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1,702 result(s) for "Analgesia, Obstetrical"
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Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial
About a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental vaginal delivery. Remifentanil patient-controlled analgesia (PCA) in labour is an alternative to pethidine, but is not widely used. We aimed to evaluate epidural analgesia progression among women using remifentanil PCA compared with pethidine. We did an open-label, multicentre, randomised controlled trial in 14 UK maternity units. We included women aged 16 years or older, beyond 37 weeks' gestation, in labour with a singleton cephalic presentation, and who requested opioid pain relief. We randomly assigned eligible participants (1:1) to either the intravenous remifentanil PCA group (40 μg bolus on demand with a 2 min lockout) or the intramuscular pethidine group (100 mg every 4 h, up to 400 mg in 24 h), using a web-based or telephone randomisation service with a minimisation algorithm for parity, maternal age, ethnicity, and mode of labour onset. Because of the differences in routes of drug administration, study participants and health-care providers were not masked to the group allocation. The primary outcome was the proportion of women who received epidural analgesia after enrolment for pain relief in labour. Primary analyses were unadjusted and analysed by the intention-to-treat principle. This study is registered with the ISRCTN registry, number ISRCTN29654603. Between May 13, 2014, and Sept 2, 2016, 201 women were randomly assigned to the remifentanil PCA group and 200 to the pethidine group. One participant in the pethidine group withdrew consent, leaving 199 for analyses. The proportions of epidural conversion were 19% (39 of 201) in the remifentanil PCA group and 41% (81 of 199) in the pethidine group (risk ratio 0·48, 95% CI 0·34–0·66; p<0·0001). There were no serious adverse events or drug reactions directly attributable to either analgesic during the study. Intravenous remifentanil PCA halved the proportion of epidural conversions compared with intramuscular pethidine. This finding challenges routine pethidine use as standard of care in labour. National Institute for Health Research Clinician Scientist Award.
Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial
BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However, few studies have investigated whether this technique confers advantages during the maintenance of analgesia. This randomized double-blinded controlled study compared dural puncture epidural analgesia with standard epidural analgesia when analgesia was maintained using programmed intermittent epidural boluses.Methods400 parturients requesting epidural labor analgesia were randomized to have analgesia initiated with a test dose of 3 mL lidocaine 1.5% with epinephrine 15 µg, followed by 12 mL ropivacaine 0.15% mixed with sufentanil 0.5 µg/mL using the dural puncture epidural or the standard epidural technique. After confirming satisfactory analgesia, analgesia was maintained with ropivacaine 0.1% and sufentanil 0.5 µg/mL via programmed intermittent epidural boluses (fixed volume 8 mL, intervals 40 min). We compared local anesthetic consumption, pain scores, obstetric and neonatal outcomes and patient satisfaction.ResultsA total of 339 patients completed the study and had data analyzed. There were no differences between the dural puncture epidural and standard epidural groups in ropivacaine consumption (mean difference −0.724 mg, 95% CI of difference −1.450 to 0.001 mg, p=0.051), pain scores, time to first programmed intermittent epidural bolus, the number of programmed intermittent epidural boluses, the number of manual epidural boluses, obstetric outcome or neonatal outcome. Patient satisfaction scores were statistically higher in the dural puncture epidural group but the absolute difference in scores was small.ConclusionOur findings suggest that when labor analgesia is maintained using the programmed intermittent epidural bolus method, there is no significant advantage to initiating analgesia using the dural puncture epidural compared with the standard epidural technique.Trial registration numberChiCTR2200062349.
