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Comparison of intrathecal levobupivacaine combined with sufentanil, fentanyl, or placebo for elective caesarean section: a prospective, randomized, double-blind, controlled study.

ABSTRACT: The addition of opioids to local anesthetics contributes to the quality of spinal anesthesia and postoperative analgesia.In our prospective, randomized, double-blind, controlled study, our aim was to compare the effect of low-dose sufentanil plus levobupivacaine or a fentanyl plus levobupivacaine mixture on anesthesia quality, block characteristics, newborn and mother well-being, surgeon satisfaction, and duration of postoperative analgesia.Ninety-three patients were randomized into 3 groups (n = 31). Patients in Group C received 0.5% levobupivacaine (2.2 ± 0.2 mL), Group S received 2.5 µg sufentanil plus 0.5% levobupivacaine (2.2 ± 0.2 mL), and Group F received 10 µg fentanyl plus 0.5% levobupivacaine (2.2 ± 0.2 mL) intrathecally completed to a volume of 3 mL with the addition of saline in all groups. Patients' demographics, sensory and motor block characteristics, hemodynamics, Apgar scores, umbilical blood gas values, maternal side effects, surgeon satisfaction score, time to first analgesia requirement, and additional analgesic use within 24 hours were recorded.In Group S and Group F, target levels of sensory and motor block were achieved more rapidly (P < 0.001). The hemodynamic values were lower (P < 0.05), and the duration of sensory blockade and the time of first analgesic requirement were longer (P < 0.001) in Group S. Additional analgesic requirement during first 24-hour period was lowest in Group S, and highest in Group C (P < 0.001). Apgar scores and umbilical blood gas samples were similar between groups. Postoperative pruritus was more frequent in Group S (P < 0.001) and surgeon satisfaction score was significantly lower in Group C (P = 0.003).We suggest that the addition of sufentanil and fentanyl to intrathecal levobupivacaine during caesarean section surgery is more effective than the administration of levobupivacaine alone. The addition of sufentanil to levobupivacaine allowed rapid onset time for sensory and motor block levels. It also extended the duration of postoperative analgesia and led to a decrease in total analgesic requirement. ClinicalTrials.gov identifier: NCT01858090.

SUBMITTER: Bozdogan Ozyilkan N

PROVIDER: S-EPMC3898189 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Comparison of intrathecal levobupivacaine combined with sufentanil, fentanyl, or placebo for elective caesarean section: a prospective, randomized, double-blind, controlled study.

Bozdogan Ozyilkan Nesrin N Kocum Aysu A Sener Mesut M Caliskan Esra E Tarim Ebru E Ergenoglu Pinar P Aribogan Anis A

Current therapeutic research, clinical and experimental 20131201

<h4>Background</h4>The addition of opioids to local anesthetics contributes to the quality of spinal anesthesia and postoperative analgesia.<h4>Objective</h4>In our prospective, randomized, double-blind, controlled study, our aim was to compare the effect of low-dose sufentanil plus levobupivacaine or a fentanyl plus levobupivacaine mixture on anesthesia quality, block characteristics, newborn and mother well-being, surgeon satisfaction, and duration of postoperative analgesia.<h4>Methods</h4>Ni ...[more]

PMID: 24465046

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Project description: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.

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.

Project description:Caesarean section is associated with moderate-to-severe postoperative pain, which can influence postoperative recovery and patient satisfaction as well as breastfeeding success and mother-child bonding. The aim of this systematic review was to update the available literature and develop recommendations for optimal pain management after elective caesarean section under neuraxial anaesthesia. A systematic review utilising procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in the English language between 1 May 2014 and 22 October 2020 evaluating the effects of analgesic, anaesthetic and surgical interventions were retrieved from MEDLINE, Embase and Cochrane databases. Studies evaluating pain management for emergency or unplanned operative deliveries or caesarean section performed under general anaesthesia were excluded. A total of 145 studies met the inclusion criteria. For patients undergoing elective caesarean section performed under neuraxial anaesthesia, recommendations include intrathecal morphine 50-100 µg or diamorphine 300 µg administered pre-operatively; paracetamol; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone administered after delivery. If intrathecal opioid was not administered, single-injection local anaesthetic wound infiltration; continuous wound local anaesthetic infusion; and/or fascial plane blocks such as transversus abdominis plane or quadratus lumborum blocks are recommended. The postoperative regimen should include regular paracetamol and non-steroidal anti-inflammatory drugs with opioids used for rescue. The surgical technique should include a Joel-Cohen incision; non-closure of the peritoneum; and abdominal binders. Transcutaneous electrical nerve stimulation could be used as analgesic adjunct. Some of the interventions, although effective, carry risks, and consequentially were omitted from the recommendations. Some interventions were not recommended due to insufficient, inconsistent or lack of evidence. Of note, these recommendations may not be applicable to unplanned deliveries or caesarean section performed under general anaesthesia.

