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Intrathecal hyperbaric versus isobaric bupivacaine for adult non-caesarean-section surgery: systematic review protocol.

ABSTRACT: Bupivacaine is the most commonly used local anaesthetic for spinal anaesthesia (SA). There are two forms of commercially available bupivacaine; isobaric bupivacaine (IB): a formulation with a specific gravity or density equal to cerebrospinal fluid, and hyperbaric bupivacaine (HB): a formulation with density heavier than cerebrospinal fluid. The difference in densities of the two available preparations is believed to affect the diffusion pattern that determines the effectiveness, spread and side-effect profile of bupivacaine. This systematic review will summarise the best available evidence regarding the effectiveness and safety on the use of HB compared with IB, when used to provide SA for surgery. Primarily, we will analyse the need for conversion to general anaesthesia. As secondary outcomes, we will compare the incidence of hypotension, incidence of nausea/vomiting, the onset time and duration of anaesthesia.We will search key electronic databases using search strategy (1) injections, spinal OR intrathecal OR subarachnoid; (2) bupivacaine OR levobupivacaine; (3) hypobaric OR isobaric OR plain; (4) baricity. We will search MEDLINE, EMBASE and Cochrane databases, from their inception for randomised controlled trials, with no restrictions on language. Caesarean section surgery will be excluded. 2 reviewers will independently extract the data using a standardised form. Extracted items will include study characteristics, risk of bias domains, as per modified Cochrane risk of bias, participant disposition and study outcomes. We will conduct a meta-analysis for variables that can be compared across the studies. We will evaluate clinical heterogeneity by qualitatively appraising differences in study characteristics in participants, interventions and the outcomes assessed. We will report our findings as relative risks (dichotomous), and weighted mean differences (continuous) for individual outcomes, along with their 95% CIs.We plan to submit, and will publish, our findings in a peer-reviewed scientific journal, and present our results at national and international meetings.CRD42015017672.

SUBMITTER: Uppal V

PROVIDER: S-EPMC4874203 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Project description:Background and purposeAdding adjuvants to intrathecal hyperbaric bupivacaine provides long analgesic duration with less adverse effects. The aim of this study was to compare intrathecal nalbuphine versus midazolam in patients undergoing cesarean section.Clinical trial idNCT03918187.Patients and methodsThis was a prospective randomized controlled study conducted on 90 females undergoing cesarean section under spinal anesthesia who were randomly allocated to three equal groups of 30 patients each: group C received hyperbaric bupivacaine 12.5 mg plus 0.5 mL saline, group N received hyperbaric bupivacaine 12.5 mg plus 1 mg nalbuphine, group M received hyperbaric bupivacaine 12.5 mg plus 2.5 mg midazolam. The onset and duration of sensory and motor block, effective analgesic time, analgesic requirements, adverse effects, sedation, and Apgar scores were recorded.ResultsThere was significant rapid onset of sensory and motor block (1.95±.44 and 3.50±0.43 min) with slower regression of sensory block and time to bromage I (211.6±13.2 and 219.8±20.2 min) in group N compared to groups M, C (p < 0.001), with statistically significant rapid onset and long duration of both blocks in group M compared to C (p<0.001). The effective analgesic time was significantly prolonged in group N (263.7±16.3) compared to groups M and C (224.2 ± 18.6, 185.5±17.45), respectively, (p<0.001) and prolonged in group M compared to C (p<0.001), with increase in analgesic requirement in group C compared to groups N and M (p<0.001) and no significant difference between groups N and M. There was higher sedation score in groups N, M (1.78±0.63, 2.75±0.54), respectively, compared to group C (0.61±0.12) (p<0.001) with lower Apgar score in group M (6.9±0.73) at one minute than in groups N, C (7.1±0.91, 7.7±0.84) (p<0.001). There was no significant difference between groups regarding the adverse effects.ConclusionAdding 1 mg nalbuphine to 12.5 mg hyperbaric bupivacaine provided more effective postoperative analgesia than adding 2.5 mg midazolam, with less non-significant adverse effects in midazolam group in patients undergoing elective cesarean section.

