A Phase 2/3 interventional study of Epidural analgesia with bupivacaine and dexmedetomidine in Labor Pain, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Assiut University · Phase 2/3, Interventional, and Prevention
The aim of this study is to compare two modes of labour epidural analgesia:
programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour
Labour although varies with the individual may be the most painful experience, any women may ever encounter. Concerns about pain in labour are as old as mankind. Pain can make patients feel uncomfortable and become sleepless and agitated. Pain also stimulates the sympathetic nervous system, which causes increase in the heart rate, blood pressure, sweat production, endocrine hyper-function, and delays the patients' prognosis. Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased. The ideal labor analgesia should be based on maternal and child safety and should have a fast-acting good analgesic effect and less adverse reaction. Different adjuvants such as opioids and α2-adrenergic agonists were added to local anesthetics to improve the quality of intraoperative and postoperative analgesia. Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia . Dexmedetomidine have several beneficial actions during perioperative period. It decreases the sympathetic tone with attenuation of the neuroendocrine and hemodynamic response to anesthesia and surgery, reduce anesthetic and opioid requirement, cause sedation and analgesia. Dexmedetomidine was used to enhance the analgesic property of local anesthetics like lidocaine, bupivacaine and ropivacaine. The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2-adrenergic agonist. Maintenance of epidural analgesia involved intermittent provider , administered boluses, patient-controlled epidural analgesia, and continuous epidural infusions with or without patient-controlled epidural analgesia. Continuous epidural infusion is the standard application setting for epidural infusion, highly effective, and provides consistent analgesia. however, is associated with greater local anesthetic consumption . A newer approach to maintenance of labor epidural analgesia involves the administration of programmed intermittent epidural boluses with patient-controlled epidural analgesia dosing for breakthrough pain. Earlier studies have suggested that programmed intermittent epidural boluses may be superior to continuous epidural infusion for labor analgesia and may be associated with a reduction in local anesthetic requirement, decreased motor blockade, lower risk of instrumental deliveries, and improved patient satisfaction. This may be related to increased pressure generated during automated boluses, resulting in improved distribution of the local anesthetic in the epidural space .
409 studies on the registry are indexed under Labor Pain; 69 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 336 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).
Drug: Epidural analgesia with bupivacaine and dexmedetomidine
After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).
Drug: Epidural analgesia with bupivacaine and dexmedetomidine
Drug pages: Bupivacaine · Dexmedetomidine
Epidural analgesia with bupivacaine and dexmedetomidine
total volume of local anesthetic
total volume of local anesthetic received through patient controlled epidural analgesia per hour
Time frame: 24 hour
Ramsay sedation scale
Completely awake or asleep and not responsive to any stimulus
Time frame: 24 hour
Heart rate
Beat per minute
Time frame: 24 hour
Blood Pressure
mmHg
Time frame: 24 hour
Likert scale for satisfaction
very satisfied or very dissatisfied
Time frame: 24 hour
Bromage score for motor block
free movement of legs and feet or unable to move legs and feet
Time frame: 24 hour
Started May 2023 (actual). Primary completion is estimated for Mar 2025, 21 months after the start.
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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Dexmedetomidine