Project description:BackgroundControlling massive haemorrhage from morbidly adherent placenta (MAP) at caesarean section is a major surgical challenge to obstetricians. This study compares different intra-operative interventions to control haemorrhage from morbidly adherent placenta and its impact on maternal morbidity.MethodsRetrospective analysis was done for baseline characteristics, intra-operative and postoperative complications of 125 patients with morbidly adherent placenta who had elective CS at 35-38 weeks gestation in the period from 01/2012 to 01/2017. The included patients were categorized into three groups according to intra-operative interventions they had for controlling bleeding; Group A (n = 42) had only balloon tamponade, Group B (n = 40) had balloon tamponade and bilateral uterine artery ligation, in Group C (n = 43) all cases were managed by bilateral uterine artery ligation and inverting the cervix into the uterine cavity and suturing the anterior and/or the posterior cervical lips into the anterior and/or posterior walls of the lower uterine segment using the cervix as a natural tamponade.ResultsThere were no differences of baseline characteristics of patients in all groups. Group C had significantly better outcomes as compared with groups A and B; less total blood loss (Group C 2869.5 ml vs Group B 4580 ml, Group A 4812 ml, P < 0.001), less requirement of blood transfusion more than 4 units (Group C 4/43, Group B 10/40,Group A 12/42, P < 0.02), significant reduction in prolonged hospital stay over 10 days (Group C 2/43, Group B 9/40,Group A 14/42, P < 0.001) and lower risk of coagulopathy (Group C 4/43, B 8/40, A 9/42), visceral injuries (Group C 4/43 vs B 8/40, A 10/42,P < 0.01) and need for hysterectomy (Group C 4/43 vs B 11/40, A 13/42,P < 0.001).ConclusionA combination bilateral uterine artery ligation and using the cervix as a natural tamponade are very effective and simple methods in controlling bleeding resulting from separated placenta accreta.Trial registrationThe findings are part of the research project registered in ClinicalTrials.gov NCT02590484 . Registered 28 October 2015.

Project description:BackgroundThe study aimed to investigate whether prophylactic use of glycopyrrolate decreases the vasopressor requirements to prevent hypotension following spinal anesthesia during non-elective cesarean section.MethodIn this double-blind randomized clinical trial, 258 patients undergoing non-elective cesarean section were randomly assigned (1:1) to receive intravenous 0.2 mg glycopyrrolate or normal saline (placebo) before spinal anesthesia. The primary outcome was phenylephrine equivalent needed intraoperatively. Secondary outcomes included incidences of maternal hypotension, reactive hypertension, bradycardia, need for atropine, tachycardia, intraoperative nausea/vomiting, shivering, pruritus, dry mouth, dizziness; neonatal APGAR score at 1 min and 5 min, neonatal resuscitation needed, NICU admission and neonatal death.ResultsThree patients withdrew from the study due to failed spinal anesthesia. 128 patients in the glycopyrrolate group and 127 patients in the placebo group were analyzed. The mean phenylephrine equivalent needed was 1108.96 μg in the glycopyrrolate group and 1103.64 μg in the placebo group (mean difference, 5.32 μg [95% CI - 67.97 to 78.62]; P = 0.88). Hypotension occurred in 38 patients (30%) in the glycopyrrolate group as compared with 49 patients (39%) in the placebo group (P = 0.13). Tachycardia was reported in 70% of the participants in the glycopyrrolate group and 57% of those in the placebo group (P = 0.04). No statistically significant difference was noted in hypotensive episodes > 1, reactive hypertension, bradycardia, need for atropine, nausea, vomiting, shivering, and dry mouth between the two groups. Neonatal outcomes were similar in the two groups.ConclusionProphylactic use of glycopyrrolate does not decrease the requirements of vasopressor to prevent hypotension in non-elective cesarean section under spinal anesthesia.Trial registrationRegistration number: NCT04401345. Date of registration: 26/05/2020. Website: https://clinicaltrials.gov.

Dataset Information

Comparison of intrathecal levobupivacaine combined with sufentanil, fentanyl, or placebo for elective caesarean section: a prospective, randomized, double-blind, controlled study.

Publications

Comparison of intrathecal levobupivacaine combined with sufentanil, fentanyl, or placebo for elective caesarean section: a prospective, randomized, double-blind, controlled study.

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