|Year : 2015 | Volume
| Issue : 4 | Page : 608-612
A comparative study between levobupivacaine and hyperbaric bupivacaine in spinal anesthesia for ambulatory brachytherapy for carcinoma of the cervix
Ismail M Abdelgawad Ahmed MD , Tarek Abdelsalam, Ahmad Zedan
Department of Anesthesia, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
|Date of Submission||05-May-2014|
|Date of Acceptance||02-Jul-2014|
|Date of Web Publication||29-Dec-2015|
Ismail M Abdelgawad Ahmed
Flat 41, 48 Manial Street, 35855 Cairo
Source of Support: None, Conflict of Interest: None
This study aimed to assess the clinical efficacy of levobupivacaine in spinal anesthesia for day-case brachytherapy for carcinoma of the cervix.
A prospective, randomized, double-blind study was conducted at the Anesthesia Department of Al-Azhar University Hospitals over a period of 6 months.
Patients and methods
Between July 2013 and January 2014, 40 female patients were included in the study after approval of the Local Ethics Committee of Anesthesia and Intensive Care Department of Al-Azhar University. Informed consent was taken from the patients who were randomized into two groups. Bupivacaine group, which included 20 patients who received intrathecal 7.5 mg of 0.5% hyperbaric bupivacaine; and levobupivacaine group, which included 20 patients who received intrathecal 7.5 mg of 0.5% levobupivacaine. About 25 mg fentanyl was added to the local anesthetic solution in both groups through the L3/L4 interspace. The upper level of sensory blockade, two-segment sensory regression, S2 regression, side effects of the local anesthetic used, urination, ambulation, and the duration of hospital stay were assessed.
There were no significant differences between both groups regarding the level of sensory blockade, the onset of sensory blockade to the T10 dermatome, and side effects of the local anesthetic. The time to two-segment regression, S2 regression, ambulation, and the duration of hospital stay were significantly shorter in the levobupivacaine group (P < 0.05).
The mixture of 7.5 mg of 0.5% levobupivacaine+25 mg fentanyl given intrathecally was more effective as it provided sensory and surgical blockade with minimal side effects and early home discharge in ambulatory brachytherapy for carcinoma of the cervix compared with 7.5 mg of 0.5% hyperbaric bupivacaine+25 mg fentanyl.
Keywords: ambulatory brachytherapy, levobupivacaine, spinal anesthesia
|How to cite this article:|
Abdelgawad Ahmed IM, Abdelsalam T, Zedan A. A comparative study between levobupivacaine and hyperbaric bupivacaine in spinal anesthesia for ambulatory brachytherapy for carcinoma of the cervix
. Ain-Shams J Anaesthesiol 2015;8:608-12
|How to cite this URL:|
Abdelgawad Ahmed IM, Abdelsalam T, Zedan A. A comparative study between levobupivacaine and hyperbaric bupivacaine in spinal anesthesia for ambulatory brachytherapy for carcinoma of the cervix
. Ain-Shams J Anaesthesiol [serial online] 2015 [cited 2020 Mar 29];8:608-12. Available from: http://www.asja.eg.net/text.asp?2015/8/4/608/172750
| Introduction|| |
Spinal anesthesia can be suitably performed for a variety of day-stay (ambulatory) surgical procedures. The duration of hospital stay and discharge to home is a corner stone. This may impact patient satisfaction and also human and financial resource constraints within a hospital. The dose and the type of local anesthetic (LA) that is used needs to be tailored specific to the nature (site) and the duration of the intended surgery  .
Day-stay surgical patients undergo insertion of an intracervical (Smit sleeve) stent that is 8 mm in diameter. The stent facilitates subsequent introduction of an applicator that is necessary to perform brachytherapy. The procedure also involves probing (sounding) the fundus of the uterus, which requires a spinal block up to and including the T10 dermatome level.
In the past few years, the lower toxic effects of ropivacaine and levobupivacaine on the cardiovascular and the central nervous systems have been introduced into clinical practice , . In recent years, levobupivacaine, being an equipotent isomer of bupivacaine, emerged as a safer alternative for regional anesthesia compared with its racemic parent. Yet, levobupivacaine has not entirely replaced bupivacaine in clinical practice; however, a few studies suggest that low-dose levobupivacaine (4 mg and onwards) is clinically effective ,,, .
