scholarly journals Tramadol versus placebo for labor analgesia in low risk women: a randomized controlled trial

Author(s):  
Aastha Raheja ◽  
Krishna Agarwal ◽  
Rini Pachori ◽  
Gauri Gandhi

Background: In low- and middle-income countries epidural analgesia is generally not available and practically no form of labor analgesia is given to the majority of the parturient. The purpose of study was to evaluate the safety and efficacy of tramadol as a labor analgesic during first stage of labor.Methods: Pregnant women admitted in the labor room satisfying the eligibility criteria were randomized to receive intramuscular injection of either 100 mg tramadol or 2 ml distilled water. Visual analogue score (VAS) was assessed at the beginning and every hour till 4 hours. Pain satisfaction, duration of second stage of labor, fetal heart rate, mode of delivery, and any maternal side effects of the study drug were recorded. Neonatal evaluation using Apgar score at 1 and 5 minutes was done. For statistical analysis Student t-test, Chi Square test and Fisher’s exact test were used.Results: Total of 86 women were included in the study. The VAS scores were significantly lower in the tramadol group at 1, 2 and 3 hours after the administration. Pain relief satisfaction was significantly higher in the tramadol group. Rate of cervical dilatation, duration of the second and the third stage, need for instrumental delivery or lower segment caesarean section, rate of fetal distress and Apgar score at one and five minutes were comparable in both the groups. Nausea was significantly higher in tramadol group.Conclusions: Tramadol is a safe and efficacious drug which is inexpensive, easily available and easy to administer with few minor side effects. It can be used as a labour analgesic as an alternative to epidural analgesia in settings where epidural analgesia is not available. Trial registration: Clinicaltrials.gov PRS registration number: NCT02999594. 

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Ashok Jadon ◽  
Surabhi Srivastawa ◽  
Neelam Sinha ◽  
Swastika Chakraborty ◽  
Apoorva Bakshi ◽  
...  

Abstract Background The dural puncture epidural (DPE) technique is relatively a new technique of labor analgesia and has been advocated with the advantage of faster onset of pain relief. However, there are differences of opinion regarding the efficacy of the DPE technique and the size of the spinal needle to be used for the DPE. Various studies have suggested that DPE can only be done with a larger gauge of a spinal needle; however, recent studies have variable observations. We have compared the conventional lumbar epidural analgesia and DPE using a 27G pencil-point needle to assess the efficacy of DPE and its possible side effects. Results The time to achieve a 50% reduction in VAS was 7.06 ± 0.79 min in group CLE (n = 15) and 5.0 ± 1.06 min in group DPE (n = 15) (difference of two means was 2.06, 95% CI [1.36, 2.75], t = 5.99, p < 0.0001). The time to achieve VAS < 3 in group CLE was 14.93 ± 1.98 min, and in the group DPE, it was 10.13 ± 1.45 min (difference of two means was 4.8, 95% CI [3.52, 6.09], t = 7.55, p < 0.0001). The mode of delivery, APGAR scores, and side effects were comparable (p > 0.05). Conclusions DPE provided faster relief of labor pain than the conventional labor epidural analgesia. There were no added side effects by DPE in conventional lumbar epidural analgesia for labor. A 27G Whitacre pencil-point needle can be used for DPE. Trial registration CTRI, CTRI/2020/08/027060. Registered on 10/08/2020. Trial registered prospectively. CTRI website URL: http://ctri.nic.in


2002 ◽  
Vol 96 (5) ◽  
pp. 1070-1073 ◽  
Author(s):  
Kenneth E. Nelson ◽  
Traci Rauch ◽  
Victor Terebuh ◽  
Robert D'Angelo

