Power Doppler Ultrasonography in Localization of Epidural Catheter

NCT06019039 | Completed

• 1 other identifier: m649
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural anesthesia is a widely used method for pain relief which is useful in various settings. Identification of needle entry into the epidural space (EDS) is performed most using a loss of resistance (LOR) technique, which was described in 1921 by Sicard and Forestier, and has remained largely unchanged since. Hysterectomy operations anesthesia and analgesia rely heavily on proper needle placement technique. A noninvasive approach to confirm the correct position of the epidural needle prior to injection of local anesthetics into the epidural space, would thus be beneficial. Ultrasound (US) is a noninvasive approach increasingly used in anesthesia practice. The use of color flow Doppler (CFD) may further aid in defining the epidural space. The aim of current study is to detect and confirm site of epidural catheter in hysterectomy by using color flow doppler ultrasonography.

Conditions

Uterine Diseases

Keywords

Power doppler ultrasonography; Epidural catheter; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Visualization of flow relative to the interspace insertion level by color flow Doppler

  Yes or no

  1 minute after insertion of epidural catheter

Secondary Outcomes (6)

• Level of epidural catheter insertion

  1 minute after insertion of epidural catheter

• Verbal numerical rating scale

  8 hours postoperatively

• Duration of epidural analgesia

  First 24 hours postoperatively.

• Incidence of patchy or asymmetric block

  15 minutes after insertion of epidural catheter

• Maximum upper sensory block to ice as charted by the nurse

  15 minutes after insertion of epidural catheter

Other Outcomes (5)

• Age

  1 hour preoperatively

• Height

  1 hour preoperatively

• Weight

  1 hour preoperatively

Study Arms (1)

Epidural Ultrasound group

After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter.

Drug: Normal Saline Flush; Device: Doppler

Interventions

Normal Saline Flush DRUG

Five milliliters of sterile saline will be administered as a flush through the needle while recording the color flow doppler images. The same procedure will be repeated with a slow injection of 5 mL of saline. The speed of injection will not be standardized.

Also known as: 0.9% isotonic normal saline

Epidural Ultrasound group

Doppler DEVICE

All color flow Doppler images will be performed with a Phillips CX50 ultrasound machine using a 5.0 MHz a low frequency curvilinear US probe. A two-dimensional transverse interspinous view was used to visualize the posterior complex (ligamentum flavum, epidural space and dura). After loss of resistance to normal saline, the color flow Doppler function will be turned on to examine flow through the epidural needle tip. The ultrasound probe was positioned in the transverse axis slightly below the epidural needle but still in the interspinous space .

Also known as: Color flow Doppler

Epidural Ultrasound group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary gynecology and obstetric care clinic in Fayoum university hospital

You may qualify if:

• Women who will have hysterectomy operation under epidural analgesia
• Women with the epidural catheter still in place
• American Society of Anesthesiologists (ASA) physical status I, II
• Age range from 30 and 70 years.

You may not qualify if:

• Patient refusal
• History of allergy to one of the study drugs.
• Any contraindication to regional anesthesia such as local infection or bleeding disorders

Sponsors & Collaborators

• Yasser S Mostafa, MD: lead
• Fayoum University Hospital: collaborator

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

• Liu Y, He S, Zhou S. Effect of general anesthesia combined with epidural anesthesia on circulation and stress response of patients undergoing hysterectomy. Am J Transl Res. 2021 May 15;13(5):5294-5300. eCollection 2021.

  PMID: 34150121 BACKGROUND

• Elsharkawy H, Sonny A, Chin KJ. Localization of epidural space: A review of available technologies. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):16-27. doi: 10.4103/0970-9185.202184.

  PMID: 28413269 BACKGROUND

• Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.

  PMID: 30482003 BACKGROUND

MeSH Terms

Conditions

Uterine Diseases

Interventions

Echocardiography, Doppler; Echocardiography, Doppler, Color

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ultrasonography, Doppler, Color; Ultrasonography, Doppler, Duplex

Study Officials

• Atef M Sayed, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

• Abeer S Goda, MD

  Fayoum University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 31, 2023
• Study Start: April 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: March 15, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)