Clinical trial NCT06287047: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block
Official title: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dural Puncture Epidural Technique
Keywords: Dura
Dural puncture
epidural
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle.
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications.

Detailed description: * 81 patients primigravida parturients (ASA II) in active labor
* uncomplicated pregnancy
* Cephalic presentation
* Cervical dilatation \<5 cm

Exclusion criteria:

* Allergy to local anesthetics.
* Bleeding disorders
* Low platelet count
* Local or systemic sepsis
* Prior surgery in lumbosacral spine
* Patient's refusal.

Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups:

Group CE (n=27): Conventional epidural. Group DPE-25 (n=27): Dural puncture epidural with 25-gauge spinal needle. Group DPE-27 (n=27): Dural puncture epidural with 27-gauge spinal needle.

Randomization was done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series were unknown to the investigators and the group assignment was kept in a set of sealed envelopes, each bearing only the case number on the outside.

Full medical and surgical history were taken. Laboratory investigations were revised. Visual analogue scale was educated to the patient before the start of the operation.

One liter of lactated Ringer's solution was infused IV over 15 min during the neuraxial procedure.

The procedure was performed in the seated position. Parturients with VAS \< 5 were excluded.

The procedure was performed by a senior anesthesia resident.

Before administering medications through the epidural catheter, subarachnoid, intravascular and subdural placement had to be ruled out.

After 5 min of the first initial bolus dose, adequacy of analgesia was assessed.

Analgesia was considered adequate if VAS score is ≤3. Onset of analgesia was defined as from time of first bolus dose to time of achieving VAS ≤3.

Patient with VAS score \>3; considered failed block and were excluded from the study.

Analgesia was evaluated by a blinded observer assessing visual analog scale (VAS) pain scores, onset of analgesia, sensory level, and motor blockade.

The primary outcome was the onset of analgesia (defined as duration from injection of the first initial epidural bolus to attainment of VAS \<3).

Other data collected are:

1. Patients' demographic data.
2. Obstetrics data.
3. Onset of analgesia (attainment of VAS \<3).
4. HR and MABP (baseline, every 5 minutes until 15 mins, a every 15 mins till 1 hour and then every 1 hour till delivery).
5. Visual analogue scale (VAS) with hemodynamics.
6. Assessment of sensory level after 30 mins of the block.
7. Assessment of Sacral block during the 1st 30 minutes.
8. Assessment of motor block through the modified bromage scale
9. Occurrence of side effects as: Hypotension, bradycardia, nausea, vomiting and pruritis ,PDPH, nerve injury.

Eligibility criteria: Inclusion Criteria:

* ASAI \& II parturient in active labor
* Uncomplicated pregnancy with vertex presentation
* Willing to participate in the study.

Exclusion Criteria:

* Patient's refusal
* Coagulopathy (INR\> 1.5 and platelets \< 80,000)
* Allergy to local anesthetics.
* Prior surgery in lumbosacral spine.

Primary outcomes:
measure: Onset of analgesia
timeFrame: 20 minutes
Secondary outcomes:
measure: Degree of analgesia
timeFrame: 5 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medidcne, Cairo Univerisity
Study officials:
References: