Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion

NCT ID: NCT06653036

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-28

Study Completion Date

2025-12-31

Brief Summary

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The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are

* Effectiveness and quality of labor analgesia
* Frequency of catheter adjustments
* Need for catheter replacements
* Incidence of failed regional anesthesia requiring conversion to general anesthesia

Detailed Description

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Conditions

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Quality Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DPE group

Participants who receive the dural puncture epidural (DPE) for labor analgesia.

Group Type ACTIVE_COMPARATOR

Dural puncture epidural

Intervention Type PROCEDURE

The Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle.

SET group

Participants who will be receiving standard epidural technique (SET) for labor analgesia.

Group Type ACTIVE_COMPARATOR

Standard Epidural Technique

Intervention Type PROCEDURE

The Standard Epidural Technique is usually performed by identifying the epidural space using the loss of resistance technique and threading the epidural catheter in the epidural space for administration of analgesic drugs.

Interventions

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Dural puncture epidural

The Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle.

Intervention Type PROCEDURE

Standard Epidural Technique

The Standard Epidural Technique is usually performed by identifying the epidural space using the loss of resistance technique and threading the epidural catheter in the epidural space for administration of analgesic drugs.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Nulliparous / Multiparous women
* Age \>18 years
* ASA 1 \& 2
* Singleton vertex presentation
* Gestational age 37-42 weeks
* Parturient with established labor and pain score ≥ 3

Exclusion Criteria

* Major cardiac disease
* History of chronic pain
* Chronic opioid user
* Platelet count \< 70 x 109/L
* spinal cord anomalies
* Use of anticoagulants
* Allergic to local anesthetics
* Patients with preeclampsia/ eclampsia
* Known fetal anomalies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Samina Ismail

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aga Khan University

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Samina Ismail, MBBS, FCPS

Role: CONTACT

+922134864331 ext. 4331

Sehrish Khan, MBBS, FCPS

Role: CONTACT

+923347126366

Facility Contacts

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Samina Ismail, MBBS, FCPS

Role: primary

+922134854331 ext. 4331

Other Identifiers

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2024-10424-31009

Identifier Type: -

Identifier Source: org_study_id

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