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Year : 2021  |  Volume : 5  |  Issue : 2  |  Page : 66-71

A randomized control trial on comparative effect of scalp nerve block using levobupivacaine versus fentanyl on the attenuation of pain and hemodynamic response to pin fixation

1 Department of Critical and Intensive Care, All India Institute of Medical Sciences, New Delhi, India
2 Department of Anesthesiology, Rama Medical College, Hapur, Uttar Pradesh, India
3 Department of Anesthesiology, All India Institute of Medical Sciences, Patna, Bihar, India
4 Department of Anesthesiology, SKMCH, Muzaffarpur, Bihar, India
5 Department of Anesthesiology and Intensive Care, SSSIHMS Whitefield, Bengaluru, Karnataka, India

Date of Submission21-Aug-2020
Date of Decision14-Nov-2020
Date of Acceptance22-Nov-2020
Date of Web Publication16-Apr-2021

Correspondence Address:
Dr. Shagufta Naaz
Department of Anaesthesiology, ll India Institute of Medical Sciences, Patna, Bihar
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/BJOA.BJOA_183_20

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Background: The application of head fixation device and tightening of the pins on the scalp acts as an intense noxious stimulus with an increased hemodynamic response. We aimed at comparing the efficacy of scalp nerve block (SNB) using levobupivacaine against intravenous fentanyl bolus dose followed by continuous intravenous infusion for attenuation of pain and hemodynamic response to pin fixation. Methods: One hundred and eight patients undergoing elective supratentorial craniotomy under general anesthesia were randomly allocated to two groups: Group F received a bolus of intravenous fentanyl (2 μg/kg) followed by continuous maintenance infusion and Group S, in which a bilateral SNB was performed with 20 ml of 0.5% levobupivacaine. Hemodynamic variables and pain scores were the primary outcomes noted. Intraoperative isoflurane and additional fentanyl requirements, emergence time and any side effects were also recorded. Results: The variation in hemodynamics in terms of heart rate (per minute) at pin fixation (Group F [95.88 ± 7.79] and Group S [89.02 ± 5.42]) was significant (P < 0.001). There was a significant change in mean arterial blood pressure (mm Hg) between the groups at pin fixation Group F (104.70 ± 9.18) and Group S (92.88 ± 6.92) (P < 0.001). A significant reduction in pain and intraoperative fentanyl requirements was also seen. Emergence from anesthesia was significantly longer in Group F as compared to Group S (P < 0.001). No group had any significant complication. Conclusion: SNB is a reasonably safe and effective means for smooth control over hemodynamics and lesser intraoperative analgesic requirements compared to the fentanyl infusion in adult patients undergoing supratentorial craniotomies.

Keywords: Analgesics, craniotomy, intravenous infusion, levobupivacaine, nerve block

How to cite this article:
Altaf I, Banday J, Naaz S, Ozair E, Punetha P, Challam KS. A randomized control trial on comparative effect of scalp nerve block using levobupivacaine versus fentanyl on the attenuation of pain and hemodynamic response to pin fixation. Bali J Anaesthesiol 2021;5:66-71

How to cite this URL:
Altaf I, Banday J, Naaz S, Ozair E, Punetha P, Challam KS. A randomized control trial on comparative effect of scalp nerve block using levobupivacaine versus fentanyl on the attenuation of pain and hemodynamic response to pin fixation. Bali J Anaesthesiol [serial online] 2021 [cited 2022 Aug 18];5:66-71. Available from: https://www.bjoaonline.com/text.asp?2021/5/2/66/313877

  Introduction Top

Anesthetic management of the patients undergoing craniotomy for various indications can often be challenging, given the nature of the surgery, underlying central nervous system pathology, and the need for immediate postoperative neurological assessment.[1] In order to maintain the desired position and immobilization of head during the neurosurgical procedures, the application of a fixation device and tightening of pins on the scalp acts as an intense noxious stimulus with a profound stimulating effect.[2] This leads to the acute sympathetic stimulation and increase in stress response, which can be detrimental, especially in patients with exhausted intracranial compensatory mechanisms.[3]

Several studies have been done to assess the efficacy of the analgesic drugs and various pharmacological techniques to blunt this deleterious effect, but with variable success. The idea of combining a regional with a general anesthetic as an adjuvant may offer advantages for most patients so as to reach a consensus on the best anesthetic technique for use in neurosurgery.[4] Blocking noxious input to the abundant sensory nerve supply of the scalp would prevent the hemodynamic response to pin fixation and the pain of incision with the potential for postoperative effect.[5]

Levobupivacaine has strongly emerged as a safer alternative for regional anesthesia than its racemic sibling, bupivacaine. An amino-amide local anesthetic drug belonging to the family of n-alkyl substitute pipecoloxylidide, levobupivacaine specifically binds with the intracellular portion of sodium channels and blocks the influx of sodium into nerve cells, which prevents depolarization.[6],[7] The aim of the study was to compare the efficacy of the two different techniques of attenuating the pain and hemodynamic response to pin fixation in patients undergoing supratentorial neurosurgical procedures.

