the midpoint of the prominent bone of the wrist (styloid process).
The exclusion criteria include patients' refusal, known allergy to the study medication, BMI >30 kg/m2 determined using alternative measurement and patient with contraindication to spinal anesthesia.
A detailed preoperative evaluation was done with no sedative premedication administered. Seventy patients were randomized into two groups – Group D (received 3 ml of 0.5% hyperbaric bupivacaine plus 7.5 μg dexmedetomidine) and Group S (received 3 ml of 0.5% hyperbaric bupivacaine plus 0.3 ml of normal saline). The syringe and the containing drug were prepared by a junior resident anesthetist while the researcher who was blinded to the contents of the syringes performed the spinal anesthesia, assessed, cared for the patients, and recorded the study data. In other words, the patients and the researcher were both blinded to the study medication administered because they did not know the composition of drug given.
Baseline blood pressure, heart rate, ECG, and peripheral oxygen saturation were obtained and recorded. Patient's circulation was preloaded with 10–15 ml/kg of normal saline over 15 min prior to the establishment of subarachnoid block.
In the sitting position, anesthesia was achieved with the injection of 3 ml of 0.5% hyperbaric bupivacaine and 7.5 μg of dexmedetomidine in 0.3 ml normal saline or 3 ml of 0.5% hyperbaric bupivacaine plus 0.3 ml of normal saline based on the group randomization over 10–15 s into the subarachnoid space.
Blood pressure was monitored every 2 min for the first 10 min then, 5 min interval till the end of the surgery. Intraoperative side effects such as hypotension, bradycardia, respiratory depression, pruritus, sedation, shivering, nausea, and vomiting were managed and recorded appropriately.
Hypotension for this study was defined as a systolic blood pressure of <90 mmHg or 30% drop from the baseline mean arterial pressure value and treated with a bolus of intravenous fluid bolus and 5 mg aliquots of intravenous ephedrine if the hypotension persists. Bradycardia (heart rate <60 bpm) was treated with intravenous atropine 0.6 mg. Shivering was treated using warmed intravenous fluid, warm blanket, and adequate covering of patients. The proportion with a complaint of nausea, vomiting, or retching was determined and documented. Nausea and vomiting were treated with intravenous metoclopramide 10 mg. Oxygen was administered through a face mask whenever the oxygen saturation dropped to ≤93%. Normal saline was used for fluid maintenance at 10 ml/kg for the 1st h and 5 ml/kg subsequently while blood loss was replaced with blood transfusion when the calculated maximum allowable blood loss was exceeded. The patients' sensory and motor block characteristics such as onset and duration of blocks and intraoperative events were documented.
After the establishment of the subarachnoid block, the block height was assessed every 2 min until the maximum block height reached for two consecutive tests. The desired sensory block height of T10 was achieved before the commencement of surgery, the time noted while the time to reach the maximum sensory block height was also noted.
The motor block was assessed using the modified Bromage score (Bromage 0 - free movement of legs and feet with ability to raise extended leg, Bromage 1 - inability to raise extended leg and knee flexion is decreased, but full flexion of feet and ankle is present, Bromage 2 - inability to raise leg or flex knees but flexion of ankle and feet is present, and Bromage 3 - inability to raise leg, flex knee or ankle or move toes). This was assessed every 2 min after intrathecal injection of the drugs and time taken to reach modified Bromage score 3 noted. Patients level of sedation was monitored every 15minutes using the modified Ramsay Sedation scale. In this scale, sedation was assessed with a four-point verbal rating scale (1 = no sedation, 2 = light sedation, 3 = somnolence, 4 = deep sedation). The pain was assessed using numeric rating scale (NRS) between 0 and 10 (0 - No pain and 10 - worst pain imaginable). This was assessed postoperatively every hour till the 4th h, then at 8 h, 12 h, 18 h, and 24 h. The sensory and motor block level was determined at the end of the surgery and monitored every 20 min to detect the time for block regression to S1 and modified Bromage 0, respectively (calculated from the time of subarachnoid drug administration). The patient was transferred to the ward for continued care when stable.
