|Year : 2017 | Volume
| Issue : 4 | Page : 188-194
Local anesthesia with sedation versus local anesthesia after general anesthesia for sinus surgery: a randomized trial
Mohamed T Ghanem MD 1, Ashraf Elmalt2
1 Department of Anaesthesia and Surgical Intensive Care, Zagazig University Hospital, Zagazig University, Zagazig, Egypt
2 Department of ENT, Zagazig University Hospital, Zagazig University, Zagazig, Egypt
|Date of Submission||02-Feb-2016|
|Date of Acceptance||03-May-2017|
|Date of Web Publication||11-Oct-2017|
Mohamed T Ghanem
Department of Anesthesia and Surgical Intensive Care, Zagazig University Hospital, Zagazig University, Zagazig
Source of Support: None, Conflict of Interest: None
Satisfaction for patients and surgeons during the perioperative functional endoscopic sinus surgery (FESS) remains an anesthetic challenge. We compared FESS under local anesthesia (LA) with monitored anesthesia care (MAC) and LA after induction of general anesthesia.
Patients and methods
One hundred patients scheduled for FESS were randomly recruited in this randomized controlled study. Fifty of them received LA after induction of general anesthesia (G group), while the rest of the patients received LA with MAC (M group). The outcome measures included satisfaction for the patient and surgeon, cost, surgical, and postoperative profiles.
Surgeon’s satisfaction was comparable in both groups, while patient’s satisfaction was significantly higher in the M group (P<0.001). Total operative time and time to postanesthetic care unit discharge were significantly shorter in the M group (70.65±4.3 and 13.3±2 vs. 95.8±4.4 and 47.3±5.8 min in the G group, respectively; P<0.001). Time to home discharge was also shorter in the M group (66.0±23.78 vs. 262.20±11.8 min in the G group; P<0.001). The overall costs were significantly lesser in the M group (234.0±5.3 vs. 836.15±41.25 Egyptian pounds in the G group; P<0.001).
In FESS, LA with MAC provided excellent patient’s experience with optimum surgical and postoperative profiles and lower cost.
Keywords: endoscopic sinus surgery, general anesthesia, local anesthesia, monitored anesthesia care
|How to cite this article:|
Ghanem MT, Elmalt A. Local anesthesia with sedation versus local anesthesia after general anesthesia for sinus surgery: a randomized trial. Res Opin Anesth Intensive Care 2017;4:188-94
|How to cite this URL:|
Ghanem MT, Elmalt A. Local anesthesia with sedation versus local anesthesia after general anesthesia for sinus surgery: a randomized trial. Res Opin Anesth Intensive Care [serial online] 2017 [cited 2018 Oct 20];4:188-94. Available from: http://www.roaic.eg.net/text.asp?2017/4/4/188/216446
| Introduction|| |
Functional endoscopic sinus surgery (FESS) has been considered as one of the most common ambulatory rhinologic procedures  that surgically manage sinusitis with a target to resume drainage of paranasal sinuses using nasal endoscopes . Generally, excess bleeding has been known to limit safety and efficiency of surgical manipulation of the sinuses ; therefore, it is an anesthetic priority to conduct a technique that optimizes surgical field, limits surgical risk, and raises the satisfaction for both patients and surgeons .
FESS can be performed under monitored anesthesia care (MAC) or general anesthesia (GA) under inhaled anesthesia or total intravenous anesthesia, using either laryngeal mask airway or endotracheal tube , or local anesthesia (LA) after induction of GA ,,,,. Comparisons of these different techniques have shown conflicting results in the literature .
With LA, the patient is conscious and able to denote any pain allowing surgeons to avoid surgical trauma , with hemodynamic stability and fewer incidences of postoperative complications . However, most of the surgeons are reluctant to operate under LA with sedation . Therefore, this study was conducted to compare LA with MAC and LA after induction of GA for patients undergoing FESS to test the hypothesis that LA could improve the surgical profile, enhance patient recovery, and maximizes satisfaction for both surgeons and patients.
| Patients and methods|| |
This prospective randomized trial was conducted in Zagazig University Hospital from the start of September 2013 to the end of August 2015. A total of 100 consecutive adult patients of both gender scheduled for FESS were enrolled in this study after obtaining written consent from each patient and approval from the local institutional review board. The advantages, disadvantages of GA and MAC, and how to use visual analog score (VAS) were explained preoperatively to all patients. Exclusion criteria included patients with bleeding, psychological or neurological disorders. Patients with uncontrollable hypertension, coronary artery disease, arrhythmia, hepatic or renal dysfunction, electrolyte or metabolic disorders, chronic obstructive pulmonary disease, severe asthma, anemia (hemoglobin concentration<10 mg/dl), and pregnancy were also excluded from the study.