The clinical profile of spinal bupivacaine and levobupivacaine has been evaluated in volunteers  and clinical studies ,,, , and they were found to provide comparable surgical sensory block with similar adverse side effects and were effective in patients undergoing lower abdominal surgery, day-case gynecology procedures, inguinal hernia repair, and lower limb procedures  .
The regression of motor block was significantly more rapid after levobupivacaine and ropivacaine compared with bupivacaine in a study by Casati et al. , which may be advantageous for early ambulation after day-case surgery.
Lipophilic opioids added to LA can adapt the spinal anesthetic to a specific type and duration of surgery. Using the synergistic analgesic effect of an opioid, it is possible to create adequate spinal anesthesia for surgery with normally subtherapeutic doses of LA. Therefore, intrathecal administration of such a combination improves the anesthesia quality, prolongs sensory blockade without prolonging motor block, and also reduces LA requirements  .
Traditionally, the dose of levobupivacaine used for spinal anesthesia is 15 mg. This dose provides an adequate sensory and motor block for most surgical procedures, lasting approximately up to 6.5 h. An up-and-down sequential design study recommends a minimum effective LA dose of levobupivacaine of 11.7 mg  . Smaller doses (i.e. 5-10 mg) have been used in ambulatory surgery, and allow a more rapid recovery and subsequent discharge home. The addition of fentanyl 15 mg demonstrates a sparing effect on the requirement of levobupivacaine, while maintaining excellent clinical efficacy with less hemodynamic variation  .
This study was undertaken to compare an intrathecal low dose of levobupivacaine with an intrathecal low dose of hyperbaric bupivacaine (with fentanyl being added to both of them) to determine as to which is more suitable for spinal anesthesia for brachytherapy (immediate proximity radiotherapy) for carcinoma of the cervix.
| Patients and methods|| |
This prospective, randomized, double-blind study was conducted at the Anesthesia Department of Al-Azhar University Hospitals over a period of 6 months from July 2013 to January 2014. The study was conducted after approval from the Local Ethics Committee of Anesthesia and Intensive Care Department of Al-Azhar University and informed written consent from the patients were obtained. Patients attending the Radiotherapy Clinic who were scheduled for brachytherapy for carcinoma of the cervix were included in the study.
Coagulopathy, hypersensitivity to LAs or opioids, infection at injection sites, patients' refusal for regional anesthesia, and other contraindications to spinal anesthesia were parameter for exclusion from the study.
Forty patients were randomized by sealed envelopes into two equal groups: the bupivacaine group, which received intrathecal 7.5 mg of 0.5% hyperbaric bupivacaine, and the levobupivacaine group, which received intrathecal 7.5 mg of 0.5% levobupivacaine. Fentanyl 25 mg was added to the LA in both groups through the L3/L4 interspace.
Before performing spinal anesthesia, an 18-G cannula was inserted for intravenous access and standard monitoring (pulse oximeter, noninvasive blood pressure, and an ECG) was applied. Ringer acetate solution (500-1000 ml) was administered. Intravenous midazolam (0.03 mg/kg) was given to all patients. The baseline systolic blood pressure was calculated as the mean of two systolic blood pressure measurements taken at rest.
Spinal anesthesia was administered using a 25-G Quincke spinal needle (Exelint Int.R, USA) in the sitting position through the L4/L5 interspace by a complete aseptic technique. Once free flow of clear cerebrospinal fluid was demonstrated, the solution was injected slowly. All patients remained sitting for 2 min after completion of the injection, and then repositioned in the lithotomy position for surgery. An anesthetist blinded to the treatment group of the patient was responsible for patient monitoring and clinical data collection for the study. Blood pressure was measured every 5 min after induction of anesthesia. A decrease in the systolic blood pressure to less than 20% of the mean baseline value was treated with 5 mg ephedrine intravenous and the dose was repeated as necessary.
