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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 16  |  Issue : 3  |  Page : 314-318

Postoperative analgesia of ultra-low-dose naloxone versus dexmedetomidine with local anesthetic in peribulbar block in cataract surgery


1 Department of Anesthesia, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
2 Department of Ophthalmology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Date of Submission11-Dec-2018
Date of Acceptance27-Jan-2019
Date of Web Publication15-Apr-2019

Correspondence Address:
Ahmed M.M El-Garhy
Lecture of Anaesthesia and ICU faculty of Medicine Al Azhar University Cairo, 14 Aboelfda Street, From Elharam, Giza 12512
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AZMJ.AZMJ_135_18

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  Abstract 


Background and aim Regional anesthesia in eye surgery is a preferred technique and widely used in all eye surgery centers. It is safe, inexpensive, simple, and reliable and provides efficient ocular anesthesia. It is associated with less complications than general anesthesia. Among regional blocks, peribulbar block is safer in comparison with retrobulbar block owing to lesser incidence of complications such as retrobulbar hemorrhage, globe perforation, and brain stem anesthesia, but it has some disadvantages such as incomplete orbital and eyelid akinesia and decrease time of analgesia in which the patient need pain relief postoperatively, so many adjuvant drugs have been added to local anesthetic to overcome these disadvantages. Dexmedetomidine is a central-acting drug, a highly selective α2-agonist, that has been used as an additive to local anesthetic, whereas the mechanism of action of ultra-low-dose naloxone includes inhibition of impulses of the excitatory opioid receptors and release of encephalin. The goal of this study was to assess the effect of ultra-low-dose naloxone and dexmedetomidine as adjuvants for local anesthetic on duration of analgesia as primary outcome and akinesia of the globe and eyelid and occurrence of complications as a secondary outcome.
Patients and methods A total of 60 patients were included in this prospective randomized double-blind clinical study scheduled for elective cataract surgery, who were randomly divided into two groups: N group (n=30) received 3.5 ml of lidocaine 2%, 3.5 ml of bupivacaine 0.5% with 15 IU/ml hyaluronidase for both lidocaine and bupivacaine, and 100 ng naloxone in 1 ml normal saline. D group (n=30) received 3.5 ml of lidocaine 2%, 3.5 ml of bupivacaine 0.5% with 15 IU/ml hyaluronidase for both lidocaine and bupivacaine and 25 μg of dexmedetomidine in one-ml normal saline. The assessment includes duration of analgesia (h), which is the time from injection till visual analog scale of more than 4 or request of analgesia by the patient, akinesia of the globe and eyelid assessed every 2 min using a three-point scale, and occurrence of complications (pain during injection, chemosis, diplopia, bradycardia, and hypotension).
Results A total of 60 cataract surgery patients were included in the study. Regarding primary outcome (duration of analgesia), we found a highly statistically significant difference in duration of analgesia, with longer duration of analgesia in N group of patients compared with D group (P<0.01). Regarding secondary outcomes, we found a highly statistically significant difference in onset of globe akinesia, with a rapid onset of globe akinesia in D group compared with N group (P<0.01), and a highly statistically significant difference in bradycardia, with increased incidence of bradycardia in D group (P=0.0004).
Conclusion The addition of ultra-low-dose naloxone to local anesthetic in cataract surgery shows longer duration of analgesia.

Keywords: dexmedetomidine, local anesthetic, peribulbar block, ultra-low-dose naloxone


How to cite this article:
El-Garhy AM, Halim NE. Postoperative analgesia of ultra-low-dose naloxone versus dexmedetomidine with local anesthetic in peribulbar block in cataract surgery. Al-Azhar Assiut Med J 2018;16:314-8

How to cite this URL:
El-Garhy AM, Halim NE. Postoperative analgesia of ultra-low-dose naloxone versus dexmedetomidine with local anesthetic in peribulbar block in cataract surgery. Al-Azhar Assiut Med J [serial online] 2018 [cited 2020 Jul 14];16:314-8. Available from: http://www.azmj.eg.net/text.asp?2018/16/3/314/255853




