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

Not Applicable

Recruiting

• Conditions: Quality Health Care

• Registration Number: NCT06653036
• Lead Sponsor: Aga Khan University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-22
• Study Start: 2024-11-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Assessment	At 30 minutes of initiation of infusion	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.
Need for catheter adjustment	At 30 minutes of initiation of infusion	Persistence of either unilateral pain score (NRS) of \>4, thirty minutes after 2 boluses of 10ml of 0.125% Bupivacaine

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	At 30 minutes of initiation of infusion	Patient Satisfaction using a five-point satisfaction score as follows: Satisfied (score 1 to 3) ------------- Unsatisfied (score 4 to 5) -----------; 1. perfect: the patient did not experience any pain at all,; 2. very satisfied: helped relieve most of her pains,; 3. satisfied: the epidural procedure relieved major pains, but she still experienced minor pains,; 4. 4not satisfied: the epidural procedure helped only a bit a; 5. 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.
Assessment of the level of motor Block	At 30 minutes after the initiation of infusion	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

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan