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

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05056142

Collaborator

(none)

100

Enrollment

Location

Arms

13.6

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Procedure: Epidural Anesthesia Procedure: Spinal Analgesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 14, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Epidural Anesthesia

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL

Procedure: Epidural Anesthesia

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.

Active Comparator: Spinal Anesthesia

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Procedure: Spinal Analgesia

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Outcome Measures

Primary Outcome Measures

The time to perform the block [Intraoperative]
The time from the preparation of the block until the full injection of anesthetic drugs,

Secondary Outcome Measures

Mean arterial blood pressure (MAP) [Intraoperative]
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
Heart rate (HR) [Intraoperative]
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
Number of participnts with Postoperative nausea and vomiting (PONV) [First 24 hours postoperatively]
PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV'

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amin Mohammed Alansary Amin Ahmed Helwa, Associate Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05056142

Other Study ID Numbers:

FMASU R 155/2021

First Posted:

Sep 24, 2021

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jul 8, 2022