  Methods Top

This randomized comparative, double-blind, parallel-arm, prospective study was done after obtaining Institutional Ethics and Scientific Committee approval (Registry number HR/20/1473 dated 13.06.2014) in a tertiary medical institute between June 2014 and December 2015. One hundred and eight adult patients of American Society of Anesthesiologists (ASA) physical status I and II, either sex, between 18 and 65 years of age undergoing elective craniotomy for newly diagnosed supratentorial brain lesions, were randomly allocated into two groups in the study, after obtaining verbal and written informed consent. The patients were explained about the nature of anesthesia and optional techniques to be utilized.

Out of 125 patients enrolled, 12 patients did not meet the inclusion criteria, and five declined to participate; 108 were randomly allocated into two groups of 54 patients each based on computer-generated numbers. Eight patients did not receive the intervention, and a hundred patients were analyzed, each group consisting of fifty patients [Figure 1].
Figure 1: Consort flow diagram

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Patients with ASA class III and above, preoperative GCS <15, those with midline shift of more than 5 mm on CT head scan, patients who had undergone previous brain surgery, patients with intracranial aneurysms, patients with cardiovascular diseases, those allergic to local anesthetics, who received any analgesic 24 h before surgery, incision extending beyond the areas covered with scalp-nerve block, coagulopathy or patients on medications affecting coagulation system, having hepatic, and renal failure were excluded from the study.

Before the induction of general anesthesia, patients were positioned supine on the OT table with all standard ASA monitors along with bispectral index (BIS) attached, and baseline vital parameters were noted. All patients were preoxygenated with 100% oxygen for 3 min and induced with intravenous injections of fentanyl (2 μg/kg), thiopentone sodium (5 mg/kg) followed by vecuronium (0.1 mg/kg).

Intravenous injection of preservative-free 2% lidocaine (1.5 mg/kg) was given 90 s before intubation. The induction was considered as adequate if the heart rate (HR) and mean arterial pressure (MAP) immediately following the intubation remained within 20% of the patient's baseline ward values, and BIS was between 40 and 60 to maintain adequate depth of anesthesia. Maintenance of anesthesia was carried out with minimum alveolar concentration isoflurane so as to maintain the BIS 40–60, in nitrous oxide and oxygen mixture (60:40), using Datex Ohmeda, Avance CS2 Anesthesia work station and top-up doses of vecuronium were given as and when required. Following induction, central venous and arterial cannulations were done, and central venous pressure and invasive blood pressure monitoring started.

Following general anesthesia, as mentioned above, each of the two groups received the intervention according to the randomly assigned group. Patients in Group F (Fentanyl) received a single intravenous bolus of injection fentanyl 2 μg/kg 10 min before pin insertion followed by continuous infusion of 1 μg/kg/hour till the end of surgery (dural closure). Group S (Scalp Nerve Block [SNB]) patients received a bilateral SNB with 20 ml of 0.5% levobupivacaine, 10 mL on each side 10 min before pin insertion under sterile precautions.[8] The dose of levobupivacaine was calculated not to exceed 3 mg/kg of the patient's body weight.[9]

Patients' pain intensities were measured preoperatively and postoperatively with a standard ten-point numerical pain rating scale (NRS) where 0 meant no pain and 10 meant the worst imaginable pain. Intraoperatively, we employed the Anaesthetised Patient Pain Scale (APPS)[10] to measure the pain scale. The pain was initially scored just before administering SNB or fentanyl, and subsequently, if there was ≥20% increase in two or more baseline vital signs or pain indicators, as observed on the patient's monitor and outlined in the APPS. If following pin insertion or in the latter part of the study, pain score was found to be more than 9 in either group, it was treated immediately in successive steps. The first step was to give a single bolus intravenous administration of fentanyl 1 μg/kg. The patient was reassessed after 5–15 min of treatment using the APPS. The second step was to administer a 0.5 mg/kg intravenous bolus injection of propofol. Sixty seconds' time was utilized as repeat, and large boluses were associated with significant hypotension. If the second step did not decrease the APPS score to ≤9, the third step was to give an increasing concentration of isoflurane up to 2 MAC. However, care was taken at all times to maintain BIS 40–60.