Patients were randomly allocated using computer-generated random numbers into two equal groups. Fifty patients received LA after induction of GA in the first group (G group), and the remaining 50 patients received LA with MAC (M group). Patients in both groups were operated by the same surgeon and anesthesia either LA with MAC or after induction of GA was administered by the same anesthetist.
In both groups, patients were shifted to the anesthetic room where intravenous line was inserted, 3 mg, intravenous, midazolam was injected, and Ringer’s lactate solution infusion was started. Standard monitors were applied in the form of 5-lead ECG, noninvasive arterial blood pressure, and SpO2 measurement; then nasal packs soaked with 2% lignocaine with adrenaline were placed in both patient’s nostrils for surface anesthesia. After 20 min, patients were shifted to the operating room. GA was induced in the G group with intravenous 2.5 mg/kg propofol and 2 μg/kg fentanyl, and the tracheas were intubated with a cuffed endotracheal tube under muscle relaxation with 0.2 mg/kg cisatracurium. Anesthesia was maintained with isoflurane and cisatracurium maintenance dose 0.2 mg/kg every 50–60 min. following the initial dose. Positive pressure ventilation was used to obtain ETCO2 of 35 mmHg, then an oropharyngeal pack was inserted. After that, regional block was performed using supratrochlear, supraorbital, infraorbital, and nasociliary, and sphenopalatine nerve blockade. For blocking supratrochlear and supraorbital nerves palpitation was performed to find the supraorbital notch, the needle was advanced until paresthesia is felt, then an injection of 3 ml of LAs was given, then another 2 ml was injected at the point where the bridge of the nose meets the supraorbital ridge. For the nasociliary nerve, injection was performed 1.5 cm above the medial canthus at the medial orbital wall with the needle advanced 2–3 cm posteriorly and 2 ml of local was injected, and injection continued with needle withdrawal. For infraorbital nerve blockade, 3 ml was injected at the infraorbital foramen (located in a line between the pupil and the corner of the mouth just below the infraorbital rim). While, the sphenopalatine nerve was blocked through an oral injection of the greater palatine nerve, the greater palatine foramen is located at the posterior portion of the hard palate just medial to the gum line opposite the third molar. A needle was advanced 2 inches through the foramen and 3 ml was injected. According to the surgical need, if the posterior nasal cavity or the ethmoidal sinus needs to be anesthetized, the surgeon inserted a pledget socked in topical agents within the nasal cavity to decongest and anesthetize branches of the sphenopalatine nerve and anterior ethmoid nerves, respectively. After 5 min, LA was injected by the surgeon using a 25 G spinal needle at the posterior–inferior attachment of the middle turbinate to block the sphenopalatine nerve and at the axilla of the middle turbinate to block the anterior ethmoidal nerve. The LA used was lidocaine 1% with 1 : 200.000 epinephrine.
In the M group, 5 l/min of oxygen was administered to the oral cavity using a nasal cannula. Conscious sedation was applied in the form of midazolam 3–5 mg and fentanyl 50–100 µg. Nerve block and local infiltration were done by the anesthetist and surgeon, respectively, as was previously described in the G group. Intraoperatively, if patients experienced discomfort or mild pain, incremental doses of midazolam 1–2 mg and/or fentanyl 20 µg was administered to keep the patient calm and cooperative, while GA was induced for those who were uncooperative despite sedatives and or experienced uncontrollable pain and were excluded from the study. After completion of the regional and field anesthesia, a 20 min was allowed before starting surgical manipulation in both groups.
Intraoperatively, for all the study populations, the patient’s heart rate, mean arterial blood pressure (MAP), oxygen saturation, and ECG were monitored, and continued in the postanesthetic care unit (PACU). Also, a 15° reverse Trendelenburg position was applied to allow venous drainage. Fluid therapy included maintenance fluid plus the deficit replaced over the procedure and 3 ml of crystalloids for every milliliter of estimated blood loss. When MAP became less than 55 mmHg, a fluid challenge (lactated Ringer’s solution 3–4 ml/kg) and intravenous ephedrine (5 mg increments) were administered. Intraoperative bleeding was classified according to the following six-point scale : 0, no bleeding, a virtually bloodless field; 1, bleeding that was so mild that it was not a surgical nuisance; 2, moderate bleeding that was a nuisance but did not interfere with accurate dissection; 3, moderate bleeding that moderately compromised surgical dissection; 4, bleeding that was heavy but controllable and that significantly interfered with surgical dissection; and 5, massive bleeding that was uncontrollable and made dissection impossible. Scores less than or equal to 2 were considered to be optimal surgical conditions, While if the scale was above 2, the MAP of 60–70 mmHg was maintained using titrated doses of nitroglycerine infusion.
