|Year : 2017 | Volume
| Issue : 1 | Page : 23-28
Comparison of epidural versus systemic analgesia for major surgeries in neonates and infants
NM Solanki, SR Engineer, P Vecham
Department of Anesthesia, B. J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India
|Date of Web Publication||8-Feb-2017|
Dr. N M Solanki
44-Devshrusti Bungalows-II, B/H Kena Bungalows, Motera Stadium Road, Motera, Sabarmati, Ahmedabad - 380 005, Gujarat
Source of Support: None, Conflict of Interest: None
Background and Aims: Postoperative analgesia in neonate reduces acute behavioral responses to pain. It also protects the developing nervous system from persistent sensitization of pain pathway and potential damaging effects of altered neural activity on central nervous system development. We compared the effectiveness of epidural versus systemic modes of analgesia for major surgeries in neonates and infants. Materials and Methods: This randomized, single center, prospective, controlled study was conducted in sixty patients, aged 1 day to 6 months, weighing 2–5 kg belonging to the American Society of Anesthesiology physical Grade II to IV, posted for major thoracic and abdominal surgery. After general anesthesia, in Group A, the epidural catheter was inserted through standard caudal epidural technique. Initial bolus of 0.125% bupivacaine (0.75 ml/kg) and postoperatively caudal infusion of 0.0625% bupivacaine (0.1 ml/kg/h) was given. Intraoperatively Group B received fentanyl (1–2 μg/kg) and paracetamol (10 mg/kg) intravenously and postoperatively paracetamol (10 mg/kg)/intravenous (IV) six hourly or pain score > 4. Postoperative pain was assessed using face, legs, activity, cry, and consolability pain scale and sedation score was assessed by using four-point sedation score for 48 h. Results: Patients in Group A remained hemodynamically stable except occasional bradycardia below 100 which was successfully managed with anticholinergics. There was less requirement of sevoflurane in the intraoperative period and good quality of analgesia. While in Group B, multiple and regular dosage of IV paracetamol was required to maintain adequate analgesia. Conclusion: Very efficient postoperative analgesia can be achieved via caudal epidural catheter in combination with general anesthesia compared to IV paracetamol in neonates and infants.
Keywords: Analgesia, epidural bupivacaine, intravenous paracetamol, neonate and infant, thoracic and abdominal surgeries
|How to cite this article:|
Solanki N M, Engineer S R, Vecham P. Comparison of epidural versus systemic analgesia for major surgeries in neonates and infants. J Clin Neonatol 2017;6:23-8
|How to cite this URL:|
Solanki N M, Engineer S R, Vecham P. Comparison of epidural versus systemic analgesia for major surgeries in neonates and infants. J Clin Neonatol [serial online] 2017 [cited 2020 Jul 12];6:23-8. Available from: http://www.jcnonweb.com/text.asp?2017/6/1/23/199757
| Introduction|| |
Continuous epidural analgesia has been shown to provide safe and effective analgesia in infants and children, without respiratory depression or prolonged apnea.
Use of general anesthesia with intraoperative regional anesthesia provides postoperative analgesia. Other benefits suggested are avoiding use of systemic opioids, and decreasing intraoperative requirement of inhalation agents.
Continuous caudal epidural anesthesia provides adequate duration of analgesia not only for lower limb and lower abdominal surgeries,, but also upper abdominal and thoracic surgery.,
Intravenous (IV) paracetamol becomes the most commonly used analgesic due to its relative safety, effective metabolism, wide dosage range, multiple routes for administration, and no effect on respiratory function.
| Methods|| |
After obtaining local Ethical Committee approval, written and informed consent was obtained from parents. This prospective, randomized, controlled, single center study was conducted in the pediatric surgical operation theater in our institute. Sixty neonates and infants of either sex, aged 1 day to 6 months, weighing 2–5 kg, American Society of Anesthesiology physical Grade II to IV, for major thoracic and abdominal surgery were included for the study. Patients suffering from local infection, neurological disorder, and history of allergic reaction to local anesthetics, sacral/vertebral abnormalities, and coagulation disorders were excluded from the study. During the preoperative visit, all patients were assessed.