  Introduction Top


Patient comfort, safety, and low complications rates are the essentials of local anesthesia in ophthalmic surgery. Different adjuvants are used before to improve the block potency, the duration of analgesia postoperatively, and akinesia intraoperatively [1],[2]. Peribulbar block is easily performed, is safe, has less painful but higher failure of rate, has shorter duration of analgesia, and has longer onset time compared with retrobulbar block, unless the use of adjuvants [2]. Different adjuvants such as adrenaline, sodium bicarbonate, magnesium sulfate, and fentanyl have been added to a mixture of local anesthetic used in peribulbar block to increase its efficacy, duration of analgesia, and speed of onset. Their effects were variable [3]. These agents are also not devoid of adverse effects like allergic reaction. Until date, no one adjuvant is ideal for peribulbar block [4]. Dexmedetomidine is a central-acting drug. It is a highly selective α2-agonist that has been used as an additive to local anesthetic in peripheral nerve block and subarachnoid block to shorten the onset and prolong the duration of analgesia [5]. Naloxone has proved to have paradoxical effects, as it antagonizes the opioid analgesia if given in high doses (μg) and produces antinociceptive effect if given in ultra-low dose (ng) [6]. Different mechanisms explained the effect of ultra-low-dose naloxone, and one of them includes inhibition of the impulses of the excitatory opioid receptors and encephalin release [7],[8]. It is used safely in the epidural and intrathecal routes to reducing the adverse effects of opioid or enhancing analgesia [9]. Moreover, it has been added to the mixture of fentanyl and lidocaine in peribulbar block and increases the duration of postoperative analgesia with no adverse effects [10].

Aim

The primary outcome of the study is to assess duration of analgesia, whereas the secondary outcome of the study is to assess akinesia of the globe and eyelid and occurrence of complications such as pain during injection, chemosis, diplopia, bradycardia, and hypotension.


  Patients and methods Top


Patients

This prospective randomized comparative double-blind clinical study was done in Al-Azhar University Hospital (Al-Hussein) from March 2018 to September 2018 following the local ethics committee approval, and informed written consent was taken.

A total of 60 patients between 55 and 70 years of age, with American Society of Anesthesiologists status I, II, and III, scheduled for elective cataract surgery were included in this study.

Exclusion criteria were as follows:
  1. Clotting abnormality.
  2. Patient taking anticoagulant.
  3. Mentally retarded patient or with difficulties in communication.
  4. Tremors or difficulties in controlling movement.
  5. High myopia with axial length more than 26 mm detected by ultrasonography.
  6. Allergy to any of the drugs used in the study.


The patients were randomized using a computer-generated random numbers and closed envelope into two groups:
  1. Group 1 (N group) ‘n=30’:
    1. This group received 100 ng naloxone in 1 ml normal saline and mixture of 3.5 ml lidocaine 2%, 3.5 ml bupivacaine 0.5% with 15 IU/ml hyaluronidase for both lidocaine and bupivacaine mixed in 10 ml syringe with 25 G short bevel needle.
  2. Group 2 (D group) ‘n=30’:
    1. Received 25 μg of dexmedetomidine in 1 ml normal saline and mixture of 3.5 lidocaine 2%, 3.5 ml bupivacaine 0.5% with 15 IU/ml hyaluronidase for both lidocaine and bupivacaine mixed in 10 ml syringe with 25 G short bevel needle.


Drugs used

Study medication such as benoxinate HCL drops 4% (Bronx; Epico Pharma, Dokki, Giza Governorate, Egypt), lidocaine HCL 2%. (debocain, Al Debeiky Pharmaceuticals, New Cairo, Egypt), bupivacaine HCL 0.5% (bucain; Delta Select, Dreieich, Germany), hyaluronidase (Hynidas Ovin India, shreya life sciences PVT LTD, Aurangbad, india), dexmedetomidine HCL (precedex; Hospital, Pfizer, New York, USA), Naloxone HCL anhydrous (naloxone; Mylan, Morgantown, West Virginia, USA) were prepared by a pharmacist who was not involved in the study. According to the randomization table, the anesthesiologist administered identical syringe with a code number by the pharmacist. All the team members in the work and the patients were blinded to the study medication.

Methods

All patients were requested to fast for 6–8 h before operation. Preoperatively a primary intravenous line was inserted and secured, and no preoperative medication was given. All patients were monitored for heart rate (beats/min), pulse oximetry, noninvasive mean arterial blood pressure (mmHg) every 5 min using (GE Datex-Ohmeda, GE healthcare, New York, USA) and oxygen supply 3 l/min via nasal cannula.

Topical local anesthetic (benox) was applied to the eye with the eye in the primary gaze position and the patient lying supine. A 10-ml plastic syringe with 25 G needle was used for local anesthetic injection. A volume of 4 ml of local anesthetic mixture was injected after aspiration test at the junction between the lateral one-third and medial two-thirds of the inferior orbital rim in posterior direction with needle depth insertion limited to 25 mm. Intermittent digital compression was applied to lower the intraocular pressure. The other 4 ml of local anesthetic was given between the caruncle and the medial canthus, and intermittent gentle compression was applied to lower the intraocular pressure.

