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Obstetric Pain clinical trials

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NCT ID: NCT06429111 Completed - Labor Pain Clinical Trials

Effectiveness and Safety in Maternal and Neonatal Outcomes in Water Birth.

Start date: June 6, 2020
Phase:
Study type: Observational

Childbirth is a unique and non-transferable experience in the life of a woman, her partner and her family. It is a very intense process that requires accompaniment and, in the vast majority of cases, requires analgesic support in order to overcome this life event in an optimal and atraumatic way. Among the analgesic methods for pain relief during the labor process, there are pharmacological and non-pharmacological methods. From the evidence we know that the most effective pharmacological method is epidural analgesia (EA), while the most recognized non-pharmacological method is immersion in hot water (bathtub) for dilatation and delivery, called waterbirth(WB) At present there is controversy and doubts about the increase in the number of interventions involving the use of epidural analgesia, but there is also controversy about the safety of the use of water, especially in those processes where the birth ends in water. Given the popularity of these two methods, the aim is to study and compare the maternal and neonatal outcomes derived from the use of both methods in order to provide greater knowledge to women in their decision making.

NCT ID: NCT06355271 Not yet recruiting - Obstetric Pain Clinical Trials

Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

MoFe
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery

NCT ID: NCT06304246 Not yet recruiting - Postoperative Pain Clinical Trials

The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section

Start date: March 1, 2024
Phase:
Study type: Observational

Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures. It is known that one of the most important factors affecting mothers' approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients' perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors. We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels. In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use.

NCT ID: NCT06266767 Not yet recruiting - Analgesia Clinical Trials

Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia

PIEB
Start date: February 20, 2024
Phase: Phase 4
Study type: Interventional

Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score.

NCT ID: NCT06055686 Not yet recruiting - Anesthesia, Local Clinical Trials

The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

Start date: January 2024
Phase: N/A
Study type: Interventional

The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.

NCT ID: NCT05498025 Completed - Pain, Acute Clinical Trials

The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery

Start date: February 21, 2023
Phase: N/A
Study type: Interventional

Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation. Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery. Methods: This is a prospective single arm interventional pilot study.

NCT ID: NCT05447455 Completed - Obstetric Pain Clinical Trials

TAP Block vs LAWI for Analgesia Post-cesarean Section

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours

NCT ID: NCT05196256 Not yet recruiting - Analgesia Clinical Trials

Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

This will be a prospective, randomized, double blind, controlled clinical trial. Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Technical and pharmacological advances in recent years have made it possible to provide patients with high quality analgesia with individualized control, associated with extremely limited motor block. However, sometimes this technique fails due to a prolonged delay in action, or insufficient sensory block. An alternative technique has become popular in recent years, the combined peri-spinal anesthesia also called sequential (CSE). It combines the administration of low doses of local anesthetics and/or intrathecal opiates before the placement of the catheter in the epidural space and the use of the catheter as in a classical technique. This technique would allow a more rapid onset of analgesia, a more complete relief of the patient, and a lower degree of failure. However, it could be accompanied by a greater risk of maternal hemodynamic instability, fetal bradycardia, and a longer expulsion period. In addition, the effectiveness of the catheter injection can only be assessed when the effects of the spinal injected drugs have worn off. In order to limit these undesirable effects, it has been proposed to perform a dural puncture as performed in the sequential technique but without intrathecal drug injection (DPE). In this way, a "tunnel" is created, allowing the diffusion of drugs from the epidural space to the subarachnoid space. Thus, the initiation of anesthesia would be faster with a lower risk of lateralization compared to the standard epidural, also allowing a decrease in the consumption of local anesthetics and without the undesirable effects of the sequential. Although this technique recently introduced in obstetrical analgesia appears promising, very few studies to date have evaluated its effectiveness and safety. The hypothesis of the study is that the Epidural with Dural puncture (DPE) provides a higher quality of analgesia than standard epidural while having fewer adverse effects than combined epidural, in particular a lower incidence of maternal hypotension. The primary objectives are: - testing the quality of analgesia with DPE compared to PE and CSE. This will be assessed by determining the area under the curve of Visual Analog Scale (VAS) measurements observed from the beginning of obstetric analgesia and throughout the delivery. - testing the rate of maternal hypotension with DPE compared with PE and CSE, with hypotension defined as a decrease in systolic blood pressure (SBP) greater than 15% from the SBP measured at the time of the parturient arrival in the labor room, a SBP < 90 mmHg, or any decrease in pressure associated with disabling symptomatology (dizziness, yawning, nausea). For this purpose, the investigators will randomize a total of 90 patients, 30 in each of the groups. The patients will receive one of the three techniques, all of them will benefit from the administration of epidural analgesia with low concentration local anesthetics and opioids on a Intermittent bolus modus (PIB). Patients assigned to the combined spinal epidural modus will receive a injection of a small quantity of local anesthetics and opioids (Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg) in the intrathecal space. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications. Data collection will take place before starting the locoregional anesthesia technique, at the moment when the anesthetists non blinded leaves the room, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after the start of the analgesia and at the moment of the expulsion of the baby. Patients and care providers will be blinded to which technic is being given. Data will be statistically analyzed using area under the curve and two-dimension variance analysis.

NCT ID: NCT04983511 Not yet recruiting - Anesthesia, Local Clinical Trials

Electrical Epidural Stimulation Test for Detecting Epidural Catheter Reactivation in Obstetric Population

Start date: June 2024
Phase: N/A
Study type: Interventional

Following labor, epidural or combined spinal-epidural (CSE) catheters are kept in place and deactivated. However, many women opt for procedures such as tubal ligation, which may require epidural anesthesia as a method of pain relief. Our study aims to confirm the ability to predict reactivation of epidural catheter in postpartum females through the electrical epidural stimulation test (EST) which was first described by the PI of this study approximately 20 years ago.

NCT ID: NCT04728048 Recruiting - Anesthesia Clinical Trials

Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia

DPE
Start date: January 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective randomized controlled study is to compare the number of physician top-up interventions during the first stage of labour between two different neuraxial analgesia techniques : the dural puncture epidural and the standard epidural.