Standard monitoring including electrocardiogram (ECG), noninvasive blood pressure measurement, pulse oxymetry, capnography, and temperature were applied. An IV access was secured and glycopyrolate inj. 0.004 mg/kg and ondensetron inj. 0.15 mg/kg were administered. All patients were induced with either inhalational agent sevoflurane (2%–7%) with oxygen or IV thiopental 5 mg/kg. To facilitate insertion of endotracheal tube, IV succinylcholine 2 mg/kg was given. Anesthesia was maintained with controlled ventilation using injection atracurium (0.5 mg/kg) with oxygen, nitrous oxide, and sevoflurane (0.6%–2%).
In Group A, for insertion of caudal epidural catheter, patients were placed in the left lateral position with knees, hips, and spine flexion. Under aseptic precaution caudal epidural space was located using 20-gauge Touhy needle (Portex Manipak, Hythe, Kent, UK) with “loss of resistance” technique and 24-gauge epidural catheter was placed in the epidural space. The length of the catheter to be kept inside was decided by measuring the length from caudal space to the required level of epidural block. Initial bolus 0.75 ml/kg of 0.125% bupivacaine was administered after negative aspiration for cerebrospinal fluid and blood with continuous ECG monitoring. Epidural catheter was secured by looping the catheter at the entry site and covering with a clean plastic dressing, then routed over the shoulder and fixed to the skin with micropore tape.
In Group B, fentanyl (1–2 µg/kg)/IV and paracetamol (10 mg/kg)/IV were administered. Neonates are at risk for hypoglycemia and dehydration. In neonates, perioperive fluid management in the first 48 h was with 10% dextrose with calcium gluconate at 60–80 ml/kg/day and after 48 h IsolytePwith or without calcium gluconate at 100–150 ml/kg/day. Neonates are extremely susceptible to hypothermia. Care was taken during transport and intra-operative period.
During surgery, adequate analgesia was assessed by hemodynamic stability, as indicated by the absence of an increase in heart rate and systolic blood pressure more than 15% compared with baseline value. No opioids were administered at any time during perioperative period in Group A. If surgery extended for longer than 75–90 min a top-up of half the original dose was given as required.
At the end of surgery residual neuromuscular block was antagonized with glycopyrrolate inj. 0.008 mg/kg and neostigmine injection 0.05 mg/kg intravenously.
Postoperative epidural analgesia was maintained by continuous infusion of 0.0625% bupivacaine at 0.1 ml/kg/h in Group A. After 6–8 h, rate was tapered according to the sedation and pain score and infusion was continued for 48 h. While in Group B, paracetamol 10 mg/kg intravenously was given six hourly or according to pain score, and the maximum dose 40 mg/kg/day was given.
The requirement of intraoperative concentration of sevoflurane was recorded at every 15 min. Heart rate, NIBP, SpO2, EtCO2, and temperature were recorded at every 15 min interval till the end of surgery and every hourly interval postoperatively.
Duration of surgery, duration of anesthesia and perioperative complications such as brady/tachycardia, hypo/hypertension, vomiting and urinary retention were recorded.
Postoperative sedation was assessed by using four point sedation score (0-spontaneous eye opening, 1-eye opening on speech, 2-eye opening on shake, 3-unarousable) and pain was evaluated by using face, legs, activity, cry, and consolability score (maximum score of 10) at 1 h interval for first 3 h and thereafter every 2 h interval till score >4 and rescue analgesic was given.