After administration of the local anesthetic in both groups, each patient was evaluated for the following:
  1. Akinesia of the globe and eyelid (time of onset/min) assessed every 2 min. It is the time from injection till globe akinesia score 1 and eyelid akinesia score 0. Akinesia (globe and eyelid) was assessed using scale of 0, 1, and 2 (0=no movement, 1=limited movement, and 2=normal movement).
  2. Duration of analgesia (time/h). It is measured from time of local anesthetic injection till visual analog scale (VAS) more than 4 or request of analgesia by the patient. It is measured every 1 h for 6 h and then every 3 h for 6 h. If a patient requests analgesia or VAS was more than 4, ketorolac 30 mg intramuscularly is given.
  3. Occurrence of any complications such as pain during injection, chemosis, diplopia, bradycardia, and hypotension. If bradycardia occurs, 6 mg atropine is given.


Statistical analysis

Data entry, processing, and statistical analysis were carried out using MedCalc, ver. 15.8. (MedCalc, Ostend, Belgium). Tests of significance (Mann–Whitney’s U-test, χ2, factorial analysis of variance tests, Spearman’s correlation coefficient, and multiple regression analysis) were used. Data were presented, and suitable analysis was done according to the type of data (parametric and nonparametric) obtained for each variable. P values less than 0.05 (5%) was considered to be statistically significant.


  Results Top


In this study, 60 cataract surgery patients between 55 and 70 years were included in the study. Regarding demographics, American Society of Anesthesiologists, and duration of operation, there was no statistically significant difference, as shown in [Table 1].
Table 1 Basic demographic and clinical data

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Regarding the duration of analgesia, follow-up period (12 h) revealed the following:
  1. A highly statistically significant difference in the duration of analgesia, with a longer duration of analgesia in N group compared with D group patients. The median value of duration of analgesia in D group was 4.5 h, whereas in N group was 7.4 h, with a highly significant statistical difference (P<0.001), as shown in [Table 2].
    Table 2 Comparison between D and N groups regarding duration of analgesia and visual analog scale score

    Click here to view
  2. A statistically nonsignificant difference in VAS scores at 1 to 6 h in N group compared with D group (P>0.05), as shown in [Table 2].
  3. A highly statistically significant difference in VAS scores at 9–12 h in N group compared with D group. The median value of VAS score was 5, 5, 5 in D group and 3, 2, 5 in N group at 6, 9, 12 h, respectively, with highly significant statistical difference (P=0.0001), as shown in [Table 2].


Regarding the onset of akinesia, follow-up period revealed the following:
  1. Onset of globe akinesia is rapid in D group compared with N group . The median value of onset of globe akinesia in D group was 6 min, whereas in N group was 8 min, with a highly significant statistical difference (P<0.001), as shown in [Table 3].
    Table 3 Comparison between D and N groups regarding onset of akinesia

    Click here to view
  2. There was a nonsignificant difference in onset of eyelid akinesia between the two groups (P>0.05). The median value of onset of eyelid akinesia in D and N groups was 8 min, as shown in [Table 3].


Regarding the occurrence of complications in the follow-up period, it revealed the following:
  1. A highly statistically significant difference in the incidence of bradycardia in D group compared with N group, with a highly significant statistical difference (P=0.0004), as shown in [Table 4].
    Table 4 Comparison between D and N groups regarding complications

    Click here to view


Regarding correlation studies regarding the onset of akinesia, it revealed the following:
  1. Multiple regression analysis shows that after applying (forward method) and entering some predictor variables, the decrease in age, and the increase in naloxone usage, had an independent effect on increasing onset of akinesia (eyelid); with significant statistical difference (P<0.01), as shown in [Table 5].
    Table 5 Multiple regression model for the factors affecting onset of akinesia (eyelid) using forward method

    Click here to view
  2. Multiple regression analysis shows that after applying (forward method) and entering some predictor variables, the decrease in operative duration, and the increase in age and duration of analgesia, had an independent effect on increasing onset of akinesia (globe), with significant statistical difference (P<0.01), as shown in [Table 6].
    Table 6 Multiple regression model for the factors affecting onset of akinesia (globe) using forward method

    Click here to view



  Discussion Top


Patient comfort, safety, and low complications rates are the essentials of local anesthesia in ophthalmic surgery. Many adjuvants were tried before to help to improve the potency of the block and increase the duration of analgesia and akinesia intraoperatively.

Regarding primary outcome (duration of analgesia), a comparative study between the two groups revealed a highly statistically significant difference in the duration of analgesia, with longer duration in N group compared with D group patients (P<0.01). The median value of duration of analgesia in D group was 4.5 h, whereas in N group was 7.4 h, with a highly significant statistical difference (P<0.001). These results are in agreement with Ezz and Elkala [10], who reported that the time to first rescue analgesic (h) was significantly longer in group N (7.73±0.98) than group D (4.30±0.47) (P<0.001).