When a sensory block to at least the T10 dermatome had been achieved, the patient was asked to grade the quality of anesthesia (sensation). Their description at the start of the procedure was classified into one of the four groups: 1, complete absence of any sensation; 2, sensation of motion only; 3, mild discomfort, but declines offer of additional analgesia; 4, patient asks for additional analgesia or is in bad need for it. If the patient fell into groups 1-3, the quality of pain control was deemed to be adequate, and the surgical procedure was continued without giving any supplemental analgesia or converting to general anesthesia. However, if the patient experienced discomfort or pain, and either requested or agreed to have additional pain relief upon being offered it, or was in obvious need of additional analgesia (group 4), then general anesthesia was administered.
The onset time of sensory or motor blockade was defined as the interval between intrathecal administration and the time to achieve a T10 level block or a Bromage score of 3, respectively. The duration of sensory blockade was defined as the interval from intrathecal administration to the point of complete resolution of the sensory block as manifested by the requirement of supplementary 'rescue' analgesia.
The dermatomal level of the sensory block in the present study was evaluated by complete loss of sensation to ice. It was based on the reliability and ease of application of this method. The level of sensory block was assessed every 5 min until the level of the block remained constant for three consecutive readings. Thereafter, the level was assessed every 10 min until the sensory block had regressed at least two dermatomes, and then every 15 min until all of the hospital discharge criteria (regression of the sensory block to the S2 dermatome, the ability to walk unaided, and the ability to void urine) had been met.
The following data were recorded and analyzed: the higher level of sensory dermatome and the time needed to reach it, the degree of motor blockade measured at the time of peak sensory blockade by the modified Bromage scale [Table 1]  , patient satisfaction measured by a visual analogue scale from 0 to 10 (depending on the quality of analgesia and the degree of motor block), the time needed to discharge the patient from the operative room to the recovery area (depending on the sensory level at or below the T10 dermatome). Nausea and/or vomiting, pruritus, dizziness, time to S2 regression, ambulation without assistant and urination were also assessed and recorded.
Patients were followed to determine the occurrence of any complications at the clinic visit if they had any pain that did not relate to the operative site, specifically in the thighs or the lower limbs, (transient neurological symptoms) or related to a postdural puncture headache.
Statistical analysis was performed using the computerized statistical package for the social sciences (SPSS, version 17; SPSS Inc., Chicago, Illinois, USA) for Windows. This study including 40 patients depending on the inclusion and exclusion criteria described previously, and this number represented nearly a fourth of the patients attending the hospital during the study period (between July 2013 and January 2014) [40 of 160 (25%) patients attending this clinic during the study period because the work was conducted only on 2 days/week and the high cost of drugs used]. Continuous data are described as means ± SD and analyzed using the Student t-test, followed by a two-sample Student's t-test for intergroup comparisons. Categorical data are reported as numbers and percentages and were analyzed using the c2 -test as appropriate. P values less than 0.05 were considered to be statistically significant.
| Results|| |
Between July 2013 and January 2014, a total of 40 adult female patients were enrolled in the study and randomly assigned equally into one of the two groups. The two groups were comparable with respect to age, weight, height, and the ASA classification [Table 2]. All spinal blocks performed in both groups were successful.
There were no significant differences between the two groups in terms of the highest level of sensory block and the maximum motor blockade score that was achieved [Table 3].
The time to reach two-segment regression, S2 regression, ambulation, urination, and the duration of hospital stay were all significantly shorter in the levobupivacaine group (P<0.05 for all recovery parameters; [Table 4].
|Table 4 Postoperative anesthetic recovery and home discharge times for patients|
Click here to view
There were no symptoms of nausea, vomiting, or pruritus in any of the patients. On direct questioning, only one of the 20 patients in the bupivacaine group had dizziness. One patient in each group had symptoms suggestive of a postdural puncture headache, which improved with conservative management. There were no recorded symptoms of transient neurological deficit in any of the patients.
| Discussion|| |
Spinal anesthesia can be suitably performed for a variety of day-stay (ambulatory) surgical procedures. The time of hospital stay and discharge to home is a corner stone. However, in the past, it was difficult to produce spinal anesthesia for ambulatory surgery due to the increase in the dose of long-acting LAs, which delay voiding and the ability to leave the hospital. In recent years, efforts have been made to improve spinal anesthetic techniques for ambulatory surgery by reducing the dose of LAs and introducing the use of additional spinal opioids to improve pain relief  .
