|Year : 2016 | Volume
| Issue : 2 | Page : 267-273
Percutaneous vertebroplasty under epidural anesthesia: comparative study versus local anesthesia
Alfred M Said1, Heba B El-Serwi1, Fady M Fahmy2
1 Department of Anesthesia, Ain Shams University, Cairo, Egypt
2 Department of Orthopedics, Ain Shams University, Cairo, Egypt
|Date of Submission||02-May-2015|
|Date of Acceptance||21-Jul-2015|
|Date of Web Publication||11-May-2016|
Heba B El-Serwi
7 El Shahid Ahmed Wasfi St., Almaza 11341, Cairo, 11341
Source of Support: None, Conflict of Interest: None
This study aimed to evaluate percutaneous vertebroplasty (PVP) under epidural (EPI) anesthesia and its effect on patients' and surgeons' satisfaction.
Patients and methods
Sixty-three patients undergoing thoracolumbar PVP were divided randomly as follows: the LA group received local anesthesia (LA) and the EPI group received EPI anesthesia as one pre-emptive shot of 8-10 ml plain levobupivacaine 0.25% (2.5 mg/ml). PVP involved an injection of 4-8 ml polymethlymethacrylate into each treated vertebra. Anesthetic outcome was defined as assessment of injection pain using a 10-point numeric rating scale, hemodynamic stability; efficacy of postoperative (PO) analgesia and patients' satisfaction were rated using the Iowa Satisfaction with Anesthesia Scale for monitored anesthesia care and surgeons' satisfaction was evaluated using a seven-point Likert scale. Surgical outcome was defined as patients' disease-related pain levels assessed before and 24-h PO using numeric rating scale.
EPI anesthesia provided multiple advantages over LA; injection pain and anxiety-induced tachycardia and hypertension were significantly lower. EPI anesthesia allowed multiple-level PVP in the same setting with a single anesthetic injection; this was reflected as significantly higher surgeon and patient satisfaction. PO pain was significantly lower with EPI versus LA, with less need for PO analgesia. Both groups showed PO improvement in their disease-related pain.
EPI anesthesia is a safe and effective alternative for LA during PVP. It allowed multiple-level corrections in the same setting, adequate hemodynamic stability and PO analgesia, and resulted in significantly higher surgeon and patient satisfaction, especially those who had one-setting multiple-level corrections.
Keywords: epidural, local anesthesia, percutaneous vertebroplasty, satisfaction rate
|How to cite this article:|
Said AM, El-Serwi HB, Fahmy FM. Percutaneous vertebroplasty under epidural anesthesia: comparative study versus local anesthesia. Ain-Shams J Anaesthesiol 2016;9:267-73
|How to cite this URL:|
Said AM, El-Serwi HB, Fahmy FM. Percutaneous vertebroplasty under epidural anesthesia: comparative study versus local anesthesia. Ain-Shams J Anaesthesiol [serial online] 2016 [cited 2019 Jan 19];9:267-73. Available from: http://www.asja.eg.net/text.asp?2016/9/2/267/182267
| Introduction|| |
Vertebral compression fractures (VCFs) constitute a major healthcare problem not only because of their high incidence but also because of their direct and indirect negative impacts on both patients' health-related quality of life and costs to the healthcare system .
The lifetime risk of a vertebral body compression fracture is 16% for women and 5% for men. Approximately 26% of women aged above 50 years and 40% of women aged above 80 years are reported to have sustained VCF. A prevalent VCF is common in old men, but has low clinical relevance. The incidence of osteoporotic fractures is anticipated to increase four-fold worldwide in the next 50 years [2,3].
About one-third to three-fourth of patients who sustain VCF develop chronic back pain, which can be attributed to pseudoarthrosis or osteoporotic spinal deformity, such as kyphosis or kyphoscoliosis, and the degree of kyphosis correlates well with the patient's physical function. Risk of further fracture, compression of the spinal cord, mental well-being, and pulmonary function are complications, any of which can contribute toward an increased mortality rate. Statistically significant and marked differences in life expectancy were observed between the treated and the nontreated cohorts in the Medicare population [4,5].