It was planned that the study would be abandoned if any untoward event, blood loss exceeding more than 20% of blood volume, persistent hypotension not responding to vasopressors, but requiring the ionotropic support, bradycardia, anaphylaxis or inadvertent intra-arterial injection of levobupivacaine was encountered.

Statistical software, namely SPSS (IBM Corp. Released 2010. IBM SPSS Statistics for Windows, Version 19.0. Armonk, NY, USA: IBM Corp.) was used for data analysis.Descriptive and inferential statistical analyses had been carried out. The outcome of continuous variables were depicted as mean ± SD and that of categorical measurements were presented in number or percentage. Significance level was measured at 5% (P < 0.05). Kolmogorov–Smirnov test was utilized to test normality of variables. If the data were normally distributed, an unpaired t-test was applied. Kruskal–Wallis H test was applied to the data not normally distributed. Chi-square or Fisher's exact test had been utilized to evaluate the data derived from numerical scale. P < 0.05 was considered significant.

  Results Top

This study was carried out on a total of 100 patients who underwent supratentorial craniotomies for various indications. Demographic data, intraoperative and postoperative hemodynamics, and perioperative analgesic requirements were compared between Group F (Fentanyl) and Group S (SNB). The demographic variables among the two groups [Table 1] showed no statistically significant difference among the groups. Repeated measures ANOVA had been performed to account for the repeated measures from the data [Table 2].
Table 1: Comparison of demographic variables of the study population

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Table 2: Comparison of mean arterial pressure and mean heart rates

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The use of the NRS score and pain management techniques in this study assessed a significant difference in pain intensity among the two groups at the immediate postoperative period which had a mean pain intensity score of 5.37 ± 1.73 for group S as against a pain intensity score of 6.57 ± 2.79 for group F which differed significantly (P = 0.01). The initial mean preoperative pain score of 4.47 ± 2.37 for Group S had no significant difference from 4.10 ± 3.28 for group F.

Patients in Group F required significantly more fentanyl supplementation, where 29 patients needed more than 50 μg in addition to maintenance infusion than Group S, in which only six patients required 50 μg. There was highly significant difference between total mean rescue analgesia of Group F and Group S (55.17 ± 15.49 vs. 50.00 ± 0.00, P < 0.001). Intraoperatively, there were highly significant differences in the APPS pain scores of the two groups (P < 0.001).There was also reduced time to awakening after pin release (8.50 ± 2.72 min) in the SNB group as compared to the fentanyl group (17.40 ± 4.65 min). No significant adverse event such as bleeding, hypotension, delayed emergence, nausea, vomiting, and allergic reactions was noted between the two groups.

  Discussion Top

Though there is an accepted practice by many neurosurgeons of giving the local anesthetic infiltration of scalp before craniotomy incision leading to an effective attenuation of hemodynamic perturbations, this technique is not without limitation.[4],[11] Firstly, the infiltration is so localized that the reapplication of pins at a different site requires re-infiltration again, which is not an uncommon event in neurosurgical practice. Secondly, this local anesthetic effect is short lived.[12],[13]

SNB involves blockade of the nerves that innervate the scalp, providing analgesia for a considerable period of time with the potential for postoperative effect. The idea of combining regional and general anesthesia has the potential for decreased intraoperative anesthetic requirements and attenuating anticipated hemodynamic responses in many patients.[5],[14],[15]

There is a paucity of literature that compares the efficacy of SNB using levobupivacaine against the intravenous fentanyl bolus followed by infusion in attenuating the hemodynamic response to skull pin application. Levobupivacaine used here for scalp block has a superior pharmacokinetic profile, and studies have demonstrated larger tolerated doses of inadvertent levobupivacaine compared with bupivacaine before the onset of CNS symptoms in humans.[16]

The most painful stages of craniotomy procedures are the application of a head-pin fixation device and scalp incision. Therefore, it is necessary to give additional analgesia to prevent the hemodynamic response manifested in the form of tachycardia and hypertension during these stages.[3] The SNB group showed a more effective attenuation of hemodynamic response by maintaining more stable intraoperative hemodynamics.

