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37 active trials for Labor Pain

Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery

Programmed Intermittent Epidural Bolus (PIEB) has become a standard technique for labour analgesia in many departments of anesthesia. Advantages to the former standard of care, continued epidural infusion (CEI), include reduced analgesic consumption , better maternal satisfaction and less occurrence of motor block . At Mount Sinai Hospital, the introduction of a bundle of changes in the management of labor analgesia including the use of PIEB, has resulted in an improvement of the quality of labor analgesia. This bundle of changes included labor catheter placement more often at L2/L3 interspace, more frequent use of fentanyl in the epidural loading dose, the implementation of a PIEB regimen and an increase in hourly baseline offer of local anesthetic. A recent before-and-after study conducted by the investigators, comparing the current practice with the previous practice, which was based on CEI, identified that the incidence of women experiencing pain >3 (scale 0-10) (40% vs 30%) and the number of nurse-administered top-ups (24% vs 3%) were significantly reduced. However, despite that significant improvement, some 30% of women undergoing epidural analgesia still experience pain NRS >3 (NRS scale 0-10) during either first or second stage of labor. Although the health care team attempts to manage epidurals as standardized as possible, there is some variation in practice resulting from the many stakeholders involved in the labor analgesia management, including anesthesiologists, obstetricians, nurses and patients. The investigators hypothesized that our most recent results may be explained by the lack of standardization of the management of epidural analgesia and that a standardized epidural catheter placement and a management algorithm may improve the efficacy of our epidural analgesia regimen. The aim of this pilot study is to test the feasibility and efficacy of the use of a standardized algorithm for the management of labor epidural analgesia based on a PIEB regimen.

Start: May 2021
Drug Concentration and Volume on Adequate Labor Analgesia With PIEB

Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]) via epidural catheter. Pain during the first stage of labor is primarily due to lower uterine segment and cervical stretching. The pain signals enter the spinal cord through sensory nerves at the T10 through L1 dermatomes. Pain signals from the late first state and second stage of labor also arise from the vagina and perineum. These signals travel with the pudendal nerve and enter the spinal cord at S2-S4. Thus, the anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that PIEB, in combination with PCEA, provide superior maintenance of labor analgesia (less need and longer time to provider intervention, lower local anesthetic consumption, less motor block, and improved patient satisfaction scores) than maintenance with a continuous infusion with PCEA.The mechanism for this difference is not known; however, one suggested mechanism is improved spread of the local anesthetic within the epidural space. Kaynar et al. injected methylene blue dye through a multi-orifice catheter using either a continuous infusion or intermittent bolus and the area of diffusion was measured on a piece of paper. The authors found that intermittent boluses were associated with a greater surface area of diffusion than continuous infusion. In a cadaver study, dye was injected into the lumbar epidural space, and cryomicrotome sections were taken.Dye flowed in rivulets through small channels in the epidural space, as opposed to moving as a unified front. The authors found dye injected at high pressures had more uniform spread through the epidural space, supporting the concept of intermittent epidural injection providing superior analgesia. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Recently we completed a double-blinded randomized control trial evaluating two bolus delivery rates, hypothesizing that those patients randomized to receive higher bolus delivery rates would have improved labor analgesia. However, no difference was found between groups.What is more, both groups had a mean cephalad sensory level to cold of T6. This sensory level is higher than the traditional goal of T10 (upper dermatome level of uterine innervation), but despite the adequate sensory level, a large number of patients required supplemental physician-delivered boluses of local anesthetic during labor. Forty percent of the women in the high-rate group and 36% of the low-rate group required a manual re-dose during labor. This suggests that either a higher volume, or higher concentration of local anesthetic (i.e., higher dose) is needed to maintain adequate labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

Start: January 2020