Irrespective of etiology, treatment for VCF has been largely conservative and directed toward pain control, usually consisting of narcotic analgesia, bed rest, and back bracing. However, anti-inflammatory drugs and certain types of analgesics are poorly tolerated by elderly patients and bed rest can lead to further bone demineralization, which may predispose to future fractures as well as thromboembolic complications and pneumonia. Furthermore, surgical fixation often fails because of the poor quality of osteoporotic bone and because of the risks of open surgery in this predominantly elderly population; these procedures are generally limited to cases in which there is concurrent spinal instability and/or neurologic deficit [6,7].
The vertebroplasty procedure was first performed in 1984 for the treatment of a hemangioma at the C2 vertebra. Kyphoplasty was first performed in 1998 and includes vertebral height restoration in addition to the use of inflation balloons and high-viscosity cement. Both vertebral augmentation procedures are efficacious, safe, and long-lasting procedures. Moreover, both are effective in providing pain relief and improvement in functional capacity and quality of life after the procedure .
Vertebral reinforcement techniques, such as percutaneous vertebroplasty (PVP) and kyphoplasty, are minimally invasive procedures used in the treatment of fractured or collapsed vertebras. However, the anesthetic techniques used during these procedures are diverse, with variable results . The current study aimed to evaluate the outcome of PVP under epidural (EPI) anesthesia and its effect on patient and surgeon satisfaction.
| Patients and methods|| |
The current prospective comparative study was carried out at the Departments of Anesthesia and Orthopedics at Ain Shams University Hospitals and some private hospitals from January 2011 to June 2014. After approval of the study protocol by the Local Ethical Committee and obtaining patients' written fully informed consent, patients assigned to thoracolumbar PVP for the treatment of back pain associated with osteoporotic body compression fracture were included in the study.
Patients were divided randomly using sealed envelopes prepared by a blinded assistant and chosen by patients into two groups: group LA included patients assigned to receive local anesthesia (LA) and group EPI included patients assigned to receive EPI anesthesia as only one pre-emptive shot EPI injection of plain levobupivacaine 0.25% (2.5 mg/ml).
All patients were evaluated in terms of age, sex, weight, and height. BMI was calculated and duration of disease-related pain was determined. Clinical examination included determination of ASA grade and only patients of grades I and II were included in the study. Number of compressed vertebrae and the percentage of maximum compression were determined.
All patients were shifted to the operating room premedicated with 2 mg intravenous midazolam and after standard monitoring by noninvasive monitoring of blood pressure, heart rate, and peripheral oxygen saturation (SpO 2 ), lactated Ringer's solution was started. Patients were administered an intravenous prophylactic broad-spectrum antibiotic before the start of the procedure.
In the EPI group, patients were positioned in the lateral decubitus and after identification of the EPI space using the loss of resistance technique, a 20-G EPI catheter (Perifix 401; B. Braun Melsungen AG, 34209 Melsungen, Germany) was inserted through an 18-G Tuohy needle that was placed at 1-2 interspace above the level of the vertebra to be operated upon and advanced 3-5 cm into the EPI space; subsequently, 8-10 ml of plain levobupivacaine 0.25% (2.5 mg/ml) was administered. Then, patients were placed in a prone position after 10 min.
The vertebroplasty procedure was performed as described by Jensen et al.  Patients were placed in a prone position on the operating table. The involved vertebrae were identified fluoroscopically and the overlying skin was prepared and draped. In the LA group, LA was applied to the skin and deep structures, including the periosteum of the bone at the intended site of entry using 8 ml of bupivacaine (0.25). A total of 4-8 ml of polymethlymethacrylate was injected into each treated vertebral body.
(1) Injection pain for both local and EPI injection was assessed using a 10-point numeric rating scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst pain imaginable. NRS was chosen as it is more practical than the graphic visual analogue scale, easier to understand for most individuals, and does not need clear vision, dexterity, paper, and pen [11,12].
(2) During the perioperative and postoperative (PO) period, standard monitoring including heart rate and systolic, diastolic, and mean arterial pressure was performed after induction of anesthesia (T0) and every 5 min up to 15 min and then every 15 min till the end of surgery. Hypotension, defined as a reduction of the systolic blood pressure greater than 20%, was treated with a rapid infusion of lactated Ringer's solution and intravenous boluses of ephedrine. Bradycardia was treated by intravenous atropine sulfate 0.6 mg bolus. To avoid hypothermia during the operative period, the patients received prewarmed fluids.
(3) Efficacy of PO analgesia, throughout the immediate 12 h PO, was determined by evaluation of pain NRS scores and requirement of rescue analgesia, which was provided as intramuscular tenoxicam 20 mg.
