Brief Report - (2022) Volume 7, Issue 9
Received: 02-Sep-2022, Manuscript No. jcct-22-77825;
Editor assigned: 05-Sep-2022, Pre QC No. P-77825;
Reviewed: 07-Sep-2022, QC No. Q-77825;
Revised: 16-Sep-2022, Manuscript No. R-77825;
Published:
23-Sep-2022
, DOI: 10.37421/2577-0535.2022.7.182
Citation: Smiti, Yassine, Brahim El Ahmadi, Zakaria Belkhadir and Abdelilah Ghannam “Spinal Analgesia vs. Sedation, Brachytherapy, About
99 Case Reports.” J Cancer Clin Trials 7 (2022): 182.
Copyright: © 2022 Smiti Y, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The installation of brachytherapy applicator is a painful invasive procedure requiring anesthesia. In this study, we propose to compare intravenous anesthesia with spontaneous ventilation to an intrathecal analgesic protocol with local anesthetics and fentanyl. The main objective was to demonstrate the superiority of spinal analgesia in terms of per and postoperative analgesia during patient mobilization for CT scan. We performed a randomized clinical trial for women patients ASA 1 and 2 programmed for brachytherapy, and then we divided them into 2 groups. Group 1: Have benefited from intravenous anesthesia by propofol titration with fentanyl. Group 2: Benefited from spinal analgesia with bupivacaine 5 mg and fentanyl 25 mg. Then we collected demographic data, quality of anesthesia (Ramsay score for level of sedation, analgesia level by analogical visual scale score), hemodynamic and respiratory parameters, anesthetics events, duration of anesthetic acts, pain during mobilization. The period of our study was 6 months, from January to July 2019. A cohort of 99 patients (group 1=48, group 2=51). The results were similar for the preoperative demographic and medical data (age, Sex,comorbidities,the stage of the disease, chemotherapy and radiotherapy antecedent, surgery antecedent, preoperative pain, preoperative neurological examination). Anesthetic goals were achieved for 100% of the patients in first group and 98% in second group (n=50/51). They were 6 unwanted events in group 1 and 3 in group 2 (p=0.25), but no serious incident were reported, we didn’t achieve any conversion from spinal analgesia to general anesthesia and no drugs were added during the procedure. The induction time was 7.1 ± 2.2 min in group 1 and 12.1 ± 3.2 min in group 2 (p=0.045). The duration of awakening after anesthesia was 9.4 ± 5.8 min in group 1. The total duration of the procedure was 47.4 ± 8.7 min in group 1 versus 49.7 ± 8.4 min in group 2 (p=0.46). After the procedure the evaluation of the pain during mobilization at 5 minutes, 15 minutes and 30 minutes were respectively at 4/10-4/10-6/10 in group 1 and 0/10- 0/10-1/10 in group 2 (p=0.002).
Brachytherapy • Sedation • Women • Spinal analgesia
Brachytherapy is an intra-cavitary radiotherapy technique witch revolutionized the management of many cancers, especially cervical cancer. This procedure is painful, uncomfortable and requires patient cooperation [1]. It is therefore necessarily to perform under anesthesia. At the National Institute of Oncology, intravenous sedation has been the technique usually used to anesthetize patients during examination procedures, placement of applicators without any post-operative analgesic monitoring. In view of the desire to improve the quality of care, the aim was to set up anesthetic protocols to improve the situation. We have initiated a comparative feasibility study of spinal analgesia for local anesthetics and sedation as the gold standard technique. The aim was to determine whether spinal analgesia allows the applicator procedure to be performed and demonstrate the superiority of rachianalgesia in terms of postoperative analgesia during patient mobilization.
This is an open randomized clinical trial involving a population of women with cervical cancer requiring the placement of intra-cavity applicators for Brachytherapy. The exclusion criteria were patients who had refused one of the techniques, a coagulation disorder or an on-going anticoagulant treatment (patients being managed on an outpatient basis, the management of perioperative anticoagulants risks modifications of the protocol after randomization), chronic pain under treatment, spinal pathology, intracranial hyper pressure, known allergy to one of the anesthetics and psychiatric pathology [2]. The draw of the patients was realized. Group 1 was the Sedation group and group 2 was the spinal analgesia group. All the patients signed consent, elaborated and confirmed by ethics and deontology committee of the establishment.