Project description:Various advantages of isobaric bupivacaine, levobupivacaine, and hyperbaric bupivacaine are described. There are no studies reliably determining the benefits of these forms of bupivacaine. The purpose of the study was to compare the efficacy of spinal anesthesia (SA) performed with 0.5% isobaric bupivacaine, 0.5% levobupivacaine, and 0.5% hyperbaric bupivacaine. The clinical study was approved by the ethics committee. The sample size was calculated for a confidence level of 99%. 111 patients were randomly allocated into 3 equal groups for spinal anesthesia in lower limb surgeries. In group 1 (1B) spinal anesthesia was performed with 3 ml of 0.5% isobaric bupivacaine (n = 37); in group 2 (2L)-3 ml of 0.5% levobupivacaine (n = 37), in group 3 (3H)-3 ml of 0.5% hyperbaric bupivacaine (n = 37). The criterion for assessing the effectiveness of anesthesia was the need to switch to another type of anesthesia (criterion-no anesthesia), or the need for additional use of narcotic analgesics or local anesthesia during surgery (criterion-reporting of painful feelings during the operation). In 1B anesthesia efficiency by the criterion of additional intraoperative analgesia was 100% (37 patients; 95% CI [0.88-1.0]); 2L-86.4%; (31 patients; 95% CI [0.68-0.92]); 3H-72.9% (27 patients; 95% CI [0.56-0.84]). There were significant differences between groups 1B and 2L: p < 0.05 (p = 0.0104). There were no significant differences between groups 2L and 3H (p = 0.2587). All patients in group 1B developed complete sensory block (++) within 4 (3; 5) min. In group 2L complete sensory block developed in 34 patients (89.4%) within 9 (5; 14) min, in group 3H sensory block developed in all patients within 3 (2.5; 4). The duration of analgesia period between 1B and 2L did not statistically differ (p = 0.73). In 3H the duration of analgesia was 170 (150; 200) min. The study found 83.7% efficacy of levobupivacaine and 72.9% efficacy of hyperbaric bupivacaine in comparison with isobaric bupivacaine (100%) when administered intrathecally in equal volumes and amounts (by the criterion of additional intraoperative analgesia).Trial registration: NCT05184465 (Initial Release: 12/01/2021; date of first publication-11/01/2022).

Project description:BACKGROUND:Spinal anesthesia is a form of regional anesthesia frequently used in various lower abdominal, orthopedic, obstetric operations such as a cesarean delivery. The most common local anesthetic used for spinal anesthesia in obstetric and non-obstetric surgery is bupivacaine which can be utilized as an isobaric or hyperbaric solution, producing differences in maternal hemodynamic changes. Against this backdrop, the study aims to compare the effects of isobaric and hyperbaric bupivacaine on maternal hemodynamic alterations after administering spinal anesthesia for elective cesarean delivery at Gandhi Memorial Hospital, Addis Ababa, Ethiopia. METHODS:A hospital-based prospective cohort study design was employed for the period December 1, 2017 to January 30, 2018. A total of 100 parturient were involved, with one group exposed to isobaric bupivacaine and the other to hyperbaric bupivacaine to observe their effects on maternal hemodynamic changes post spinal anesthesia. The participants were selected through systematic random sampling. Data analysis was performed using SPSS (version 20) through descriptive statistic, independent sample t-test, Mann-Whitney U-test, Fisher's exact test, and Chi-square test were used. P values of <0.05 was assumed as statistically significant for all tests. RESULTS:The incidence of hypotension was found to be greater in isobaric than hyperbaric groups (82% vs. 60% respectively; p = 0.015). No statistical significant differences were found in mean arterial pressure value at baseline, but, statistically significant changes were observed among the groups (p <0.05) at all study timing after spinal anesthesia, except at 30thmin. No statistically significant differences were seen in the mean heart rate variability after spinal anesthesia at all periods, except the 15th minute (p = 0.033). A greater rate of vasopressor was used in the isobaric group as compared to the hyperbaric group (36% vs. 14% respectively; p = 0.011). CONCLUSION:Baricity is a significant factor in maternal hemodynamic changes in the parturient for elective cesarean section. Isobaric bupivacaine produces greater change in blood pressure and incidence of hypotension and entails a greater vasopressor requirement than hyperbaric bupivacaine after spinal anesthesia for elective cesarean section.

