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

NCT05056142 — Not applicable, Completed, 100 participants, Ain Shams University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05056142
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, other
Enrollment	100 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Pregnancy Related
Interventions	Epidural Anesthesia, Spinal Analgesia (Procedure)
Dates	start 2021-09-14, primary completion 2022-10-01, completion 2022-10-01, first posted 2021-09-24, last updated 2022-12-07
Locations	1 site in Egypt

-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.

Expand all sections · Collapse all

+Arms and interventions

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

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Sex: Female, ages: 18 Years to 40 Years

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

+Locations (1)

Facility	City	Country	Status
Ain Shams University Hospitals	Cairo	Egypt

My Notes

Public

To Read Reading Read