• In group 1, intravenous anesthesia with conservative spontaneous ventilation was performed with an injection of 2 mg/kg of propofol and 1 μg/kg of fentanyl to obtain a ramsay score of 4 with spontaneous ventilation (EtCO2<40 mmHg). Maintenance was performed by reinjection of propofol and postoperative analgesia was provided by paracetamol.
• In group 2, a 5% hyperbaric bupivacaine rachianesthesia was performed by injection into the L4-L5 or L3-L4 spaces of 5 mg of bupivacaine associated with 25 μg of fentanyl. In order to achieve a Visual Analogue Scale score (VAS) of 0, a bromage score of 0 [3].
The parameters collected; Demographic: age, allergies, anesthetic antecedents, clinical anesthetic examination (APC), oncology treatments. Anesthetic; Constants at admission, pain assessed by visual analogue scale score, Bromage score. The chosen anesthetic technique, per and post operative evolution, Calculation of variations of hemodynamic constants, if more than 20% during the stages of anesthesia compare to the reference values at the admission of the patients in the operating room, The duration of the procedures: total duration (admission-exit), the duration of anesthetic induction (early induction-installation), waiting time before leaving the room (end of the operating procedure-leaving the room), The pain during the mobilisation of the patient after the procedure
The data was collected by the anaesthetists doctor. Processed by the SPSS 20 software. The quantitative variables were expressed as mean ± standard deviation or median. Qualitative variables were expressed in number (percentage). Contingency tables were used for the qualitative variables and for the coded quantitative variables. Chi2; and Fisher tests were used. The alpha risk was established at 0.05.
Descriptive study over a 17-week period, 145 patients was treated with Brachytherapy. Forty-six patients were excluded: ASA score >2 (n=5), the patient who refused rachianalgesia (n=6). Contraindication to rachianalgesia (n=35, anticoagulant treatment, herniated disc, secondary cerebral localization, chronic pain) (Figure 1).
Figure 1. Study flowchart.
The median age of the patients was 48 (30; 61). All patients were treated for curative purposes. Only 1 patient had localization secondary. 9 patients had been operated on previously, 3 for a cancerous disease (one for her uterine cancer). These patients had general anesthesia in the majority of cases (73.6%). Twenty-one patients had benefited from anesthesia for caesarean section or a non-surgical procedure (endoscopic, orthopaedic). A comparative study of these general population data was performed between patients in groups 1 and 2. These results are shown in Table 1. We note the absence of a statistically significant difference in the status and preoperative antecedents of patients in both groups (Table 1).
| Caracteristics | Group 1 n = 48 |
Group 2 n = 51 |
p |
|---|---|---|---|
| Age* (years) | 47,7 ± 2,8 | 48,8 ± 3,4 | NS |
| Weight* (kilogramme) | 68,4 ± 15,2 | 66,8 ± 12,7 | NS |
| Curative oncological statut** | 48 (100) | 51 (100) | NS |
| Secondary localization ** 0 ≥ 1 |
47 (98) 1 (2) |
51 (100) 0 |
NS |
Anterior surgery **
|
2 (4,5) 4 (9) |
1(2) 3 (6) |
NS NS |
Anterior anesthesia **
|
9 (19,1) 4 (8,5) |
11 (21,6) 6 (11,8) |
NS NS |
| Normal neurological examination before procedure** | 48 (100) | 51 (100) | NS |
Analytic study
The study of the durations of the procedure statistically comparable between groups 1 and 2. The analysis of the duration of anesthetic induction is longer in group 2 than in group 1 (12.1 ± 3.2 vs 7.1 ± 2.2, p=0.045). On the other hand, transhipment after complete awakening (Aldrette score at 12/12 or 11/12 in group 2) is faster in the spinal analgesia group (3.1 ± 2.2 vs 9.4 ± 5.8 p=0.038) During the performance of the anesthetic act, changes in the constants remained within the normal range after induction for 89 cases (89.9%), 95 cases (95.9%) intraoperatively and 98 cases (98.9%) on discharge from the patient; without there being any difference between the 2 groups. The technique use achieved its anesthetic goals in all cases (n=48) in group 1 and en 50 cases (98%) in group 2. The collection of adverse events related to anesthesia accounted for a total of 9 events (respectively 6 in group 1 and 3 in group 2) occurred en 6 patients: 3 cases arterial hypotension (1 vs 2); 1 case of desaturation with inhalation (1 vs 0), 4 cases of nausea and/or vomiting (3 vs 1).
