Clinical trial NCT06184425: Dural Puncture Epidural Technique During Cesarean Section
Official title: A Randomized Comparative Study Between 25-Gauge and 27-Gauage Pencil Point Spinal Needles During Dural Puncture Epidural Anaesthesia For Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Obstetric
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.

Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal \&fetal complications.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women (ASAI\&II) with singleton vertex presentation cephalic presentation foetus at 38 to 42 weeksꞌ gestation.
* Age: 20-35 years old.
* Weight: 57-85 Kg.
* Height: 155-170cm.

Exclusion criteria

* Non-elective CS.
* Known foetal anomalies.
* Patient refusal or uncooperative patients.
* Patients with history of drug abuse and maternal diseases (i.e. diabetes mellitus, cardiac disease, heart block/dysrhythmia, hypertension, chronic obstructive respiratory disease, preeclampsia, eclampsia, placenta previa, placental abruption, coagulation abnormalities or hematological diseases).
* Spinal deformities, previous spinal surgeries, allergy to amide type of local anesthetics, localized skin sepsis at spinal lumbar region, neurological diseases, peripheral neuropathy, neuromuscular diseases, psychiatric diseases, hepatic and renal diseases, metabolic and endocrinal diseases and Raynaud's disease.
* Severe hypovolemia, severe hemodynamic instability and patients with anemia (Hb \<10 gm %).
* Morbidly obese (BMI \> 35 kg/m2) patients.
* Those who are very short (\<150cm) or very tall (\>170 cm).
* Patients on therapy with adrenergic receptor antagonist, anticoagulants, calcium channel blocker, and/or ACE inhibitor.

Primary outcomes:
measure: was the onset time to surgical anesthesia
timeFrame: up to 20 minutes after local anesthetic injection
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Reham Ali Abdelhaleem Abdelrahman
Study officials:
References: