Aga Khan University
Karachi, Sindh, Pakistan
Location status: Recruiting
Recruiting
NCT Number: NCT06653036
Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Dural puncture epidural
ProcedureThe Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle.
Standard Epidural Technique
ProcedureThe 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.
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
Time frame: 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) -----------
- 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.
-
Assessment of the level of motor Block
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Aga Khan University
Other
Registry information
Official study title
Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 22, 2024
- Registry last updated
- Jan 30, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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