Dural Puncture Epidural Technique During Cesarean Section

NCT ID: NCT06184425

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-12-08

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of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 27 G Whitacre needle

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

\- 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.

Intervention Type: PROCEDURE

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

\- 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reham Ali Abdelhaleem Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Reham Ali Abdelhaleem Abdelrahman

Anesthesia lecturer M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Reham Ali Abdelhaleem Abdelrahman

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IF-2023

Identifier Type: -

Identifier Source: org_study_id