NCT06653036

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 28, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

September 26, 2024

Last Update Submit

January 28, 2025

Conditions

Quality Health Care

Keywords

Quality Labor AnalgesiaMaternal Adverse Events

Outcome Measures

Primary Outcomes (2)

  • Pain Assessment

    Pain assessment by using numerical rating pain score and assessing sensory level. Numerical rating score: Pain Assessment: Numerical rating scale (NRS) 0 to 10. 0=no pain, 1-3 =mild pain, 4-7 =Moderate pain, 8-10= severe pain. Assessing sensory level: Testing will be done on specific dermatomes and will be compared bilaterally by either using one of these tests. 1. Light Touch Test: Dab a piece of cotton wool on an area of skin. 2. Temperature test: by using Ice on specific dermatomes and ask the patient if they feel cold sensation 3. Pinprick Test for pain sensation - Gently touch the skin with the pin ask the patient whether it feels sharp or blunt.

    At 30 minutes of initiation of infusion

  • Need for catheter adjustment

    Persistence of either unilateral pain score (NRS) of \>4, thirty minutes after 2 boluses of 10ml of 0.125% Bupivacaine

    At 30 minutes of initiation of infusion

Secondary Outcomes (2)

  • Patient Satisfaction

    At 30 minutes of initiation of infusion

  • Assessment of the level of motor Block

    At 30 minutes after the initiation of infusion

Study Arms (2)

DPE group

ACTIVE COMPARATOR

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

Procedure: Dural puncture epidural

SET group

ACTIVE COMPARATOR

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

Procedure: Standard Epidural Technique

Interventions

Dural puncture epiduralPROCEDURE

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.

DPE group
Standard Epidural TechniquePROCEDURE

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.

SET group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

RECRUITING

Central Study Contacts

Samina Ismail, MBBS, FCPS

CONTACT

+922134864331samina.ismail@aku.edu

Sehrish Khan, MBBS, FCPS

CONTACT

+923347126366sehrish.khan@aku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 22, 2024

Study Start

November 28, 2024

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)