Time to first analgesic request which was the time from intrathecal administration of the study drugs to the time for the first request of analgesics when NRS ≥4 was documented, and 30 mg of pentazocine was administered intravenously. After this, the postoperative pain management continued with intravenous administration of 30 mg pentazocine on demand and not <4 hourly when NRS is ≥4.
Measurement of outcomes
- Primary Outcomes:- Duration of analgesia, the proportion of patients scoring <4 points at various time intervals using NRS
- Secondary Outcomes: Hemodynamic profile and sedative profile of study medication. Total analgesic requirement within 24 h postoperatively. Patient satisfaction using 5 points Likert scale which was assessed as excellent, very good, good, poor, and very poor.
Sample size estimation
Sample size, 35 patients in each group, was determined prospectively using data from a previous study by Tan et al. where it was found that the mean time to first request of rescue analgesia was 366 min (standard deviation [SD] 72) in the placebo group.
This study sought to extend the mean time to first request for analgesia by 60 min with the addition of 7.5 μg of dexmedetomidine to 15 mg of 0.5% hyperbaric bupivacaine. The sample size was determined by the formula.
The data collected were analyzed using Statistical Package for the Social Sciences version 20 developed by International Business Machines (IBM) Corporation of the United States of America. The parametric data were summarized as means and SD and dichotomous data presented as counts and frequencies. The comparison of time to the request of first analgesia was done using the unpaired t-test. Categorical data were analyzed using the Chi-square test. The level of statistical significance was set at P ≤ 0.05.
| Results|| |
A total of 70 adults aged 18–50 years in ASA class I and II were enrolled in this study, with 35 patients in each group. No patient was lost to protocol violation. The demographic characteristics and mean duration of surgery between the study groups, as shown in [Table 1].
The sensory and motor block characteristics are shown in [Table 2].
|Table 2: Sensory and motor block characteristics of the study groups (mean±standard deviation)|
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The time to first analgesic request and mean total analgesic consumption in the first 24 h are shown in [Table 3].
|Table 3: Time to first analgesic request and total analgesic consumed (mean±standard deviation) n=35|
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The proportion of patients with NRS for pain <4 at various intervals is shown in [Table 4].
|Table 4: Proportion of patients with numerical rating scale <4 and corresponding mean pain scores at various time intervals in both groups (n=35)|
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The hemodynamic variables between the two groups showed no significant difference with time (P > 0.05).
The sedation scores of the patients in both groups were comparable, as shown in [Table 5], with no level of significance in their mean scores at various time intervals (P > 0.05). The median sedation scores of the patients in both groups were comparable and found to be 2.
|Table 5: Sedation scores of the study groups (mean±standard deviation) n=35|
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There was no statistical difference in the incidence of side effects between the two groups, as shown in [Table 6].
The level of satisfaction of patient pain management using Likert scale is shown in [Table 7].
| Discussion|| |
This study showed that the addition of intrathecal dexmedetomidine to bupivacaine for subarachnoid block resulted in prolonged postoperative analgesic period without significant side effects. This assertion was made because at least 3 extra hours postoperatively was added before patients requested for their first analgesic, lower pain scores in the postoperative period and reduced total analgesic consumed in the first 24 h in the dexmedetomidine compared to the control group.
The first analgesic request time is not only affected by the dose of dexmedetomidine administered but the amount of LA that is added to it. Ramila et al. reported that the time to first analgesic request was significantly longer in the group that had dexmedetomidine with a duration of 274 min compared to the placebo group with 216 min (P < 0.05). The time extension reported by Ramila was shorter than the time found in this study. This may be due to a lower dose of dexmedetomidine (5 μg) that was used in their study. This prolongation of time to first analgesic request was also observed by Rakesh. It was noticed that the time extension in the dexmedetomidine group was shorter than the time noted in this index study despite using a larger dose of dexmedetomidine (10 μg). This could be as a result of lower dose of hyperbaric bupivacaine (2.5 ml) used in their study compared to 3 ml used in this study.
