Dural Puncture Epidural Technique During Cesarean Section

NCT06184425 | Completed DMC

• 1 other identifier: IF-2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local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.

Conditions

Anesthesia, Obstetric

Outcome Measures

Primary Outcomes (1)

• was the onset time to surgical anesthesia

  was defined as the time from the end of the intraoperative epidural test dose injection \[the start of epidural extension anaesthesia (time zero on the stopwatch)\] to when the sensory block level reached the T6 dermatome bilaterally (when the patient could no longer feel sharp sensation at T6) (assessed bilaterally at the midclavicular line)

  up to 20 minutes after local anesthetic injection

Study Arms (2)

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

ACTIVE COMPARATOR

Procedure: Dural Puncture Epidural technique using pencil-point 27G Whitacre needle

Dural Puncture Epidural technique using 27 G Whitacre needle

EXPERIMENTAL

Procedure: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

Interventions

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle PROCEDURE

\- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 25-gauge pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.

Dural Puncture Epidural technique using 27 G Whitacre needle

Dural Puncture Epidural technique using pencil-point 27G Whitacre needle PROCEDURE

\- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 27-gauage pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reham Ali Abdelhaleem Abdelrahman: lead

Study Sites (1)

Reham Ali Abdelhaleem Abdelrahman

Cairo, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesia lecturer M.D.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: January 10, 2023
• Primary Completion: November 6, 2023
• Study Completion: December 8, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)