Evaluation of analgesia during:
• the mobilization found in group 1, 40 cases (83.3%) with VAS <4 versus 51 cases (100%) in group 2 (p=0.055).
• arriving at the CT scan room, only 12 cases (25%) were found in group 1 versus 45 cases (88.2%) in group 2 (p=0.02).
All patients in group 1 (n=48) required additional analgesia (according to established protocols), wake-up mobilization and scanner room. In group 2 (n=51), only 1 patient on awakening (2%) and 15 patients on CT scan (29.5%) required an intravenous analgesic supplement (p <0.001). The results are shown in Table 4 (Table 2, 3 and 4).
| Caracteristics | Group 1 n = 48 |
Group 2 n = 51 |
P |
|---|---|---|---|
| Duration of the surgical procedure** | 12 [7; 35] | 14 [8; 28] | 0,65 |
| Duration of anesthetic induction * | 7,1 ± 2,2 | 12,1 ± 3,2 | 0,045 |
| Wake up time - transhipment * | 9,4 ± 5,8 | 3,1 ± 2,2 | 0,038 |
| Total duration of the procedure * | 47,4 ± 8,7 | 49,7 ± 8,4 | 0,46 |
| Variations (induction) > 20% *** Cardiac frequency Systolic arterial pressure Diastolic arterial pressure |
6 (12,5) 3 (6,25) 2 (4,1) |
4 (7,8) 4 (7,8) 2 (3,9) |
0,12 0,45 0,61 |
| Variations per op > 20% *** Cardiac frequency Systolic arterial pressure Diastolic arterial pressure |
2 (4,1) 6 (12,5) 2 (4,1) |
2 (3,9) 4 (7,8) 3 (2,6) |
0,25 0,38 0,74 |
| Variations at the exit > at 20% *** Cardiac frequency Systolic arterial pressure Diastolic arterial pressure |
0 (0) 0 (0) 0 (0) |
1 (1,9) 0 (0) 0 (0) |
0,78 0,87 0,9 |
| Success of the anesthetic technique *** | 48 (100) | 50 (98) | 0,78 |
| Caracteristics | Group 1 n = 48 |
Group 2 n = 51 |
P |
|---|---|---|---|
| Cardiovascular* Hypotension Rhythm disorders |
1 (2,1) 0 (0) |
2 (3,9) 0 (0) |
0,31 0,98 |
| Respiratory * desaturation Spasm Inhalation |
1 (2,1) 0 (0) 1 (2,1) |
0 (0) 0 (0) 0 (0) |
NS |
| Nausea per / post operative * | 1 (2,1) | 1 (1,9) | 0,24 |
| Vomiting per / postop * | 2 (4,1) | 0 (0) | 0,09 |
| Caracteristics | Group 1 n = 48 |
Group 2 n = 51 |
P |
|---|---|---|---|
| Bromage score at 0 Transhipment |
48 (100) | 51 (100) | NS |
| EVA at transhipment <4 EVA = 0 -1 EVA = 2 – 3 |
40 (83,3) 0 (0) 40 (100) |
51 (100) 50 (98) 1 (2) |
0,055 < 0,001 < 0,001 |
| EVA at the scanner <4 EVA = 0 -1 EVA = 2 – 3 |
12 (25) 0 (0) 12 (100) |
45 (88,2) 36 (80) 9 (20) |
0,02 < 0,001 < 0,01 |
Intra-cavitary radiotherapy has revolutionized the management of cervical cancer. It involves the insertion of an intrauterine vector (or applicator) through the vulva, the vagina, the cervix and positioned against the uterine fundus. In order to diffuse isotope radio at the level of diseased uterine tissues. This procedure requires positioning the patient in a lithotomy position (or gynecological position) and then exposing the intravaginal cavity. After measuring the depth of the uterus by a hysterometer, the diffèrent applicators (metal conduit) are introduced and fixed together. These different times require a relaxation of muscle and cooperation of the patient [4]. There are various anesthetic techniques that can be use for the placement of applicators. Each of these techniques has advantages and disadvantages [5]. In our context, sedation has been the standard technique used at the National Institute of Oncology since the beginning of its activity in 1984. The conditions of anesthesia and operating procedures improved 4 years ago with the construction of an operating room dedicated to Brachytherapy and equipped with a standard anesthesia station, allowing to perform all types of anesthetic acts in a safe way. As part of a process of diversification of anesthetic techniques used to have a technical alternative, we decided to conduct a feasibility study comparing the usual technique (sedation) to spinal analgesia. The results show that spinal analgesia is a technique for performing the act of setting up an applicator by Brachytherapy operator. Without hindering the duration of the act, its safety, or the comfort of the Brachytherapy operator.
98% of patients had their applicators placed without the need for additional intravenous anesthesia. In addition, the analgesia obtained during surgery achieved its objectives: VAS at 0 during the procedure, while maintaining a bromage score of 0. Similarly, the mobility of the patient did not hinder the gesture; this is perceptible by the fact that no technical complication has been reported. The operating times were not statistically different. In addition this allowed the patient to participate in its mobilization and its installation on the table and cart with better analgesia in comparison with the sedation group. The satisfaction of the paramedical staff has also been reported. Adverse effects related to anesthetic techniques studied in both groups, whether hemodynamic/ cardiovascular, respiratory, neurological, allergic or preoperative nausea and vomiting. Regarding the effects of anesthesia, in both techniques, no serious cardiovascular events were observed. The number of significant hemodynamic variations was small and the analysis of the two groups found no difference between intravenous anesthesia and spinal analgesia. Only one respiratory event occurred in the 'sedation' group, patient had vomiting with inhalation, causing desaturation. No neurological complications were noted. On the other hand we did not notice any serious allergic reaction. However 38 patients (74.5%) in group 2 had a minor cough with pruritus without skin reaction following spinal analgesia. These events were attributed to the use of intrathecal fentanyl. No patient received prevention for nausea/vomiting. 2 minor cases havent been reported. one of the major contributions of this work is related to the advantage of the locoregional technique in the prolongation of pelvic analgesia during mobilization on awakening of the patient and until transport to the radiology department for the realization (with a new transhipment) of a control imagerie (<20 minutes from the exit, from the operating room). Our results showed that spinal analgesia significantly relieved the pain of a large number of patients. In addition, this has made it possible to dispense with an intravenous analgesic of palliate 1 (paracetamol, NSAID or Nefopam) in addition to the exit of the operating room.
It is reported in the literature that the management of postoperative analgesia is common intravenously. The protocols used are based on those of postoperative pain in pelvic gynecological surgery [6]. In our context, we opted for spinal analgesia with opioid addiction in a future protocol to study the quality of management of pain postoperatively at a distance from the block procedure [7]. Conducted a retrospective study of 952 patients (860 women) and 1622 procedures. The majority of anesthetic procedures (n=1065-65%) were general anesthesia (vs 567 locoregional anesthesia-35%); no local anesthesia was used. This review concludes that although limited, locoregional anesthesia appears to be beneficial for the comfort, analgesia and safety of patients admitted to Brachytherapy service. No steroidients anti inflammatory and paracetamol and especially their association with codeine phosphate contributes to a multimodal management of pain. It responds in particular to the painful sensation like cramp. It is suggested that the use of NSAIDs will reduce the prescription of opioids for pain management [8].
This clinical work aimed to determine the feasibility of a routine locoregional anesthesia protocol as an alternative to sedation. This study made it possible to demonstrate its feasibility in a safe way with satisfactory results beyond our expectations regarding the effectiveness of analgesia per and post operative. However, there is a limit in the methodology of the work and It concerns the criterion of judgment. Indeed, we compared two different anesthetic techniques, which can not have the same objective comparison criterion. Only consistent clinical data (hemodynamic, respiratory, and adverse effects) were evaluated in both groups. This limit is insurmountable from a technical point of view, making the test necessarily an open quality.
Since this study, spinal analgesia with bupivacaine has become the standard technique in our practice, leaving propofol sedation as the alternative. Several protocols have been tried and raise the issue of the best prescription. However, there is a limit in the methodology of the work and it concerns the criterion of judgment. Indeed, we compared two different anesthetic techniques, which cannot have the same objective comparison criterion.
None.
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