Obstetric Placement Study Using EST
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University
About this trial
Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females, 18 years and older
American Society of Anesthesiologists physical status I or II
Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)
Disqualifiers
Contraindication to regional anesthesia
Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
Use of sedatives or opioids
Abnormal vertebrae anatomy
Trial design
Design model
Sequential
Treatments tested in this trial
Electrical Epidural Stimulation Test (EST)
Diagnostic testEST measures sensory/motor responses
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Electrical Epidural Stimulation Test (EST)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Electrical Epidural Stimulation Test
Investigate the ability of the electrical epidural stimulation test (EST) to determine the position of the epidural catheter anesthesia for labour analgesia after low-dose anesthetic as compared to the gold standard of clinical assessment.
Time frame
Duration of EST test (approximately 1-2 hours)Secondary outcomes
1
Pain Scores
Patients will be asked for a pain score by research staff approximately 3 hours following placement of the epidural catheter and low-dose anesthetics are introduced. The pain scores will be on a scale from 0-10 with 0 representing no pain and 10 representing maximum pain.
Time frame
Approximately 3 hours following introduction of anesthetics through the catheter.Sponsors and contacts
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Source ClinicalTrials.gov