In this study, sample size was calculated using formula n = 4pq/E 2 which is based on Hardy-Weinbergg principle. In this formula, Pis the prevalence of pediatric surgery at our Institute. Sixty patients were allocated randomly into two equal groups (thirty patients/group). Collected data were presented as mean ± standard deviation, numbers and percentages as appropriate. Categorical variables were analyzed using Chi-square with yate's correction and Fisher's exact test (two-tailed) as appropriate. Continuous variables were tested using an unpaired student's t-test. Statistical calculations were carried out using Microsoft Office Excel 2010 and Graph Pad Prism 6.05 (GraphPad Software, Inc. La Jolla, CA, USA) Software. P <0.05 was considered statistically significant.
| Results|| |
No statistically difference was observed in both the groups regarding age, sex, weight, and duration of surgery [Table 1].
Majority of children in both groups underwent trachea-esophageal fistula (TOF) and laparotomy surgeries [Table 2].
In Group A, the caudal epidural space was identified in all patients on either the first or second attempt. No dural puncture or vascular puncture was noted. Difficulty in feeding the catheter was noted in only one patient. The level of blockage was satisfactory in all patients and there was no need to supplement any analgesic during intraoperative period.
Patients in Group A remained hemodynamically stable except occasional bradycardia below 100 which was successfully managed with anticholinergics. In Group B no significant change in heart rate and blood pressure [Table 3], [Table 4], [Table 5].
Initially, in both groups, concentration of sevoflurane 2% was set. In Group A, 15 patients were hemodynamically stable after 30 min with sevoflurane concentration of 1%, whereas in Group B, 22 patients were hemodynamically stable after 30 min with sevoflurane concentration of 2%. Thereafter, till the end of surgery 27 patients required 0.6% of sevoflurane concentration in Group A and in Group B none of the patients were hemodynamically stable with sevoflurane concentration of 0.6% [Figure 1] and [Figure 2].
Mean hourly pain score in Group A was below one, whereas in Group B, there was above 4 every six hourly and required multiple administration of paracetamol [Figure 3].
Immediate period in neonatal surgical unit sedation score was between one and two (eye opening on shake) in both groups and after 4 h sedation score was between zero and one (eye opening on speech) in Group A, whereas in Group B, there was change in sedation score and required additional doses of paracetamol [Figure 4].
All patients were extubated in the operating room within 10 min of the completion of the surgical procedure except one patient (TOF) in Group A who required mechanical ventilation. Postoperatively, bradycardia occurred in five patients in Group A compared to Group B [Figure 5].
All patients were observed for 48 h in neonatal surgical unit.
| Discussions|| |
The most important goals in surgical management of any neonates and infants are to provide adequate perioperative analgesia, minimal stress response, early and adequate respiratory function and minimal perioperative complications. This can be achieved by adequate analgesia with several techniques including inhalational agents, systemic opioids, and regional analgesia. In our study, we have compared epidural analgesia and systemic analgesia for achieving these goals.
Continuous epidural administration of bupivacaine 0.25% with general anesthesia in infants provided excellent intraoperative surgical conditions while limiting the requirements for inhalational anesthetic agents and eliminating the need of IV opioids. Caudal epidural anesthesia as an adjunct to general anesthesia blunts the deleterious physiologic effect of the postsurgical stress response and limiting the intraoperative requirements for inhalational anesthetic agents as well as parenteral opioids.
In our study is that we used 0.125% bupivacaine for intraoperative anesthesia and it was associated with less requirement of sevoflurane with faster recovery with favorable respiratory function.
Continuous epidural anesthesia with general anesthesia provides best balanced anesthesia with prolonged postoperative analgesia in urological, abdominal surgeries, and thoracic surgery.,,
The quality of analgesia obtained with continuous epidural bupivacaine 0.25% allowed the use of low concentrations of inhalation anesthetics and opioids, thus allowing a quick and safe awakening  and favorable effects on respiratory function., In addition, the ability to block neuroendocrine and metabolic response to surgical stimulation versus consequences makes it an excellent alternative for intraoperative use. Effective postoperative pain relief from epidural analgesia facilitates early recovery; rapid weaning from ventilators with reduced pediatric intensive care unit costs, reduced time spent in a catabolic state, and lowered circulating stress hormone levels.