The proportion of patients with an NRS score of <4 was observed to be more among Group D patients compared to Group S in this study. This outcome shows that the addition of dexmedetomidine resulted in superior analgesic profile compared to placebo. The use of adjuvant dexmedetomidine extended the duration of pain relief in the postoperative period by at least 3 h in all the patients in the group. This outcome is in contrasts to the result obtained when no adjuvant was used because some of the patients in the Group S (without dexmedetomidine) experienced pains from the 1st h postoperatively [Table 4]. It is clear from the foregoing that the use of dexmedetomidine in this study extended the duration of postoperative analgesia by at least 3 h.
In Ramila et al. study, they observed that intrathecal addition of dexmedetomidine to bupivacaine spinal anesthesia resulted in an increase in the proportion of patients that were pain free in the postoperative period. They found that the patients that received placebo were pain-free postoperatively up to the 3rd h contrary to the finding in our study in which no patient was pain free among the placebo group at the 3rd h postoperatively. This difference in results may be due to the type of procedures they carried out; surgeries carried out included those of the foot, ankle, and tibia fibula which were of lower dermatomes compared to ours. Ankle surgeries (L5S1) with lower dermatomes take a longer time to experience postoperative pain compared to femoral surgeries (L2/L3) with higher dermatomal level.
It was observed from our study that prolonged duration of analgesia due to the longer time to the first request for analgesia reduced the analgesic requirement in the dexmedetomidine group. This reduction in analgesic requirement was similar to that reported by Mahendru et al. and Gupta et al. Hala Eid et al., Aditi et al., and Chaudhry et al. observed that the total analgesic consumption in the first 24 h has been found to decrease with increased dose of dexmedetomidine.
The addition of dexmedetomidine did not have any profound hemodynamic changes as observed in this study. This is as a result of the negligible effect low-dose intrathecal dexmedetomidine has on sympathectomy. Sympathectomy is almost maximal with the use of local anesthetic agents alone. The addition of low dose dexmedetomidine to the local anesthetic does not significantly affect the near maximal sympathectomy. This can explain the negligible effect of the drug on blood pressure and pulse rate.
Our findings that dexmedetomidine when added to bupivacaine for spinal anesthesia did not significantly decrease the blood pressure and pulse rate were in keeping with the result of Ramila et al. The hemodynamic changes were not significantly different between the two groups (P > 0.05). Gupta et al. also noted that there was no statistically significant difference in the hemodynamic changes observed in their study (P > 0.05). The findings by these studies suggest that intrathecal dexmedetomidine does not cause significant hemodynamic effect when used as an adjuvant in spinal anesthesia.
Spinal anesthesia has been found to decrease the shivering threshold. Shivering following spinal anesthesia is due to a fall in core body temperature. This occurs in response to the core to peripheral redistribution of body heat due to peripheral vasodilatation that occurs in regional anesthesia which leads to heat loss. Dexmedetomidine reduces vasoconstriction and increasing shivering thresholds mediated by its central α2 activity. The incidence of shivering in the dexmedetomidine group in our study was clinically lower with 3% compared to 11% in the placebo group but no statistically significant different (P = 0.477). This could have resulted because of the low dose used. Sarma et al., and Gupta et al., both reported a nonstatistically significant difference in the incidence of shivering in their studies. However, Bajwa et al. in their study observed 5% incidence of shivering in the dexmedetomidine group compared to 42.5% in saline group (P = 0.014). The high dose of intravenous dexmedetomidine 1 μg/kg could be responsible for their outcome. Observation from Fahmy et al. was surprising as the addition of 10 μg dexmedetomidine to bupivacaine subarachnoid block resulted in 23.3% incidence of shivering in dexmedetomidine group compared to 56.7% in the saline group, these high incidences of shivering were of significant statistical difference (P < 0.05). The reason for the high incidence observed in their study compared to this index study cannot be explained although the author claimed they did not focus on postoperative side effects but only observed intraoperative side effect and this may have underestimated the role of adjuvant in preventing postoperative complications.
