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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAga Khan University

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nulliparous / Multiparous women

Age >18 years

ASA 1 & 2

Singleton vertex presentation

Disqualifiers

Major cardiac disease

History of chronic pain

Chronic opioid user

Platelet count < 70 x 109/L

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dural puncture epidural

    Procedure/Surgery

    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.

  • Standard Epidural Technique

    Procedure/Surgery

    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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: DPE groupActive comparator 1 intervention
Group B: SET groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 30 minutes of initiation of infusion
2

Need for catheter adjustment

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

Time frame
At 30 minutes of initiation of infusion

Secondary outcomes

1

Patient Satisfaction

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.

Time frame
At 30 minutes of initiation of infusion
2

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

Time frame
At 30 minutes after the initiation of infusion

Other outcomes

Sponsors and contacts

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