Application of Real-time Ultrasound Guidance in Thoracic Epidural Catheter Placement

NCT07100769 | Recruiting DMC

• 1 other identifier: 23/2025/HĐ-ĐHYD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the success rate of real-time ultrasound-guided thoracic epidural catheter placement at the first attempt in patients who will undergo thoracic or abdominal surgeries. The main aims are to: Assess the success rate of first-attempt thoracic epidural catheter placement. Assess the procedure duration of real-time ultrasound-guided epidural catheter placement Participants will be managed according to the following protocol The patient will have real-time ultrasound guided catheter placement using paramedian-cross view performed by an attending anesthesiologist who is also an investigator After being secured, the thoracic epidural catheter is tested with 3ml lidocaine 2% At 30 minutes after the test dose, the level of sensory block is assessed by using an ice cube to test cold sensation on the skin according to dermatome Epidural analgesia is initiated by a 0.1ml/kg bolus and maintained by continuous infusion of solution 0.1% ropivacaine combined with 1mcg/ml fentanyl during the surgery At the end of the surgery, the patients will paracetamol 15miligram per kilogram and nefopam 20 milligrams, the patient will receive another epidural bolus dose of 0,1ml/kg ropivacaine 0.1% combined with fentanyl 1mcg/ml After the surgery, the patient will receive paracetamol 15miligram per kilogram every 8 hours, nefopam 20mg every eight hours, continuous epidural infusion at rate 4-8 ml per hour, patient-controlled analgesia morphine 1mg bolus, lockout 15 minutes, maximum 4mg per hour. Additional bolus dose of 4ml ropivacaine 0.1% will be administered every 30 min if VAS pain score at rest exceed 4. After two top-up bolus doses of 4ml ropivacaine 0.1% , if VAS pain score at rest still exceed 4, the patient will receive 2mg morphine every 15 minutes until VAS score less than 4 The patient will be monitored for vital signs, pain scores, the level of sensory block, opioids consumption, pain site, other adverse effect of opioids such as respiratory depression, sedation. The patient is also monitored for other signs and symptoms associated with nerve injuries or epidural hematoma such severe back pain, radicular pain, numbness, loss of sensation below the level of epidural catheter placement, paralysis or limb motor weakness.

Conditions

First-attempt Success Rate of Real-time Ultrasound-guided Thoracic Epidural Catheter Placement

Keywords

Real-time ultrasound guided thoracic epidural catheter placement

Outcome Measures

Primary Outcomes (2)

• The first-attempt success rate of real-time ultrasound-guided thoracic epidural catheter placement

  The first-attempt success of thoracic epidural catheter placement is defined as success in achieving a positive loss-of- resistance test and placing the thoracic epidural catheter effortlessly after only one skin puncture

  From skin puncture to successful thoracic epidural catheter placement

• The procedure duration of real-time ultrasound-guided epidural catheter placement

  The time duration from beginning to find ultrasound image of the target structure to successful thoracic epidural catheter placement

  From scanning to identify ultrasound image of the target structure to secure thoracic epidural catheter successfully

Study Arms (1)

real-time ultrasound guided thoracic epidural catheter placement

EXPERIMENTAL

Procedure: Real-time ultrasound-guided thoracic epidural placement

Interventions

Real-time ultrasound-guided thoracic epidural placement PROCEDURE

Real-time ultrasound-guided thoracic epidural catheter placement is performed by an attending anesthesiologist using paramedian-cross view to approach thoracic epidural space. The patient is placed in the prone position with a pillow under the upper abdomen. The probe is placed to identify the rib, then moved medially to identify key anatomical structures: costotransverse joint, transverse process, lamina, superior articular process. The probe is rotated clockwise toward the midline to visualize the lamina and base of the spinal process. A 18G Tuohy needle is advanced under ultrasound guidance from inferior to superior aiming for the interspace between the lamina and base of the upper spinal process. After the tip of Tuohy needle approaches the interspace, the anesthesiologist will perform a loss-of-resistance test to identify the epidural space. Then a catheter will be inserted into epidural space.

real-time ultrasound guided thoracic epidural catheter placement

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are scheduled for major thoracic or abdominal surgeries who have consented to thoracic epidural analgesia

You may not qualify if:

• Patients have contraindications for central neuraxial analgesia, allergic to medications used in the study, unable to cooperate due to cognitive impairment or behavioral limitations, spinal deformities or other spinal pathologies.

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center, Ho Chi Minh City

Ho Chi Minh City, Cho Lon, 749000, Vietnam

RECRUITING

Related Publications (5)

• de Carvalho CC, Porto Genuino W, Vieira Morais MC, de Paiva Oliveira H, Rodrigues AI, El-Boghdadly K. Efficacy and safety of ultrasound-guided versus landmark-guided neuraxial puncture: a systematic review, network meta-analysis and trial sequential analysis of randomized clinical trials. Reg Anesth Pain Med. 2025 Sep 4;50(9):737-746. doi: 10.1136/rapm-2024-105547.

  PMID: 38876801 BACKGROUND

• Kamimura Y, Yamamoto N, Shiroshita A, Miura T, Tsuji T, Someko H, Imai E, Kimura R, Sobue K. Comparative efficacy of ultrasound guidance or conventional anatomical landmarks for neuraxial puncture in adult patients: a systematic review and network meta-analysis. Br J Anaesth. 2024 May;132(5):1097-1111. doi: 10.1016/j.bja.2023.09.006. Epub 2023 Oct 6.

  PMID: 37806932 BACKGROUND

• Deshmukh BY, Shetmahajan MG, Bakshi SG, Jain P. Predicting clinical entry point for thoracic epidural catheter insertion during paramedian approach: A prospective observational study. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):248-252. doi: 10.4103/joacp.joacp_448_22. Epub 2024 Apr 26.

  PMID: 38919420 BACKGROUND

• Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26.

  PMID: 22735301 BACKGROUND

• Sivashanmugam T, Archana A, Nandhini P, Rani P. Real-time ultrasound-guided mid-thoracic epidural access using a novel paramedian cross (PX) view and drip infusion technique: a brief technical report. Reg Anesth Pain Med. 2024 Nov 4;49(11):840-844. doi: 10.1136/rapm-2023-105071.

  PMID: 38388009 BACKGROUND

Study Officials

• PHAN TON NGOC VU, Phd

  The University Medical Center Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TON NU BAO TRAN, Master

CONTACT

+84707702599; tran.tnb@umc.edu.vn

NGOC VU TON PHAN, PhD

CONTACT

+84908883458; vu.ptn@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-05

Locations

VN (1)