Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor

Pregnancy Related Clinical Trial

Official title:

Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056142
• Other study ID #: FMASU R 155/2021
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy Related

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