Background The use of intrathecal opioids for labor analgesia continues to gain popularity, but there are limited data to guide this use. Previously, the authors established the ED50 for 60 min of labor analgesia from intrathecal sufentanil using an up-down sequential allocation study design. The current study first establishes an ED50 for intrathecal fentanyl using this same study design to establish an intrathecal potency ratio for fentanyl and sufentanil and then uses this ratio to compare the efficacy, duration of analgesia, and side effects from comparable doses of intrathecal fentanyl and sufentanil. Methods Seventy-five healthy nulliparous women requesting labor analgesia were enrolled in this two-part study. In phase I, 20 women received varying doses of fentanyl to establish an ED50 for 60 min of labor analgesia. In phase II, 55 women were randomized to receive either 36 microg intrathecal fentanyl or 8 microg sufentanil (2 times the ED50s) via a combined spinal-epidural technique and by double-blinded design. Pain relief, side effects, block height, maternal hemodynamics, and fetal heart rate were assessed throughout the study. The duration of spinal analgesia was considered to be the time from injection of study drug to the time of the patient's first request for additional analgesia. Results The ED50 of intrathecal fentanyl for 60 min of labor analgesia was found to be 18.2 microg, and therefore, the potency ratio of intrathecal sufentanil to intrathecal fentanyl at the ED50 level is 4.4:1. The duration of spinal analgesia was significantly longer from 8 microg intrathecal sufentanil than from 36 microg intrathecal fentanyl (104 +/- 34 vs. 79 +/- 34 min, P = 0.009). Otherwise, patient demographics, maternal hemodynamics, duration of labor, mode of delivery, motor block, subjective leg weakness, pruritus, nausea, pinprick sensory levels, visual analog scale pain scores, fetal bradycardia, and Apgar scores were similar between groups. Conclusion The relative potency of intrathecal sufentanil to fentanyl for labor analgesia is 4.4:1. When using intrathecal opioids alone for early labor analgesia, 8 microg sufentanil produces labor analgesia lasting approximately 25 min longer than from 36 microg fentanyl, without a statistically significant increase in side effects. However, when making a choice between fentanyl and sufentanil, one must consider other important factors, such as the higher cost of sufentanil and the greater risk of dosing error due to the higher potency of sufentanil compared with fentanyl.


1997 ◽  
Vol 86 (3) ◽  
pp. 592-598 ◽  
Author(s):  
Fazeela Ferouz ◽  
Mark C. Norris ◽  
Valerie A. Arkoosh ◽  
Barbara L. Leighton ◽  
Louis M. Boxer ◽  
...  

Background Intrathecal sufentanil relieves labor pain but centrally mediated side effects are common. Preventing rostral spread of intrathecal sufentanil should limit these side effects. Both direction of the lateral opening of a pencil-point needle and drug baricity modify the spread of intrathecal local anesthetics. This randomized, prospective, double-blind study examines the effects of these variables on intrathecal sufentanil labor analgesia. Methods Forty laboring, full-term parturients, whose cervixes were dilated less than 5 cm and who requested analgesia for labor were enrolled. Combined spinal epidural analgesia was induced in patients in the sitting position. They were allocated to receive 10 micrograms intrathecal sufentanil diluted with either normal saline or dextrose with the aperture of the pencil-point needle directed cephalad or caudad during drug injection. Thus there were four groups of ten patients: dextrose up, dextrose down, saline up, and saline down. Sufentanil was diluted with normal saline to a concentration of 10 micrograms/ml. The study drug was made by mixing 1 ml sufentanil solution with either 1 ml 10% dextrose or 1 ml normal saline. Visual analog scores for pain, pruritus, nausea, and pain relief were recorded before and 5, 10, 15, and 30 min after drug injection. Results Baricity, but not needle orientation, influenced pain relief and pruritus. Sufentanil in dextrose produced less itching but also less analgesia. Nine of 20 women in the dextrose groups compared with 1 of 20 in the saline groups requested additional analgesia by 30 min. Conclusions Little or no labor analgesia developed for patients receiving sufentanil with dextrose. A supraspinal action may contribute to intrathecal sufentanil's analgesic efficacy.


2017 ◽  
Vol 24 (02) ◽  
pp. 288-292
Author(s):  
Raheela Baloch ◽  
Nigar Jabeen ◽  
Sana Zahiruddin ◽  
Ms. Kiran Mawani

