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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05056142
Other study ID # FMASU R 155/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2021
Est. completion date October 1, 2022

Study information

Verified date December 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation = 6 cm by examination) - Aged 18-40 years old - Single, term pregnant with normal fetal heart rate - Request neuroaxial analgesia Exclusion Criteria: - Parturient who refuses to participate, - American Society of Anesthesiologists (ASA) physical status >II, - Body mass index more than 35 kg/m2 - Severe pre-eclampsia or eclampsia - Uncontrolled thyrotoxicosis - Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy) - Increased intracranial tension due to a space-occupying lesion - Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery. - Hypersensitivity to the study drugs - Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epidural Anesthesia
Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 µg/mL.
Spinal Analgesia
Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 µg of fentanyl in a 2 ml volume.

Locations

Country Name City State
Egypt Ain Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The time to perform the block The time from the preparation of the block until the full injection of anesthetic drugs, Intraoperative
Secondary Mean arterial blood pressure (MAP) MAP will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor Intraoperative
Secondary Heart rate (HR) HR will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor Intraoperative
Secondary Number of participnts with Postoperative nausea and vomiting (PONV) PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV' First 24 hours postoperatively
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