The current study indicates that intrathecal administration of 25 mg fentanyl combined with low-dose levobupivacaine (7.5 mg) is well suited for outpatient procedures because it allows the rapid recovery of full motor power, sensory function, bladder function, and proper intraoperative and postoperative pain control due to a potential synergism between fentanyl and levobupivacaine  .
Hyperbaric bupivacaine was preferred to isobaric bupivacaine because of its more consistent and reliable subarachnoid spread and also its shorter duration of complete motor blockade. The synergistic effect of a small dose of intrathecal fentanyl with bupivacaine improves the quality of anesthesia, without the drug prolonging recovery from spinal anesthesia  .
Levobupivacaine is an interesting alternative to bupivacaine for spinal anesthesia. Levobupivacaine produces subarachnoid block with similar sensory and motor characteristics and recovery like bupivacaine. The onset of sensory and motor block is hastened with the use of hyperbaric levobupivacaine as compared with isobaric levobupivacaine  .
The regression of motor block occurs earlier with levobupivacaine and ropivacaine as compared with bupivacaine. Intrathecal administration of 15 mg of levobupivacaine provides an adequate sensory and motor block lasting for ~6.5 h. Smaller doses (i.e. 5-10 mg) are used in ambulatory surgeries; levobupivacaine can produce a differential neuraxial block with the preservation of motor function at low concentrations, which may be favorable for ambulatory surgery  .
Combining an intrathecal opioid with a LA might be beneficial for achieving a higher sensory block without the need to increase the dose of the LA and thus delay hospital discharge. Breebaart et al.  reported hospital discharge after 311 min with 10 mg levobupivacaine, and Casati et al.  reported hospital discharge after 261 min with 8 mg levobupivacaine. In the current study, hospital discharge was achieved after 285 min in the bupivacaine group compared with 234 min in the levobupivacaine group (P<0.05). The shorter time to discharge achieved with 7.5 mg levobupivacaine plus fentanyl was due to a faster regression of spinal block.
Breebaart et al.  evaluated bladder function with urinary bladder scanning after day-case spinal anesthesia with 10 mg levobupivacaine, 15 mg ropivacaine, or 60 mg lidocaine and reported that the incidence and the degree of micturition problems were not different with the three drugs. In the current study, there were no cases of urinary retention and no catheterization was required. Casati et al.  reported 255 min with 8 mg levobupivacaine. The current study showed that the time to urination was significantly shorter (218 min) in the levobupivacaine group compared with 260 min the bupivacaine group (P<0.05).
The current study showed no side effects such as pruritus, nausea, and vomiting comparing with other studies, which showed pruritus as a frequent side effect  .
The current study agrees with Haus et al.  who concluded that there were no recorded side effects (pruritus, nausea, and vomiting), except some patients complaining of dizziness and symptoms suggestive of a postdural puncture headache, which improved with conservative management.
The current study chose the dose of 25 mg of fentanyl as most studies have shown that this dose provides the maximum duration of postoperative analgesia with minimal side effects such as respiratory depression and pruritus. There was a strong relationship between higher doses, which was associated with increased analgesia and increased side effects such as pruritus. The ideal intrathecal opiate should have a rapid onset, a long duration of action, and minimal side effects, thus providing improved intraoperative and postoperative analgesia  .
| Conclusion|| |
The mixture of 7.5 mg of 0.5% levobupivacaine+25 mg fentanyl given intrathecally is more effective as sensory and surgical blockade with minimal side effects and early home discharge in ambulatory brachytherapy for carcinoma of the cervix than 7.5 mg of 0.5% hyperbaric bupivacaine+25 mg fentanyl.
| Acknowledgements|| |
The authors thank the Oncologist and Treating Radiotherapist colleagues for their co-operation and support in the protocol design.
Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4]