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First-attempt Success Rate of Real-time Ultrasound-guided Thoracic Epidural Catheter PlacementNCT07100769

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

A study testing Real-time ultrasound-guided thoracic epidural placement in people with First-attempt Success Rate of Real-time Ultrasound-guided Thoracic Epidural Catheter Placement, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Real-time ultrasound-guided thoracic epidural placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteVietnam
Study dates
23 May 2025to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

TON NU BAO TRAN, Master contact

+84707702599

tran.tnb@umc.edu.vn

NGOC VU TON PHAN, PhD contact

+84908883458

vu.ptn@umc.edu.vn

Vietnam1 site, 1 recruiting
  • University Medical Center, Ho Chi Minh City

    Ho Chi Minh City, Cho Lon, 749000

    BAO TRAN NU TON, Master, 84707702599, tran.tnb@umc.edu.vn

    NGOC VU TON PHAN, PhD, +840908883458

    Recruiting

Other trials in Vietnam

About this study

Official title: Application of Real-time Ultrasound-guidance in Thoracic Epidural Catheter Placement on Patients Undergoing Major Abdominal Thoracic or Abdominal Surgeries

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.

Read the detailed description

The consecutive sampling method is used in this clinical trial. Patients who meet inclusion criteria and consent to participate will be recruited Real-time ultrasound-guided epidural placement is performed by an attending anesthesiologists on participants using a paramedian-cross view to approach to the thoracic epidural space.

The process of real-time ultrasound-guided epidural catheter placement is described in detail in the following procedure.

Patient is placed in the prone position with continuous monitoring and oxygen supplementation via nasal cannula. A thin pillow is placed under the upper abdomen. After establishing an adequately sterilized field , the anesthesiologist places curvilinear probe on the 12th rib, then move cranially, until the rib below the target interlaminar space is reached. Then, probe is slid medially to identify anatomical structures: costotransverse joint, transverse process, lamina, superior articular process. Once consecutive laminas and superior articular processes are identified, the probe is the rotated clockwise toward the midline to visualize key ultrasound images from caudal to cranial positions: the lower transverse process, the lamina, the targeted interspace between the lower lamina and base of the upper spinal process. Then, 2ml of 1% lidocaine is administered to numb the anticipated skin puncture site. After that, 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. Since the tip of Tuohy needle reaches the interspace between the lamina and base of the upper spinal process, the anesthesiologist performs a loss-of-resistance test using 0.9% saline to identify the thoracic epidural space. After achieving positive loss-of- resistance test, a catheter is advanced 4-5 cm into the epidural space. Finally, a test dose of 3 ml of 2% lidocaine is administered via the catheter.

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. The evaluation will be conducted by an anesthesiologist or an anesthesia nurse. The cold sensation in the thoracic-abdominal dermatomes will be compared to the cold sensation in the shoulder or the ipsilateral arm and any reduction in cold perception in the tested dermatomes will be documented.

After having thoracic epidural catheter placement, the patient undergoes general anesthesia with routine monitoring. Intraoperative management is conducted by another attending anesthesiologist who doesn't participate in the study. After general anesthesia induction and patient positioning, the epidural catheter is activated with a bolus dose of 0.1 ml per kilogram solution of 0.1% ropivacaine + fentanyl 2mcg/ml. Vital signs are monitored every 5 minutes following epidural activation and for 15 minutes after surgical incision.

During the surgery, general anesthesia is maintained with sevoflurane or desflurane at MAC 1-1.2, along with continuous neuromuscular agent infusion to achieve TOF 0-1.The solution containing 0.1% ropivacaine and fentanyl 2mcg/ml at rate 4-8ml per hour is infused continuously via the epidural catheter. An additional intravenous bolus dose of fentanyl 1mcg/kg is administered if heart rate and blood pressure exceed 20% of baseline levels.

Before the completion of surgery, multimodal analgesia is initiated with intravenous paracetamol (15mg/kg) and nefopam (20mg). Additionally, a bolus dose of 0.1ml/kg of local anesthetic solution 0.1% ropivacaine combined with 2mcg/ml fentanyl is administered via the epidural catheter for postoperative pain control.

After surgery, patients will receive multimodal analgesia, including intravenous paracetamol 15 milligrams per kilogram and nefopam 20 milligrams every 8 hours. Epidural analgesia is maintained with a continuous infusion of 0.1% ropivacaine at a rate of 4-8 ml per hour, along with patient-controlled analgesia (PCA) morphine bolus dose of 1 milligram, with a 15-minute lockout interval and a maximum dose of 4 mg per hour.

Patients are monitored for vital signs, level of sensory blockade, pain scores using the Visual Analog Scale (VAS) at rest and during coughing, reported pain location, opioid consumption at specific time points 2, 8, 16, 24, and 48 hours postoperatively. If VAS pain scores at rest exceed 4, a top-up bolus of 4ml of 0.1% ropivacaine is administered via the epidural catheter. Vital signs, pain scores and the level of sensory block are monitored every 15 minutes following the rescue dose. A second 4ml 0.1% ropivacaine bolus can be administered 30 minutes after the first bolus. 30 minutes after the second, if the VAS score at rest still exceeds 4, a rescue 2mg morphine bolus every 15 minutes is administered until the VAS score is less than 4.

The epidural catheter is removed 48 hours after the surgery, provided there are no signs of severe back pain , neurological deficits, hypotension associated with epidural infusion, catheter dislodgement.

Being tested
Real-time ultrasound-guided thoracic epidural placement
Keywords
Real-time ultrasound guided thoracic epidural catheter placement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real-time ultrasound-guided thoracic epidural placementProcedure or surgery

    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.

Study groups in NCT07100769
Study groupRoleWhat they receive
real-time ultrasound guided thoracic epidural catheter placementExperimentalNot described
Receives: Procedure: Real-time ultrasound-guided thoracic epidural placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From skin puncture to successful thoracic epidural catheter placement

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start23 May 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07100769
Sponsor's protocol ID
23/2025/HĐ-ĐHYD
Status last verified
May 2025
First submitted
27 Jul 2025
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38876801
  • 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.

    PubMed 37806932
  • 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.

    PubMed 38919420
  • 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.

    PubMed 22735301
  • 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.

    PubMed 38388009

Questions about this trial

What is this clinical trial studying?

A study testing Real-time ultrasound-guided thoracic epidural placement in people with First-attempt Success Rate of Real-time Ultrasound-guided Thoracic Epidural Catheter Placement, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TON NU BAO TRAN, Master (+84707702599, tran.tnb@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The first-attempt success rate of real-time ultrasound-guided thoracic epidural catheter placement (time frame: From skin puncture to successful thoracic epidural catheter placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100769, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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