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

Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Quality Health Care
• Intervention / Treatment: Procedure: Dural puncture epidural; Procedure: Standard Epidural Technique

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samina Ismail, MBBS, FCPS; Phone Number: 4331 +922134864331; Email: samina.ismail@aku.edu
• Study Contact Backup: Name: Sehrish Khan, MBBS, FCPS; Phone Number: +923347126366; Email: sehrish.khan@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Aga Khan University
      • Contact: Samina Ismail, MBBS, FCPS; Phone Number: 4331 +922134854331; Email: samina.ismail@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DPE group; Participants who receive the dural puncture epidural (DPE) for labor analgesia.	Procedure: 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.
Active Comparator: SET group; Participants who will be receiving standard epidural technique (SET) for labor analgesia.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient Satisfaction using a five-point satisfaction score as follows: Satisfied (score 1 to 3) ------------- Unsatisfied (score 4 to 5) -----------; perfect: the patient did not experience any pain at all,; very satisfied: helped relieve most of her pains,; satisfied: the epidural procedure relieved major pains, but she still experienced minor pains,; 4not satisfied: the epidural procedure helped only a bit a; poor: the epidural procedure did not help at all. Scores from 1 to 3 were considered as the patient being satisfied with the labour epidural analgesia, and scores from 4 to 5 were regarded as the patient being unsatisfied with the labour epidural analgesia.	At 30 minutes of initiation of infusion
Assessment of the level of motor Block	The level of the motor block will be assessed using the modified Bromage score. Where, 1 =unable to flex feet or knees, 2 =able to flex feet only, 3 =s able to flex knees, 4 = detectable weakness in hip flexion, 5 = no weakness with hip flexion	At 30 minutes after the initiation of infusion

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Quality Labor Analgesia; Maternal Adverse Events
• Other Study ID Numbers: 2024-10424-31009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No