Both systemic (e.g., drug toxicity, seizures, air emboli, nausea and vomiting) and local (e.g., neural damage) complications of continuous epidural anesthesia in children have been reviewed or reported in many previous publication.,,,,,,,
Technical problems with catheters are related to size, flexibility, tensile strength, and hole placement. The most common reason for premature discontinuation of epidural infusions were technical problems with catheters such as leakage and catheter occlusion.
The majority of complications associated with the use of epidurals are easily manageable and technical problems may decrease with experience hand.
In our study, there was no any catheter related problems, only bradycardia occurs in five patients of Group A which was successfully managed with anticholinergics. The incidence of vomiting, delayed recovery, and cardiac arrest were comparable in both the groups.
Bupivacaine toxicity may present in different ways. Eyres suggests that cardiac dysarrythmia or respiratory arrest is a more likely presentation in neonates and infants than convulsions. Neonates are at greater risk of bupivacaine toxicity in view of a lower level of the plasma protein α1-acid glycoprotein (AAG), albumin and lower bicarbonate reserves. However, AAG has a high affinity but low capacity for binding local anesthetic agents. Albumin on the other hand has a low affinity and greater capacity for local anesthetic. In the surgical neonate, the risk of toxicity remains with continuous infusion due to the low albumin levels., Long-term infusions do not cause a linear increase in plasma concentrations. It seems that once saturation of the local binding sites occur a rapid rise in plasma concentration is seen in some cases.,
The use of bupivacaine in concentrations between 0.125% and 0.25% gives excellent analgesia with few complications, such as excessive motor block and urinary retention.
However, during continuous epidural anesthesia, increasing plasma concentrations of local anesthetics may induce toxic adverse effects such as seizures, hypotension, and arrhythmia  and with increased experience in the use of continuous epidurals; technical problems may diminish.
Although our infusion regimen of 0.1 ml/kg/h is well within the dose range same as used by Bosenberg et al. for epidural analgesia for major neonatal surgery.
In the neonate, epidural analgesia may be indicated when the goal is early extubation (after TOF) or spontaneous ventilation (following congenital diaphragmatic hernia) to avoid barotraumas. These goals are relevant in developing countries where facilities are limited or stretched. Caudal anesthesia has become the most valuable adjunct to general anesthesia. Epidural catheters provide optimal analgesia when the tip of the catheter is placed at center of dermatomes affected by surgery. Safe blood levels of bupivacaine have been found after bolus injection of 1.5–2.0 mg/kg bupivacaine (0.6–0.8 ml/kg of 0.25% bupivacaine) followed by a continuous infusion of 0.2 mg/kg/h.
The use of regional anesthesia has shown to be safe and effective in common neonatal surgical emergencies. Use of continuous epidural anesthesia through the caudal route or caudal-thoracic advancement of the catheter for major thoracic and abdominal surgery offers good perioperative analgesia. Other observed benefits are early extubation, attenuation of stress response, early return of bowel function and reduction of general anesthesia-related postoperative complications. However, the risk of procedure-related and drug-related complications to the developing neural structure remains a serious concern.
Paracetamol was the drug used for systemic analgesic in view of its relative safety and effective metabolism by the infant and newborns. It could be safely used by different routes for perioperative analgesia. Although it was able to provide perioperative analgesia in our study group, was not significantly as epidural analgesia, as evidenced by the hemodynamic parameters, requirement of inhalational agent and pain scores. It required multiple and regular dosage during the postoperative period to maintain adequate analgesia.
| Conclusion|| |
We conclude that goals of analgesia in neonate and infant can be achieved well by continuous epidural catheter with good quality analgesia and attenuation of stress response. It is relatively simple and safe technique and threading of a catheter in caudal space is easy. In combination with general anesthesia, it provides satisfactory and balanced anesthesia for major surgeries with a low risk of complication with improved outcomes due to reduced need of anesthetic agents and postoperative ventilator support.
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Conflicts of interest
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]