Posterior quadratus lumborum block versus intrathecal morphine analgesia after scheduled cesarean section: a prospective, randomized, controlled study
BackgroundDuring the postoperative period of elective cesarean section, intrathecal morphine is effective in the multimodal analgesic regimen, but can cause significant adverse effects. Bilateral posterior quadratus lumborum block could be alternatively used. The aim of this study was to compare efficacy and safety of both strategies as part of a multimodal analgesic regimen.MethodsThis was a prospective, randomized, blinded, controlled study. 104 parturients were randomly selected to receive intrathecal morphine or posterior quadratus lumborum block during cesarean section under spinal anesthesia. The primary endpoint was patient-controlled 24-hour cumulative intravenous morphine use. Secondary endpoints were 48-hour cumulative morphine use, static/dynamic pain scores, functional recovery (ObsQoR-11 questionnaire) and adverse effects.ResultsThere was no statistical difference in the mean cumulative morphine dose at 24-hour between groups (posterior quadratus lumborum block group, 13.7 (97.5% CI 10.4 to 16.9) mg; intrathecal morphine group, 11.1 (97.5% CI 8.4 to 13.8) mg, p=0.111). Pain scores did not show any difference between groups, excepted at 6 hours for the pain at cough/movement in favor of the posterior quadratus lumborum block group (p=0.013). A better recovery quality was observed at 24 hours in the posterior quadratus lumborum block group (p=0.009). Pruritus was more frequent in intrathecal morphine group parturients (35% vs 2%)ConclusionsNo difference in cumulative morphine dose at 24 hours was observed in posterior quadratus lumborum block group compared with intrathecal morphine group. Posterior quadratus lumborum block can be considered an alternative to intrathecal morphine in cesarean postoperative analgesia, especially in cases of intolerance to morphine.Trial registration numberNCT04755712.
Pocket warming of bupivacaine with fentanyl to shorten onset of labor epidural analgesia: A double-blind randomized controlled clinical trial
Shortening analgesic onset has been researched and it has been documented that prewarming epidural medications to body temperature (37°C) prior to administration increases medication efficacy. Our double-blind randomized controlled trial was designed to investigate if a lower degree of prewarming in providers’ pockets could achieve similar results without the need of a bedside incubator. A total of 136 parturients were randomized into either the pocket-warmed group or the room temperature group to receive 10 mL of 0.125% bupivacaine with 2 μg/mL fentanyl epidural bolus at either the 27.8 ±1.7°C or 22.1 ±1.0°C temperatures, respectively. Primary outcome, time to analgesic onset (verbal rating scale pain score ≤ 3) was recorded in 0-, 5-, 10-, 15-, 20-, 30-, and 60-minutes intervals. It was observed that the pocket-warming group (n = 64) and room temperature group (n = 72) had no significant difference of analgesic onset time (median 8 vs. 6.2 minutes; p = 0.322). The incidence of adverse events such as hypotension, fever (≥ 38°C), nausea, vomiting, and number of top-off epidural boluses, as well as patient satisfaction rates and mode of delivery, were not significantly different between the groups as well. Further research is warranted to confirm these findings and explore the impact of different temperatures on analgesic onset time as well as the logistical issues associated with their clinical implementations.
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia between dural puncture epidural and combined spinal epidural technique: a pilot study
Background Abnormal cardiotocogram (CTG) tracing may appear after induction of neuraxial labor analgesia. Non-reassuring fetal status (NRFS) indicated by severely abnormal tracings, such as prolonged deceleration (PD) or bradycardia, can necessitate immediate operative delivery. Combined spinal epidural analgesia (CSEA) is known to result in more frequent abnormal tracings than epidural analgesia (EA); however, the corresponding data related to dural puncture epidural (DPE) are unclear. We aimed to evaluate the rates of incidence of severe abnormal CTG after induction of DPE and CSEA. Methods In this study of nulliparous women with full-term pregnancy, data for the DPE intervention group were prospectively collected, while those for the CSEA control group were obtained from medical records. Neuraxial analgesia was performed with cervical dilation ≤ 5 cm, administering initial epidural dosing of 15 mL of 0.125% levobupivacaine with fentanyl 2.5µg/mL for DPE, and intrathecal 0.5% bupivacaine 2.5 mg (0.5ml), fentanyl 10 µg (0.2ml), and 1.3 mL of saline for CSEA. The primary outcome was the incidence of PD, defined as a fetal heart rate reduction ≥ 15 bpm below the baseline and with a lowest value < 80 bpm, and lasting for ≥ 2 min but < 10 min (fetal heart rate < 80 bpm does not have to last for ≥ 2 min), within 90 min after induction of neuraxial labor analgesia. Results A total of 302 patients were analyzed, with 151 in each group. The incidence of PD after DPE induction was significantly lower than that after CSEA induction (4.0% vs. 14.6%, P  = 0.0015, odds ratio = 0.243, 95% confidence interval = 0.095–0.617). Conclusion DPE appears to be a safer method compared to CSEA for neuraxial labor analgesia in the early stages of labor for nulliparous women. Trial registration UMIN-CTR: UMIN000035153 . Date registered: 01/01/2019.