After completion of surgical resection, and surgical homeostasis was ensured, a nasal pack was inserted by the surgeon, patients in the G group received reversal of the muscle relaxant and tracheas were extubated after ensuring adequate homeostasis after removing the oropharyngeal pack. Patients in both groups were shifted to the PACU after being alert, and ensuring cardiopulmonary stability with patent airway. Then, patients were shifted from the PACU to the recovery area according to the modified Aldrete criteria  ([Table 1]), and discharged home after ensuring adequate homeostasis and ability to ambulate safely.
The satisfaction for both the patient and the surgeon, and recovery profile were our primary outcome. Recovery profile included pain, postoperative analgesic requirement in the first 24 h, time to discharge from PACU (time, the patient lapsed in the PACU), time to home discharge (time, the patient lapsed in the recovery area), and recorded complications in the form of bleeding, nausea, vomiting, dental numbness, sore throat, and headache. Pain intensity was evaluated with a 10-cm VAS (where 0 is defined as no pain at all and 10 as the worst possible pain) at 1, 6, 12, and 24 h postoperatively and received analgesics accordingly either in the hospital or through a telephone interview. Over the first hour postoperatively, patients received incremental doses of 25 mg of tramadol if the pain score was greater than 3 on VAS. If patients experienced pain in the following VAS scheduled evaluation, they received oral diclofenac 50 mg with a maximum of 200 mg in the first 24 h. Satisfaction of the surgeon (immediate postoperative) and patients (on the second day on the outpatient clinic visit) were reported using a Likert scale (1=not satisfied, 2=worse than expected, 3=as expected, 4=better than expected, 5=extremely satisfied).
Secondary outcome measures included intraoperative hemodynamic stability, and any recorded complications. Total operating time, surgical operating time, and the overall operative cost were also considered as the secondary outcome. Total operating time defined as the time from patient entrance to the theater till shift to the PACU. The surgical operating time is defined as the time from handling the endoscope till insertion of the nasal pack.
‘Statistical package for the social sciences’ (SPSS, version 20.0; IBM SPSS Statistics V20.0.0; USA) software was used for the analysis. According to the type of data, qualitative data is represented as number and percentage, and quantitative data as mean±SD. The following tests were used to test differences for significance; differences between frequencies (qualitative variables) and percentages in groups were compared by χ2-test, differences between parametric quantitative independent groups by t-test, and nonparametric by the Mann–Whitney test. P-value was set at less than 0.05 for significant results and less than 0.001 for highly significant results.
Sample size determination was based according to the data taken from both pilot study and our clinical experience at the beginning of the study. The satisfaction comparison between two groups with effect size 85% so sample size 88, 44 in each group with 10% refusal rate so, 100 patients were decided to be included in the study.
| Results|| |
Patient characteristics were comparable in both groups ([Table 2]). The total operative time was significantly longer in the G group populations (95.8±4.4 vs. 70.65±4.3 min in populations of the M group; P<0.001). Surgical time was comparable in both groups (41.1±4.9 in the G group vs. 42.2±5.1 min. in the M group). As regards the total operative cost, patients received LA with MAC cost 234.0±5.3, which is statistically much lesser than the patients who received LA after GA induction (836.15±41.25; P<0.001). The occurrence of bleeding that compromises the surgical field (≤2 on six-point scale) was comparable in both groups while no patients experienced heavy or massive bleeding (≥3 on six-point scale) in both groups ([Table 3]). There was significant statistical difference as regards the MAP and heart rate at 15, 30, and 45 min. between the patients of both groups ([Figure 1],[Figure 2],[Figure 3]).