Efficacy and safety of intra-vaginal prostaglandin E2 pessary for induction ofLabor. Objectives: To evaluate the efficacy and safety of intra-vaginal prostaglandin E2 pessaryfor induction of Labor. Study Design: Case control study. Setting: Gynecological and obstetricward of Liaquat University of Medical and Health Sciences Hospital, Hyderabad. Period: 14 Feb2012 to 13 Feb 2013. Study Population: All the Pregnant women at term or post term admittedin gynae ward from 14th February 2012 to 13th February 2013. Results: 100 women recruitedin the study, study carried out at Gynecological ward of Liaquat University of Medical and HealthSciences Hospital Hyderabad. Analysis of booking status listed in Table-I revealed that 68% (n= 68) were un-booked having no antenatal care and 32.0% (n = 32) were booked. There wereno protocol violation, relation to the parity listed in Table-II showed maximum number of patients(n = 62) 62.0% Primigravida and (n = 38) 38.0% multigravidas were include. Age distributionis listed in Table-III maximum patients (n = 49) 49.0% at age between 26 - 35 years, 35 (35.0%)were between 20 - 25 years, 10 (10.0%) were >35 years and 06 (6.0%) patients were belong toless than 20 years. Regarding the gestational age 57 (57.0%) patients in our study presentedbetween 37 - 39 weeks of gestation. However, 47 (47.0%) patients were at 40 - >40 weeksof gestation showed in the (Table-IV). Indication for cervical ripening and induction of laboris listed on Table-V commonest indication was pregnancy induced hypertension followed byprolonged pregnancy, and IUGR etc. Table-VI shows the Bishop score 30 (30.0%) had BishopScore 2 – 3, while 70(70.00%) had a bishop score 4-5. Table-VII shows induction-deliveryinterval, Greater number of women (66/100) delivered within 24 hours of start of induction.Table-VIII showed mode of delivery, majority of the women had normal vaginal deliveries 64.00while 16 deliveries by assisted vaginal deliveries while in remaining 20 cases caesarean sectiondone. Table-IX shows four babies had an Apgar score 4/10 at end of 1 min and 7/10 at end of5 min, whereas 96 babies had an Apgar score of 9/10 in 1 min. The indications for caesareansection are shown in Table-X. There were 09(9%) cases of failed induction, 11 cases of a fetaldistress (Meconium stained liquor). There was no increased incidence of neonatal sepsis orChorioamniotis or puerperal sepsis in any of our patients. No perinatal morbidity or mortalityor any severe maternal complications were noted while mild side effects were noted which ismentioned in (Table-XI). Conclusion: In developed countries prostaglandin E2 are widely usedfor ripening of unfavorable cervix in induction of labor but patient response vomiting, diarrhea,tachycardia, and fever are commonly observed minor side effects. Induction with Prostaglandinreduced the rate of pregnancies progressing beyond 41 weeks and related feto-maternalmorbidity and mortality. After excluding contra indication all women should be offered inductionat 41 completed weeks. Induction with prostaglandin with medical disorder like preeclampsia issafe and better feto maternal outcome.


PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 99-108
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Еmilija Ivanov ◽  
Аtanas Sivevski ◽  
Ivo Kjaev ◽  
...  

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.


Author(s):  
Vasudha Sawant ◽  
Archana Kumbhar

Background: Experiencing labour pains and giving birth to infant is normal physiological process. Though it is a natural phenomenon, it produces severe pain which requires analgesia to relieve pain during labour. The objective of this study was to compare effects of low dose epidural analgesia verses no analgesia during labour on mother and fetus.Methods: Here in this study we have assessed effect of epidural analgesia on mother and fetus. Total we have taken 60 women in age group of 20-26 years with full term pregnancy (37-42 weeks). Those who have entered spontaneous labour with vertex presentation, without any previous uterine surgery, clinically adequate pelvis. We had divided these women in 2 groups, 30 were given epidural analgesia and 30 without any analgesia. Variables recorded were pain score during labour using VAS, duration of labour during each stage, mode of delivery, Apgar score of newborn at 1 minute and 5 minutes.Results: Present study shows that duration of first stage of labour in epidural and non-analgesia group are same. Second stage of labour is prolonged in epidural group than non-analgesia group. Both groups had normal APGAR score. Epidural analgesia is not associated with any change in mode of delivery. Visual analogue scale is good with epidural analgesia.Conclusions: There was no significant difference in first stage of labour in both group. Second stage of labour was slightly prolonged in EA group than control, but it was less than two hours. No harmful neonatal outcome in epidural analgesia.


2019 ◽  
Vol 131 (4) ◽  
pp. 840-849 ◽  
Author(s):  
Brandon M. Togioka ◽  
Katherine M. Seligman ◽  
Megan K. Werntz ◽  
N. David Yanez ◽  
Lorna M. Noles ◽  
...  