Dural puncture epidural technique with 23-, 25- or 27-gauge pencil point spinal needles versus standard epidural technique for labor analgesia: a randomized trial
Background Dural puncture epidural (DPE) improves labor analgesia by reducing numeric rating scale (NRS) score, accelerating onset, and enhancing sacral blockade. Although larger-gauge needles may potentiate local anesthetic diffusion and improve analgesic quality, current clinical practice favors smaller-gauge needles (25-gauge to 27-gauge) to mitigate post-dural puncture headache (PDPH) risks. This randomized trial specifically evaluates the differential impacts of 23-gauge, 25-gauge, and 27-gauge needles on both analgesic efficacy and procedure-related complications. Methods In this randomized trial, 200 parturients requesting labor analgesia received DPE (23-gauge, 25-gauge, 27-gauge subgroups) or standard epidural (EP), followed by programmed intermittent epidural boluses (PIEB) of 12 mL with ropivacaine 0.08% and sufentanil 0.33 µg/mL every 50 min. Primary outcome was NRS score 10 min after the initial epidural bolus; secondary outcomes included time to NRS score ≤ 1, block characteristics at 20 min, number of top-up boluses, Apgar scores, and adverse events. Results Among 198 analyzed participants, all DPE groups exhibited lower 10-minute NRS scores versus EP groups ( P  < 0.001). The 23-gauge and 25-gauge subgroups had lower NRS scores than 27-gauge ( P  < 0.05), with no difference between 23-gauge and 25-gauge ( P  > 0.05). The 23-gauge group achieved NRS score ≤ 1 fastest ( P  < 0.001). DPE groups demonstrated higher bilateral sacral (S2) blockade rates versus EP groups ( P  < 0.001), with no inter-subgroup differences. No significant difference were observed in procedure duration, top-up requirements, catheter adjustments/replacement, complications (PDPH, hypotension, nausea), or neonatal Apgar scores at 1 and 5 min. Conclusion Compared to conventional epidural analgesia, the combined application of DPE and PIEB techniques demonstrated superior quality. The utilization of 25-gauge pencil-point spinal needles achieves the optimal balance between analgesic efficacy and safety, while the 23-gauge needle may be suitable for specific scenarios requiring rapid onset of action.
The association of pain and psychological vulnerabilities with postpartum pain catastrophizing: a secondary analysis of a randomized controlled trial
Pain catastrophizing is an amplified negative thought process that emerges during actual or perceived pain moments. There is limited information on the role of labour pain in the development of pain catastrophizing during the postpartum period. We sought to investigate whether labour pain, pain, and psychological vulnerabilities are associated with high pain catastrophizing (defined as a Pain Catastrophizing Scale [PCS] ≥ 25) at 6-10 weeks postpartum. We conducted a secondary analysis of a randomized controlled trial that recruited pregnant individuals at term prior to labour and delivery. Participants filled in the predelivery questionnaires on labour pain, pain, and psychological vulnerabilities upon written consent. The recruited parturients also completed an online survey 6-10 weeks postpartum to determine the status of pain catastrophizing. Among the 820 parturients who completed the postpartum online survey, 116 (14.4%) were high pain catastrophizing. Multivariate logistic regression analysis found that greater enormity of labour pain (adjusted odds ratio [aOR], 1.04; 95% confidence interval [CI], 1.02 to 1.06), choosing nonepidural over epidural analgesia (aOR, 1.84; 95% CI, 1.17 to 2.91), having a family history of other mental disorders (aOR, 31.3; 95% CI, 5.7 to 173.7), greater predelivery pain catastrophizing (aOR, 2.70; 95% CI, 1.68 to 4.36), greater predelivery activity avoidance (aOR, 1.06; 95% CI, 1.04 to 1.09), and greater predelivery state anxiety (aOR, 1.03; 95% CI, 1.01 to 1.05) were associated with postpartum pain catastrophizing at 6-10 weeks postpartum. Having greater infant weight was protective against the risk of postpartum pain catastrophizing (aOR, 0.43; 95% CI, 0.23 to 0.78). The area under the curve of the generated multivariable model was 0.82 (95% CI, 0.78 to 0.86). Predelivery pain and psychological vulnerabilities were associated with postpartum pain catastrophizing among healthy parturients undergoing labour. Future prospective studies are needed to evaluate whether such risk factors can allow earlier intervention to reduce pain catastrophizing. ClinicalTrials.gov ( NCT03167905 ); first submitted 30 May 2017.
Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial
Background Up to 80% of women use some form of pharmacological analgesia during labour and birth. The side effects of pharmacological agents are often incompatible with the concurrent use of non-pharmacological pain relieving strategies, such as water immersion, ambulation and upright positioning, or may have negative effects on both the mother and fetus. Sterile water injections given into the skin of the lumbar region have been demonstrated to reduce back pain during labour. However, the injections given for back pain have no effect on abdominal contraction pain. The analgesic efficacy of sterile water injections for abdominal pain during childbirth is unknown. The injections cause an immediate, brief but significant pain that deters some women from using the procedure. This study aims to investigate the use of water injections given intradermally into the abdomen to relieve labour contraction pain. A vapocoolant spray will be applied to the skin immediately prior to the injections to reduce the injection pain. Methods In this pragmatic, placebo controlled trial 154 low-risk women in labour at term with a labour pain score ≥ 60 on a 100 millimitre visual analogue scale (VAS) will be randomly allocated to receive either six injections of sterile water or a sodium chloride 0.9% solution as a placebo (0.1–.0.3 ml per injection). Three injections are given along the midline from the fundus to the supra-pubis and three laterally across the supra-pubis. The primary outcome will be the difference in VAS score 30 min post injection between groups. Secondary outcomes include VAS score of the injection pain on administration, VAS score of labour pain at 60 and 90 min, maternal and neonatal birth outcomes. Discussion Access to effective pain relief during labour is fundamental to respectful and safe maternity care. Pharmacological analgesics should support rather than limit other non-pharmacological strategies. Sterile water injections have the potential to provide an alternative form of labour pain relief that is easy to administer in any labour and birth setting, and compatible with other non-pharmacological choices. Trial registration ANZCTR (ACTRN12621001036808) Date submitted: 22/06/2021. Date registered: 05/08/2021. https://www.anzctr.org.au/
Effect of programmed intermittent epidural boluses and continuous epidural infusion on labor analgesia and obstetric outcomes: a randomized controlled trial
PurposeContinuous epidural infusion and programmed intermittent epidural boluses are analgesic techniques routinely used for pain relief in laboring women. We aimed to assess both techniques and compare them with respect to labor analgesia and obstetric outcomes.MethodsAfter Institutional Review Board approval, 132 laboring women aged between 18 and 45 years were randomized to epidural analgesia of 10 mL of a mixture of 0.1% bupivacaine plus 2 µg/mL of fentanyl either by programmed intermittent boluses or continuous infusion (66 per group). Primary outcome was quality of analgesia. Secondary outcomes were duration of labor, total drug dose used, maternal satisfaction, sensory level, motor block level, presence of unilateral motor block, hemodynamics, side effects, mode of delivery, and newborn outcome.ResultsPatients in the programmed intermittent epidural boluses group received statistically less drug dose than those with continuous epidural infusion (24.9 vs 34.4 mL bupivacaine; P = 0.01). There was no difference between groups regarding pain control, characteristics of block, hemodynamics, side effects, and Apgar scores.ConclusionsOur study evidenced a lower anesthetic consumption in the programmed intermittent boluses group with similar labor analgesic control, and obstetric and newborn outcomes in both groups.
Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial
Background External Cephalic Version (ECV) is an effective procedure for modifying fetal position to achieve a cephalic presentation. ECV is usually performed with tocolysis and spinal anesthesia. Recently, propofol has been proposed as a sedative agent for ECV, showing promising results in observational studies. This clinical trial aims to compare the outcomes of ECV performed under tocolysis with either propofol or spinal anesthesia. Methods The PropoSpinECV randomized clinical trial is designed as a single-center, randomized, open-label trial. Participation will be offered to every pregnant woman with a non-cephalic presentation undergoing external cephalic version. Sedation with propofol and spinal analgesia with bupivacaine and fentanyl will be compared for ECV with a 1:1 allocation ratio. All procedures will be performed under tocolysis with ritodrine. The breech progression angle before ECV will be measured for all participants. The main outcome will be the ECV success rate. ECV complication rates and post-procedure pain will also be evaluated. Discussion The PropoSpinECV trial will thoroughly evaluate the efficacy of propofol in ECV. Additionally, this trial will investigate the role of the breech progression angle prior to ECV as a predictive variable for the success of the procedure. Trial registration The PropoSpinECV clinical trial is registered in the European Union Clinical Trial Database (EU CT number: 2024-510701-29-00) and in the ClinicalTrials.gov Database (NCT06449430) with the Clinical Trial Registry (2024-06-03).