Moreover, Elsayed and Hasanein [11] reported greater reduction in intraoperative and postoperative VAS among patients who received low dose of naloxone compared with control group. Moreover, intraoperative fentanyl requirement was less in naloxone-treated patients, and fentanyl requirement for the first time was significantly longer in naloxone-received patients than the other group.

Regarding secondary outcome (onset of globe akinesia), a comparative study between the two groups revealed highly statistically significant difference in the onset of globe akinesia, with rapid onset in D group compared with N group of patients (P<0.01). The median value of onset of globe akinesia in D group was 6 min, whereas in N group was 8 min, with highly significant statistical difference (P<0.001). These results are in agreement with Channabasappa et al. [5] who evaluated the effect of adding different doses of dexmedetomidine to mixture of bupivacaine and lidocaine in peribulbar anesthesia, and they reported that the onset of globe akineasia and corneal anesthesia was significantly shorter in group D than in other group.

Comparative study between the two groups revealed a nonsignificant difference in the onset of eyelid akinesia between the two groups (P>0.05). The median value of onset of akinesia (eyelid) in D and N groups was 8 min. These results are in agreement with Mahmoud et al. [2], who reported that there was no statistically significant difference between the two groups regarding the onset of globe akinesia and eyelid akinesia (P>0.05).

Moreover, a comparative study between the two groups revealed a highly statistically significant difference in incidence of bradycardia in D group compared with N group patients. These results are in agreement with Ezz and Elkala [10], who reported that regarding complications, one (3.33%) patient in group I and two (6.67%) patients in group II had chemosis, whereas three (10%) patients in group I and two (6.67%) patients in group II had painful injection. No postoperative squint or diplopia, and perforation or penetration of the globe occurred in any patient.

Multiple regression analysis shows that after applying (forward method) and entering some predictor variables, the decrease in age and the increase in naloxone usage had an independent effect on increasing onset of akinesia (eyelid); with significant statistical difference (P<0.01). The previous results are in agreement with Mehta et al. [12].

Multiple regression analysis shows that after applying (forward method) and entering some predictor variables, the decrease in operative duration and the increase in age and duration of analgesia had an independent effect on increasing onset of akinesia (globe); with significant statistical difference (P<0.01). The previous results are in agreement with Mehta et al. [12].

Logistic regression analysis shows that after applying (forward method) and entering some predictor variables, the increase in age had an independent effect on increasing the probability of complications occurrence, with significant statistical difference (P=0.0001). These results are in agreement with Ezz and Elkala [10].


  Conclusion Top


The addition of ultra-low-dose naloxone to local anesthetic in cataract surgery showed longer duration of analgesia, with slow onset of globe akinesia.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Eghbal MH, Tabel H, Taregh SA, Razeghinejad MR. The effect of addition of low dose atracurium to local anesthetic in retrobulbar block for cataract surgery. Middle East J Anaesthesiol 2010; 20:535–538.  Back to cited text no. 1
    
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Mahmoud MS, Al Alim AAA, Hefni AF. Dexamethasone bupivacaine versus bupivacaine for peribulbar block in posterior segment eye surgery. Egypt J Anaesth 2013; 29:407–411.  Back to cited text no. 2
    
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Sinha R, Sharma A, Ray BR, Chandiran R, Chandralekha C, Sinha R. Effect of addition of magnesium to local anesthetics for peribulbar block: a prospective randomized double-blind study. Saudi J Anaesth 2016; 10:64.  Back to cited text no. 3
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Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol 2013; 65:4–8.  Back to cited text no. 4
    
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Channabasappa SM, Shetty VR, Dharmappa SK, Sarma J. Efficacy and safety of dexmedetomidine as an additive to local anesthetics in peribulbar block for cataract surgery. Anesth Essays Res 2013; 7:39.  Back to cited text no. 5
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Okutomi T, Saito M, Mochizuki J, Amano K. Prophylactic epidural naloxone reduces the incidence and severity of neuraxial fentanyl-induced pruritus during labour analgesia in primiparous parturients. Can J Anaesth 2003; 50:961–962.  Back to cited text no. 9
    
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Ezz HAA, Elkala RS. Ultra-low-dose naloxone added to fentanyl and lidocaine for peribulbar anesthesia: a randomized controlled trial. Egypt J Anaesth 2015; 31:161–165.  Back to cited text no. 10
    
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Elsayed W, Hasanein R. A randomized controlled study of the effects of adding ultra low dose naloxone to lidocaine for intravenous regional anesthesia. Egypt J Anaesth 2016; 32:213–217.  Back to cited text no. 11
    
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Mehta S, Laird P, Debiec M, El-sayed W, Hasanein R. Formulation of a peribulbar block for prolonged postoperative pain management in vitreoretinal surgery a randomized clinical trial. Ophthalmol Retina 2018; 2:268–275.  Back to cited text no. 12
    



 
 
    Tables

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



 

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