Abstract Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New Background Hispanic women choose epidural labor analgesia less commonly than non-Hispanic women. This may represent a healthcare disparity related to a language barrier and inadequate opportunities for labor analgesia education. It was hypothesized that a language-concordant, educational program regarding labor epidurals would improve epidural utilization in two independent cohorts of Hispanic and non-Hispanic women. Methods A randomized controlled trial, blinded to anesthesia, nursing, and obstetric providers, was completed at an academic hospital (February 2015 to February 2017). Two cohorts of Medicaid beneficiaries of Hispanic (English- and/or Spanish-speaking) and non-Hispanic ethnicity were enrolled concurrently. The patients were randomized to routine care alone or routine care and an additional educational program comprised of three components: a video show, corresponding pamphlet, and in-person counseling. The primary endpoint was use of epidural labor analgesia. The secondary endpoint was change in response before and after delivery on common misconceptions based on a 12-point epidural questionnaire. Results Hispanic women randomized to the intervention group were 33% more likely to choose epidural analgesia compared to the routine care group (40 of 50 [80%] vs. 30 of 50 [60%]; risk ratio, 1.33 [95% CI, 1.02 to 1.74]; P = 0.029). For the non-Hispanic cohort, no difference was detected in epidural use between the intervention and routine care groups (41 of 50 [82%] vs. 42 of 49 [86%]; risk ratio, 0.96 [95% CI, 0.80 to 1.14]; P = 0.62), but the study was underpowered to determine a result of no difference. Patients assigned to the intervention had a greater improvement in epidural understanding compared with routine care, among both Hispanic (2.26 vs. 0.74, respectively; difference in change from baseline, 1.52 [95% CI, 0.77 to 2.27]; P &lt; 0.001) and non-Hispanic (1.36 vs. 0.33, respectively; difference in change from baseline, 1.03 [95% CI, 0.23 to 1.75]; P = 0.005) cohorts. There were no adverse events during the trial. Conclusions The educational program increased epidural use among Hispanic women. The educational program reduced misconceptions regarding epidural analgesia in both Hispanic and non-Hispanic cohorts.


2021 ◽  
pp. 10-13
Author(s):  
R.Shanthi Malar ◽  
V. Vijayalakshmi ◽  
P. Thenmozhi

BACKGROUND:Pain relief during labour is an important component of modern obstetric care and can be produced by neuraxial, systemic or inhalational analgesia. Recent meta-analyses have supported epidural analgesia as the most efficacious technique.A good labour analgesia should aim at good pain relief during delivery process,at the same time not causing foetal acidosis,ensures safe for both mother and the baby. AIM OF THE STUDY:To study the influence of epidural analgesia on maternal and neonatal outcome MATERIALS AND METHODS:The study was conducted in the depar tment of Obstet r ics and Gynecology,GOVT.Stanley Medical College,Govt.RSRM LYING IN HOSPITAL,CHENNAI over a period of eight months from July 2019 to February 2021. The study was performed in 120 selected subjects. The study subjects were divided based on intervention – labour analgesia into 2 study groups. In this study,change in vital parameters,fetal heart rate,assessment of pain score,Duration of first and second stage of labour,mode of delivery,APGAR score and the need for NICU admission were noted and recorded.Any complications during the course of labour were also recorded. RESULTS:In this study,there was no significant difference in the mean duration of first and second stage of labour in both the study and control groups.The mean Apgar score of babies at one minute was 7.02 and at 5 minutes was 8.07 in the labour analgesia group and showed no significance.Maternal satisfaction for the effect of epidural analgesia,60.00% of the patients of epidural analgesia, the incidence of satisfactory/very satisfactory experience was meaningfully and significantly more in labour analgesia group subjects compared to control group subjects by 30 % with a 2 fold increase. CONCLUSION: As per this study labour analgesia using neuroaxial blockade technique are more likely to encounter increasing maternal satisfaction and good quality labour pain reduction.


