Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Aga Khan University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Pain Assessment
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
DPE group
Participants who receive the dural puncture epidural (DPE) for labor analgesia.
Intervention: Dural puncture epidural (Procedure)
SET group
Participants who will be receiving standard epidural technique (SET) for labor analgesia.
Intervention: Standard Epidural Technique (Procedure)
Outcomes
Primary Outcomes
Pain Assessment
Time Frame: 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
Time Frame: 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 Outcomes
- Patient Satisfaction(At 30 minutes of initiation of infusion)
- Assessment of the level of motor Block(At 30 minutes after the initiation of infusion)
Investigators
Samina Ismail
Professor
Aga Khan University