Project description:Background: Obesity, abdominal surgery, and intrathecal opioids are all factors associated with a risk for respiratory compromise. The aim of this explorative trial was to study the apnoea/hypopnea index 1st postoperative night in obese mothers having had caesarean section (CS) in spinal anaesthesia with a combination of bupivacaine/morphine and fentanyl. Methods: Consecutive obese (BMI >30 kg/m 2) mothers, ≥18 years, scheduled for CS with bupivacaine/morphine/fentanyl spinal anaesthesia were monitored with a portable polygraphy device Embletta /NOX on 1 st postoperative night. The apnoea/hypopnea index (AHI) was identified by clinical algorithm and assessed in accordance to general guidelines; number of apnoea/hypopnea episodes per hour: <5 "normal", ≥5 and <15 mild sleep apnoea, ≥15 and <30 moderate sleep apnoea, ≥ 30 severe sleep apnoea. Oxygen desaturation events were in similar manner calculated per hour as oxygen desaturation index (ODI). Results: Forty mothers were invited to participate: 27 consented, 23 were included, but polysomnography registration failed in 3. Among the 20 mothers studied: 11 had an AHI <5 ( normal), 7 mothers had AHI ≥5 but <15 ( mild OSAS) and 2 mothers had AHI ≥15 ( moderate OSA), none had an AHI ≥ 30. The ODI was on average 4.4, and eight patients had an ODI >5. Mothers with a high AHI (15.3 and 18.2) did not show high ODI. Mean saturation was 94% (91-96%), and four mothers had mean SpO 2 90-94%, none had a mean SpO2 <90%. Conclusion: Respiratory polygraphy 1 st night after caesarean section in spinal anaesthesia with morphine in moderately obese mothers showed AHIs that in sleep medicine terms are considered normal, mild and moderate. Obstructive events and episodes of desaturation were commonly not synchronised. Further studies looking at preoperative screening for sleep apnoea in obese mothers are warranted but early postop respiratory polygraphy recording is cumbersome and provided sparse important information.

Project description:Objective:In this study, we aim to investigate the effect of different doses of dexmedetomidine as an adjuvant to hyperbaric ropivacaine in spinal anesthesia for cesarean section. Methods:Seventy-five parturients with American Society of Anesthesiologists (ASA) I or II were anesthetized with intrathecal ropivacaine (12.5 mg) alone (R group) or in combination with dexmedetomidine 3 ?g (RD3 group) and 5 ?g (RD5 group) to undergo a cesarean section. The anesthetic parameters, postoperative analgesia, stress responses and neonates outcomes were monitored. Results:The onset time of sensory block to T10, T4, and peak level in the RD3 group and RD5 group were significantly shorter than those in the R group (p < 0.05). The time of the level of sensory block to descend two segments and to T10 in the RD3 group(57.28 ± 16.65 min, 3.87 ± 1.60 h) and RD5 group (71.92 ± 10.10 min, 3.99 ± 1.06 h) were longer than that in the R group (40.64 ± 12.06 min, 1.98 ± 1.01 h) (p < 0.05). The median time of motor blockade to both legs score 3 on the Bromage scale (B3B3) in the RD3 group and RD5 group was shorter than that in the R group (p < 0.001). The time of motor blockade recovery to both legs score 0 on the Bromage scale (B0B0) in the RD5 group (3.6 h) was longer than that in the R group (2 h) or RD3 group (2.2 h) (p < 0.001). Visceral traction response and abdominal muscle relaxation during the operation in the RD3 group and the RD5 group were better than that in the R group. The Visual Analogue Score (VAS) in the 12 h after the operation in the RD3 group (3.30 ± 1.17) and RD5 group (2.80 ± 0.87) was smaller than that in the R group (3.80 ± 1.47) (p < 0.05). The incidence of shivering in the RD3 group and RD5 group was significantly lower than that in the R group (p < 0.05). The postoperative concentrations of c-reactive protein (CRP), interleukin-6 (IL-6) and cortisol in the RD3 and RD5 groups were lower than that in the R group (p < 0.05). Conclusion:3 µg intrathecal dexmedetomidine as an adjuvant to ropivacaine improved intraoperative somato-visceral sensory block characteristics and postoperative analgesia, alleviated shivering in parturients, and did not prolong the time of motor block or produce any side effects, which makes this dose appropriate for cesarean delivery. Cinical Trial Registration:ChiCTR, identifier ChiCTR1800014454. Registered 15 January 2018, http://www.chictr.org.cn/edit.aspx?pid=24613&htm=4.

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

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Intrathecal hyperbaric versus isobaric bupivacaine for adult non-caesarean-section surgery: systematic review protocol.

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