2008 ◽  
Vol 126 (2) ◽  
pp. 102-106 ◽  
Author(s):  
Giane Nakamura ◽  
Eliana Marisa Ganem ◽  
Norma Sueli Pinheiro Módolo ◽  
Ligia Maria Suppo de Souza Rugolo ◽  
Yara Marcondes Machado Castiglia

CONTEXT AND OBJECTIVE: Previous studies have led to speculation that the association between ropivacaine and clonidine might be more effective than ropivacaine alone. We examined the maternal-fetal effects of two pharmacological approaches: a low dose of ropivacaine or a lower dose of ropivacaine plus clonidine for epidural analgesia during labor. DESIGN AND SETTING: Prospective study at Department of Anesthesiology, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista. METHODS: Thirty-two pregnant women in American Society of Anesthesiologists physical status I and II randomly underwent epidural analgesia using 15 ml of ropivacaine 0.125% (R group) or 15 ml of ropivacaine 0.0625% plus 75 µg clonidine (RC group). Pain intensity, sensory block level, latency time, motor block intensity, duration of labor analgesia and duration of epidural analgesia were evaluated. The newborns were evaluated using Apgar scores and the Amiel-Tison method (neurological and adaptive capacity score). RESULTS: There were no statistically significant differences between the groups regarding pain score, sensory block level, duration of epidural analgesia or Apgar score. The latency time, duration of labor analgesia and motor block were R group < RC group. The half-hour and two-hour neurological and adaptive capacity scores were higher in the R group. All of the R group newborns and 75% of the RC group newborns were found to be neurologically healthy at the 24-hour examination. RESULTS: There were no statistically significant differences between the groups regarding pain score, sensory block level, duration of epidural analgesia or Apgar score. The latency time, duration of labor analgesia and motor block were R group < RC group. The half-hour and two-hour neurological and adaptive capacity scores were higher in the R group. All of the R group newborns and 75% of the RC group newborns were found to be neurologically healthy at the 24-hour examination. CONCLUSION: Both low-dose ropivacaine and a lower dose plus clonidine relieved maternal pain during obstetric labor. Newborns of mothers who received only ropivacaine showed better neurological and adaptive capacity scores.


2000 ◽  
Vol 92 (6) ◽  
pp. 1588-1593 ◽  
Author(s):  
Catherine Fischer ◽  
Pierre Blanié ◽  
Envel Jaouën ◽  
Christophe Vayssière ◽  
Ismaël Kaloul ◽  
...  

Background This study compared the administration of 0.1% ropivacaine and 0.5 microg/ml sufentanil with that of 0.1% bupivacaine and 0.5 microg/ml sufentanil via patient-controlled epidural analgesia route during labor. Methods Two hundred healthy pregnant women at term with a single fetus with a vertex fetal presentation were randomized in a double-blind fashion to receive either 0.1% ropivacaine and 0.5 microg/ml sufentanil or 0.1% bupivacaine and 0.5 microg/ml sufentanil using a patient-controlled epidural analgesia pump (5-ml bolus dose, 10-min locked-out period, no basal infusion). Pain score on a visual analog scale, Bromage score (0-3), level of sensory block, patient-controlled epidural analgesia ratio, drug use, supplemental boluses, and side effects were recorded at 30 min and then hourly. Mode of delivery, duration of first and second stages of labor, umbilical cord pH, Apgar scores of the newborn, and a measure of maternal satisfaction were recorded after delivery. Results No differences were seen between the two groups for pain scores on a visual analog scale during labor, volume of anesthetic solution used, mode of delivery, or side effects. Motor block during the first stage of labor was significantly less in the ropivacaine group than in the bupivacaine group (no motor block in 97.8 of patients vs. 88.3%, respectively; P &lt; 0.01). Duration of the second stage of labor was shorter in the ropivacaine group (1.3 +/- 1.0 vs. 1.5 +/- 1.2 h [mean +/- SD]; P &lt; 0.05). Maternal satisfaction was greater in the bupivacaine group (91 +/- 13 mm for contraction, 89 +/- 19 mm for delivery on a visual scale: 0 = not satisfied at all, 100 = fully satisfied) than in the ropivacaine group (84 +/- 21 and 80 +/- 25 mm; P &lt; 0.0001). Patients in the ropivacaine group requested more supplemental boluses to achieve analgesia during the second stage of labor than those in the bupivacaine group (29.7 vs. 19.8%, respectively, requested one or more supplemental boluses; P &lt; 0.05). Conclusions Delivered as patient-controlled epidural analgesia, 0.1% ropivacaine and 0.5 microg/ml sufentanil produce less motor block but are clinically less potent than 0.1% bupivacaine and 0.5 microg/ml sufentanil.


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