|Figure 1 Patient’s flowchart demonstrating the number of patients eligible for inclusion into the study, enrollment, randomization, follow-up, and analysis.|
Click here to view
The results of this study showed greater patient satisfaction in the M group (P<0.001), while surgeon satisfaction was comparable in both groups. The intensity of postoperative pain expressed by the VAS and postoperative 24 h analgesic requirement were comparable among the study populations. The time to PACU discharge was significantly longer in the patients who received GA (47.3±5.8 vs. 13.3±2.2 min in patients received MAC; P<0.001). Also the time to home discharge was significantly longer in the G group (262.20±11.8 vs. 66.0±23.78 min in the M group; P<0.001). Apart from sore throat, there were no statistically significant differences in the postoperative complications between study groups ([Table 4]).
| Discussion|| |
FESS was initially performed under topical anesthesia with sedation; this allowed patients to signal of any kind of pain or discomfort, and surgeons to minimize any surgical complications . However, with the evolution of the advanced surgical techniques, the surgeons became able to extend their surgical resections, and GA became the preferred anesthetic choice to cope with those high surgical requirements . Moreover, due to its analgesic effect , LA after induction of GA eliminates the most important limitation of GA which is the intense intraoperative bleeding , and subsequently, avoids the need for high doses of narcotics and/or controlled hypotensive techniques with their inconvenient adverse effects .
There were no previous literature to the best of our knowledge that compared LA with MAC versus LA after GA induction; however, there were several studies that compared GA versus LA with MAC with conflicting results; most of these studies showed better surgical and recovery profiles with LA beside excellent patient and surgeon satisfaction ,,,. On the other hand, GA was shown to be preferable to LA in other trials ,. This controversy could be explained by the difference in the study design, the procedure performed, and by the extent of surgical resection. The key finding of our study is that when compared with LA after induction of GA for FESS, LA with MAC provided excellent patient satisfaction with better postoperative profile, optimal utilization of the operating room, and overall cost reduction.
We did not administer general anesthetics into the patients of the MAC group even with the maximal surgical dissection of the posterior part of the nasal cavity and the ethmoidal sinus. This could be explained by two important factors. The first is that we tailored LA with surgical needs; basically, we anesthetized the posterior nasal cavity by performing the sphenopalatine block through the oral greater palatine route, and if the surgery involved the posterior nasal cavity, and or the ethmoidal sinus, we performed not only topicalization but endoscopic-guided field infiltration along the branches of the sphenopalatine ganglion and the anterior ethmoidal nerves, respectively. The second factor is that, we delayed surgical manipulation 20 min after completion of regional and/or field anesthesia giving the tissues the full chance to be completely anesthetized.
In this study, the surgical bleeds did not compromise the extent of surgical dissections for all study populations. There were no patients who required induced hypotensive agents in either group. The use of topical, nerve blockade, and LA infiltration in our study populations was responsible for these two important findings. Submucosal LA infiltration has been also reported to minimize surgical bleeds in previous trials . On the other hand, Hassan and Ehab  evaluated the efficacy of sphenopalatine ganglion block (SPGB) combined with GA compared with GA alone; they found that the number of patients requiring esmolol was significantly higher in the nonblocking group.
The intensity of postoperative pain as was expressed by the VAS and rescue analgesics requirement were comparable in both groups. This could be attributed to the prolongation of the action of LA by adding epinephrine as a vasoconstrictor in the regional technique in both study groups. This was in agreement with previous trials that combined regional techniques with GA ,,,,, or performed LA alone . This effective pain management was reflected also on the lesser incidence of postoperative nausea and vomiting (PONV) even in patients who received GA. In previous trials, there were higher incidence of PONV in patients who underwent FESS under GA . This means that the PONV is more attributed to the presence of pain rather than to the effect of general anesthetics. On the other hand, there was a high incidence of sore throat in patients who received GA that was explained by the effect of endotracheal intubation and oropharyngeal pack and was considered as the most distressing complaint from the patients in this group.
The satisfaction of patients was significantly higher in patients who received MAC. Previous studies have reported that the satisfaction of patients was higher in LA with dexmedetomidine when compared with those who received GA during closed reduction of the nasal bone fracture  and septoplasty .
We refer the excellent results shown in patients who received LA to the following factors: the surgeon was willing to operate under regional anesthesia, preoperative counseling of patient, tailored LA techniques according to the surgical needs, and time lag between regional anesthesia and surgical manipulation permitted complete anesthesia of the surgical field. However, this study was without limitations; one important limitation is that it was impossible to blind the anesthetic technique. Also we did not extend the postoperative follow-up beyond the first 24 h, especially for those patients who developed sore throat after receiving GA.
We concluded that proper administration of LA with MAC for FESS optimizes surgical and postoperative profiles, raises the satisfaction for surgeon and patients, limits the overall costs, and optimizes operating room utility.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]