(4) Patients' satisfaction regarding efficacy of anesthesia was assessed for all patients using the Iowa Satisfaction with Anesthesia Scala (ISAS) for monitored anesthesia care . ISAS was documented as a valid tool for Arabic-speaking patients by Baroudi et al.  Patients respond to 11 statements by placing a mark along a six-choice vertical response column; each had numerical correspondence as follows: disagree very much (=1), disagree moderately (=2), disagree slightly (=3), agree slightly (=4), agree moderately (=5), and agree very much (=6). The scores were reversed in negative questions. The mean of their responses to each of the 11 statements yields a single number, which is a quantitative measure of patients' satisfaction with their monitored anesthesia care.
(5) Surgeons' satisfaction in terms of performing PVP under local or EPI anesthesia was evaluated for each patient separately using the seven-point Likert scale (1 = strongly disagree, 7 = strongly agree) ; therefore, there were 30 evaluation sheets for surgeons' satisfaction for each group.
(1) Patients' disease-related pain levels were assessed before vertebroplasty and at 24 h PO using NRS.
Sample Power was calculated according to Kraemer and Theimann  using their proposed figure, which showed that the sample size for 60% power would require an N of 31/group and 80% power would require an N of 51/group. This hypothesis was documented by Murphy and Myors . Considering that patients assigned for PVP and fulfilling inclusion criteria are not frequent; so from a standard nomogram, a sample size of 31 patients per group was determined to be sufficient to confer the trial greater than 60% power to detect a difference at the 5% significance level. The data obtained were presented as mean ± SD, ranges, numbers, and ratios. Results were analyzed using a paired t-test for within-group variability and the Wilcoxon ranked test for unrelated data (Z-test) and c2 -test paired t-test for variability between groups. Statistical analysis was carried out using the SPSS (version 15, 2006) for Windows statistical package (SPSS Inc., 233 South Wacker Drive, Chicago, IL). P value less than 0.05 was considered statistically significant.
| Results|| |
The study included 63 patients, 14 men and 49 women, mean age 65.1 ± 7.4; range: 42-76 years. Only five patients were of average weight, 21 patients were overweight, and 37 patients were obese to varying extents. Forty-eight patients were ASA I and 15 patients were ASA II. The duration of disease-related pain was 3.3 ± 0.8, range: 2-5 years. Eighty-five vertebrae were compressed for a mean number of 1.4 ± 0.6; range: 1-3 vertebrae. The maximum degree of compression was 56.5 ± 11.9, range: 25-75%. There was a nonsignificant (P > 0.05) difference between the groups studied in terms of enrollment data as shown in [Table 1].
A local injection of anesthesia induced significantly higher heart rate and blood pressure measures at 15 min compared with preoperative measures and corresponding measures of the EPI group. However, the other measures at 30, 45, and 60 min were nonsignificantly higher compared with preoperative measures. In contrast, EPI anesthesia induced significantly lower heart rate and systolic blood pressure measures throughout the operative time compared with preoperative measures. EPI anesthesia induced significantly lower heart rate measures at 15, 30, and 45 min, but nonsignificantly at 60 min compared with LA. Moreover, EPI anesthesia significantly reduced diastolic blood pressure at 15 min, but nonsignificantly later on and so significantly lowered mean arterial pressure at 15 min and nonsignificantly thereafter compared with LA [Table 2].
|Table 2 Hemodynamic data of the studied groups measured throughout the operative time|
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The duration of injection was nonsignificantly shorter for EPI anesthesia compared to LA injection. Also patients who need at least 10 min for injection of LA was nonsignificantly higher compared with an EPI injection. The severity of injection pain was significantly lower with an EPI versus a local injection, with a significantly higher frequency of patients among lower NRS scores in the EPI group versus the LA group [Figure 1]. Nine patients required additional intraoperative analgesia with significantly lower frequency in the EPI group versus the LA group [Table 3].
|Figure 1: Median [interquartile range (IQR)] of the numeric rating scale (NRS) score for injection pain|
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Surgeons' satisfaction scoring was significantly (P = 0.011) when working under EPI anesthesia than under LA [Figure 2]. In terms of patients' satisfaction scoring, the mean ISAS score was significantly higher (P = 0.018) in group EPI compared with group LA [Figure 3]. Eleven patients in the EPI group had multiple-level PVP and eight patients found the same-setting correction very satisfactory and three patients found it satisfactory.
|Figure 2: Median [interquartile range (IQR)] of surgeons' satisfaction score by type of anesthesia provided|
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|Figure 3: Median [interquartile range (IQR)] of patients' satisfaction score by type of anesthesia provided|
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The 2 groups of patients showed improvement in their disease-related pain manifested as a significantly lower PO pain score compared with preoperative scores, with a nonsignificant difference between both study groups despite being in favor of the EPI group [Figure 4] and [Figure 5].
|Figure 4: Median [interquartile range (IQR)] of preoperative back pain severity documented by patients of both groups|
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|Figure 5: Median [interquartile range (IQR)] postoperative back pain severity documented by patients of both groups|
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| Discussion|| |
EPI anesthesia provided multiple advantages over LA during PVP; first, injection pain was significantly lower with EPI than local injection and this was reflected as significantly lower NRS pain scores in the EPI group. Second, the sympatholytic effect of EPI anesthesia reduced anxiety-induced tachycardia and hypertension. Third, EPI anesthesia allowed PVP for multiple levels in the same setting with a single anesthetic injection, and thus spared the need for multiple injections, exposure to a high dose of locally injected anesthetics, and postponement of the other levels for another setting, thus reducing the cost and patients' days off. Surgeons' satisfaction rate was significantly high and also all patients who had multiple level PVP were satisfied being operated upon in the same setting and this relived their apprehension of being still in need for another setting. Fourth, PO pain was significantly lower in the EPI group compared with the LA group, and thus reduced the need for PO analgesia.
These advantages provided are in agreement with those reported for EPI anesthesia for spinal surgeries, wherein Nicassio et al.  found that EPI anesthesia enabled a reduction in anesthetic and surgical times, anesthetic complications, and, consequently, the hospitalization period for patients undergoing lumbar microdiscectomy compared with general anesthesia. Schroeder et al.  reported that EPI anesthesia for anterior lumbar interbody fusion is potentially beneficial compared with general anesthesia, showing significant reductions in NRS PO pain scores and PO mean arterial pressure, and patients needed significantly fewer opioids intraoperatively and postoperatively.
Yoshikawa et al.  evaluated the feasibility of EPI anesthesia for percutaneous endoscopic lumbar discectomy in comparison with LA and general anesthesia and found that in the EPI anesthesia group, no patient required a change of the anesthetic technique or administration of analgesics during surgery; patients received a smaller amount of LA but spent a longer time in the operating room compared with those in the LA group. In a similar comparative study, Düger et al.  documented that although spinal, EPI, and combined spinal-EPI anesthesia are adequate and effective for lumbar laminectomies, EPI and combined spinal-EPI anesthesia techniques are more effective for PO analgesia and sedation, with fewer side effects.
Khajavi et al.  found combined EPI/general anesthesia for patients who underwent one-level or two-level of laminectomy/discectomy to have some advantages over general anesthesia in reducing blood loss and anesthetic medication during the operation and it was also more effective for pain control, with a lower pain score and total analgesic requirement and fewer complications during the PO period. Recently, Akakin et al.  evaluated the effectiveness and safety of EPI anesthesia in elective lumbar microdiscectomy surgery and found it to be a safe and effective method; all patients were satisfied and reported that they would consider EPI anesthesia in future similar surgeries.
Unfortunately, there is only one article in the literature by Cuchillo-Sastriques et al. , who performed vertebroplasty and kyphoplasty in six patients using subarachnoid anesthesia with a hypobaric technique and reported satisfactory hemodynamic stability and analgesia in all six patients.
To our knowledge, the current study is the first comparative study on the outcome of vertebroplasty under EPI versus LA. EPI anesthesia was found to be a safe and effective alternative for LA during vertebroplasty. EPI anesthesia enabled multiple-level corrections in the same setting and provided adequate hemodynamic stability and PO analgesia. EPI anesthesia resulted in significantly higher surgeons' and patients' satisfaction, especially those who underwent one-setting multiple-level corrections.
Alfred M. Said: concept, design, literature search, clinical studies, and manuscript preparation. Heba B. El-Serwi: design, literature search, clinical studies, data acquisition, and manuscript review. Fady M. Fahmy: concept, clinical studies, data acquisition and manuscript review. Guarantor: Alfred M. Said.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3]