There was no statistical difference in the incidence of nausea between the two groups (3% each). This is because there was no significant difference in the incidence of hypotension between saline and dexmedetomidine group with 17% and 20%, respectively (P > 0.05). Hypotension causes cerebral hypoperfusion which results in nausea and vomiting. Our outcome was also corroborated by the studies conducted by Gupta et al. Rakesh et al. and Sarma et al. who reported a nonstatistically significant difference in the incidence of nausea.
Dexmedetomidine has sedative properties which is beneficial to patients who are cooperative, oriented, and tranquil. However, the sedation score observed in this study had no statistical significance difference at different time intervals between the two groups. This may be due to the low dose used in this study. The median sedation score observed in this study was 2 in both groups. Ramila et al. observed a mean sedation score of 1 in the saline group and 1.73 in dexmedetomidine group at the 60th min (P < 0.05). The lower sedation score in their study may be due to the lower dose of dexmedetomidine (5 μg) used. Nevertheless, increasing dose of dexmedetomidine also increases the level or proportion of patient sedated as reported by Aditi et al. and Hala Eid et al. It is believed that dexmedetomidine produces sedation centrally by activating the α2 adrenoceptors in the locus coeruleus.
The quality of the block associated with the intrathecal administration of dexmedetomidine was demonstrated in our study. The motor block characteristics showed that the time for motor regression to Bromage 0 was longer in the dexmedetomidine group compared to the saline group. This was also observed by Ramila et al. who reported a longer time in the dexmedetomidine group compared in saline group (P < 0.05). The shorter time observed in their study compared to the index study may be due to the lower dose of dexmedetomidine (5 μg) they used. This was also observed by other researchers. This motor block prolongation was also found to significantly increase with increased dose of dexmedetomidine as documented by Baghel et al. The prolongation of motor block following spinal anesthetic with the addition of dexmedetomidine may result from binding of the α2 adrenergic agonist to motor neurons in the dorsal horn. This prolongation of the duration of motor block is not beneficial, especially in the ambulatory surgeries or short and intermediate duration orthopedic surgical procedures where early ambulation is desirable. It is accepted that early mobilization is vital to avoiding postoperative medical condition such as deep venous thrombosis, urinary tract infection, pressure ulcer, and early hospital discharge. However, there is hesitancy among some surgeons to allow early ambulation after femoral and hip fracture surgeries using sliding screw plate fixation because of concern of mechanical failure thus, favoring prolonged motor block. Wolfgang et al. in their study on the treatment of intertrochanteric fracture of the femur found 9% mechanical fracture complication due to early ambulation.
Patients' level of satisfaction using the five levels Likert scale revealed that 5% of the patients rated the quality of analgesia as excellent, 90% as very good and the remaining 5% as good in Group D while 66% of patients in Group S rated as good while 34% rated it as poor. Thus, the level of satisfaction of the patients that received dexmedetomidine showed that there was a better quality of analgesia associated with the intrathecal administration of dexmedetomidine as an adjuvant in bupivacaine subarachnoid block. There is no information on the level of satisfaction from the available literatures. It is assumed that the studies that reported the same quality of analgesia as in this index study may probably report the same level of satisfaction because it is a measure adequacy of postoperative pain management.
| Conclusion|| |
This study has demonstrated that intrathecal administration of 7.5 μg of dexmedetomidine combined with 3 ml of 0.5% hyperbaric bupivacaine improved the quality of postoperative analgesia; reduced the requirement of postoperative rescue analgesia, stable hemodynamic condition, and minimal side effects.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]