We observed that the variation in hemodynamics, in terms of HR at pin fixation was statistically significant. There was a statistically significant change in MAP between the groups during the intraoperative period (during pin fixation Group F [104.70 ± 9.18] and Group S [92.88 ± 6.92]). A significant reduction in intraoperative fentanyl requirements was also seen. Emergence from anesthesia was significantly longer in Group F (17.40 ± 4.65 min) as compared to Group S (8.50 ± 2.72 min). These findings are similar to previous studies, which were smaller in sample size.[17],[18],[19]

Since wide variations in hemodynamics are undesirable in patients undergoing craniotomy, minimizing hemodynamic perturbations remains one of the essential elements in the neuro anesthesia management of intracranial surgery. Taking this fact into consideration, our study involving the use of SNB provided smooth control in terms of maintenance of hemodynamic parameters, i.e., HR and MAP within 20% of baseline values as compared to the fentanyl group where additional pharmacotherapy was needed in order to avoid intraoperative hemodynamic surges. These findings were similar to the study done by Chowdhury et al., where episodes of diastolic hypertension occurred more frequently in the control group using saline as compared to 0.5% lidocaine group.[4]

We have compared SNB with iv fentanyl and found preoperative and postoperative NRS scores to differ significantly. None of the studies on the hemodynamic response has used intraoperative pain scoring during general anesthesia, which can help in more precise control of pain and hemodynamics. We found APPS scores between the groups to be varying with high significance during the intraoperative period, and it guided us in treating intraoperative pain and hemodynamics with high accuracy.

Arshad et al. compared the efficacy of lidocaine infiltration versus no infiltration for preventing the hemodynamic response associated with pin insertion and found that HR and MAP decreased after pin insertion in the infiltration group at 1 min after application of the pins; the difference between the groups was significant.[11] Though the response was similar to our present study, our study demonstrated reasonable control over the hemodynamics when the SNB was used.

The fear of complications like sedation, hypoventilation, miosis, seizures, and intracranial bleed has inhibited prescribing effective multimodal pain treatment for patients undergoing supratentorial craniotomy.[14] For these reasons, preincisional SNB in the present study has proven to be a useful technique by demonstrating a significant reduction in pain scores as compared to the fentanyl group postoperatively. The longevity of the preincisional administration of SNB will be dependent on the duration of surgery and the type of local anesthetic used.[16],[19],[20] In our study, in order to achieve the primary objectives, SNB performed before pin fixation may have the benefit of blunting hemodynamic responses to noxious stimuli such as head pin fixation, scalp incision, flap dissection, and craniotomy. The resulting reduction of intraoperative anesthetic and analgesic requirements would facilitate more smooth and early emergence.

In our study, the use of levobupivacaine mediated SNB showed a superior pharmacokinetic profile in terms of longer duration of the sensory block as suggested by reduced intraoperative analgesic requirements with smooth emergence and potential for postoperative effect and without symptoms or signs suggestive of either CNS or CVS sequelae (such as seizures, confusion, and hypotension). These facts were consistent with some previous studies.[19],[20]

The use of fentanyl infusion for intraoperative analgesia resulted in wide variations of blood pressure, increased use of intraoperative opioid and isoflurane, delayed emergence, and increased incidence of respiratory depression. Regional anesthetic techniques, especially the SNB, offer the advantage of providing analgesia without the deleterious adverse effects associated with systemic administration of opioids such as nausea, vomiting, sedation, and respiratory depression, delayed emergence, and increased hospital stay. In our study, the fentanyl group also did not show significant adverse effects.

There are certain limitations to our study. It was a single-center study with a relatively small cohort; hence results cannot be generalized. Moreover, our study population consisted of only one subset of patients, i.e., patients scheduled for supratentorial craniotomies. To assess the efficacy of SNB using levobupivacaine for attenuating the hemodynamic response, it should be administered to other surgical subsets too. Lastly, we have selected only ASA I and II patients, so the efficacy and side effects of the two drugs in high-risk patients could not be assessed.

  Conclusion Top

This study revealed that the technique of SNB using levobupivacaine as an adjuvant to general anesthesia acts as an effective and safe technique for attenuating pain and hemodynamic response to pin fixation and scalp incision in patients undergoing craniotomies for supratentorial tumors. It provides significant intraoperative hemodynamic stability with minimal possible surges, as measured by HR and MAP changes. The use of SNB provides adequate analgesia, as evidenced by a significant reduction in total intraoperative fentanyl, as is evident from the reduction in pain score. In addition to being generally, effective SNB with levobupivacaine has a limited adverse effect profile and needs less time for administration of the block.

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  [Table 1], [Table 2]


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