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Color Doppler to Confirm Epidural Catheter Positioning in Parturient

M

Menoufia University

Status

Completed

Conditions

Labor Pain

Treatments

Device: Color Doppler

Study type

Interventional

Funder types

Other

Identifiers

NCT05606952
10/2022ANET1-2

Details and patient eligibility

About

The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Full description

patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

Enrollment

194 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

Exclusion criteria

  1. Patients suffering from coagulopathy.
  2. Patients on recent anticoagulant therapy.
  3. Patients suffering from sepsis or with local sepsis at the insertion site.
  4. Patients with platelet count less than 100,000/dl.
  5. Patient refusal.
  6. Patient with known allergy to local anesthetic drugs
  7. Patients delivered by forceps.
  8. Patients who have undergone a cesarean section delivery.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

194 participants in 2 patient groups

Group (C)
Active Comparator group
Description:
patients with BMI less than 35
Treatment:
Device: Color Doppler
Group (O)
Active Comparator group
Description:
patients with BMI more than 35
Treatment:
Device: Color Doppler

Trial contacts and locations

1

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Central trial contact

rabab M habeeb

Data sourced from clinicaltrials.gov

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