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The goal of this clinical trial is to learn if finding and marking the best spot on the back early in labor helps doctors perform epidural pain relief more successfully in pregnant women. Usually, epidural pain relief is requested when labor pain is already severe, which makes it hard for women to hold still. This makes it difficult to find the right needle spot, leading to more needle attempts
The main questions this study aims to answer are:
Participants will, if consented and participated in the study:
Background: Epidural analgesia is a widely accepted and highly effective method for managing labor pain. Traditionally, anesthesiologists identify the epidural insertion site by manually palpating anatomical landmarks. However, this conventional approach can be challenging and imprecise for many parturients. Factors such as soft tissue edema, exaggerated lumbar curvature during pregnancy, and rising obesity rates can obscure bony landmarks. Furthermore, frequent and painful uterine contractions during active labor often hinder the patient from maintaining the ideal flexed posture required for the procedure. These clinical challenges can result in multiple needle insertions, frequent redirection, prolonged procedure times, and an increased risk of patient discomfort or procedural complications.
Preprocedural spinal ultrasound has emerged as a valuable tool to address these limitations. By visualizing the anatomy in advance, clinicians can accurately identify the appropriate intervertebral space, locate the mid line, determine the optimal needle insertion point and angle, and measure the precise distance from the skin to the epidural space. While prior research indicates that ultrasound guidance reduces technical difficulty, minimizes needle passes, and enhances first-attempt success rates, many of these studies lacked rigorous blinding or involved the same clinician performing both the ultrasound and the epidural placement, introducing potential observer bias. Additionally, in Vietnam, there is a lack of high-quality interventional research comparing ultrasound-assisted and traditional palpation techniques using standardized outcome measures.
Therefore, this randomized, double-blind clinical trial aims to evaluate the efficacy of ultrasound-assisted marking versus conventional palpation for labor epidural analgesia. We hypothesize that preprocedural spinal ultrasound guidance significantly improves the first-attempt success rate without requiring needle redirection when compared to the traditional technique. The results of this study aim to optimize clinical practice by promoting routine use of preprocedural ultrasound to enhance safety, efficacy and the overall childbirth experience. A key feature of this study is performing ultrasound assessment early in labor, prior to the onset of severe pain or a request for analgesia. This timing allows the parturient to remain comfortable, alert, and highly cooperative, ensuring precise marking. Once active labor necessitates epidural analgesia, the attending physician anesthesiologist can rely on the pre-marked site, streamlining the procedure and reducing patient wait times and distress Study Objectives: The objective of this study is to evaluate the effectiveness of neuraxial ultrasound compared with the conventional anatomical landmark palpation technique for epidural analgesia during labor.
Study Design and Methodology: This is a randomized, double-blind, controlled clinical trial conducted at the Obstetrics Department of the University Medical Center Ho Chi Minh City. Parturients are randomly assigned (in a 1:1 ratio using block randomization) to either the Ultrasound Group or the Landmark Group.
4. Detailed Intervention Workflow: The study protocol is distinctly divided into two phases managed by different personnel to ensure strict blinding:
Phase 1 - Preprocedural Assessment and Marking (Labor Waiting Room): Parturients are positioned on the lateral decubitus position (knees flexed to the abdomen, neck flexed) to maximize the opening of the intervertebral spaces. The first investigator (an anesthesiologist experienced in neuraxial ultrasound) opens the sealed randomization envelope and performs the assessment:
Phase 2: Epidural Placement (Delivery Room) Once marked, the parturient is transferred to the delivery room for the epidural procedure.
Data Collection: All procedural data, timings, and clinical outcomes are meticulously recorded by an independent anesthetic nurse present in the delivery room, who is also completely blinded to the randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound group | Experimental | Participants in this arm will undergo preprocedural spinal ultrasound while on the left lateral decubitus position. The ultrasound is used to identify the L3-L4 interspace, the midline, and the optimal needle insertion point. |
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| Landmark Group | Active Comparator | Participants in this arm will undergo manual palpation of surface bony landmarks of L3-L4 interspace while on the left lateral decubitus position. This conventional approach determines the needle insertion point without relying on ultrasound guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preprocedural Spinal Ultrasound | Procedure | A curvilinear probe is applied to the lower back in a transverse orientation. The vertebral midline is marked after identifying a symmetrical image in the transverse spinous process view. The probe is then oriented to obtain a paramedian sagittal laminar view. After locating the sacrum and lumbosacral junction, the probe is moved cephalad to identify and mark the L3 and L4 laminae. The probe is rotated back to a transverse view to systematically assess the lumbar interlaminar spaces, using the posterior complex (ligamentum flavum, epidural space, and posterior dura) and the anterior complex (anterior dura, posterior longitudinal ligament, and posterior vertebral body) as key landmarks. Markings are done with pen at four midpoints of the probe's edges in the L3-L4 space with the largest acoustic window. The intersection of horizontal and vertical lines drawn from these marks designates the needle insertion point. |
| Measure | Description | Time Frame |
|---|---|---|
| First-pass success | Yes/No variable. First-pass success is defined as the successful identification of the epidural space during the initial forward advancement of the needle, without any needle redirection or withdrawal | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| First-attempt success | Yes/No variable. First-attempt success is defined as the successful identification of the epidural space achieved with only a single skin puncture | Periprocedural |
| Number of needle redirections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| An Vu Nguyen, MD, MSc | Contact | +84826027842 | 6447 | an.nv1@umc.edu.vn |
| Phong Quang Le, MD, MSc | Contact | +84972789631 | phong.lq@umc.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| An Vu Nguyen, MD, MSc | University Medical Center Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ho Chi Minh City | Recruiting | Ho Chi Minh City | Ho Chi Minh | 700000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30234528 | Background | Li M, Ni X, Xu Z, Shen F, Song Y, Li Q, Liu Z. Ultrasound-Assisted Technology Versus the Conventional Landmark Location Method in Spinal Anesthesia for Cesarean Delivery in Obese Parturients: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):155-161. doi: 10.1213/ANE.0000000000003795. | |
| 31213044 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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To protect the privacy and confidentiality of the participants in accordance with institutional and national guidelines
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel Assignment
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| Conventional Landmark Palpation | Procedure | The anesthesiologist manually palpates anatomical landmarks to identify L3-L4 interspace and marks the midline insertion site. An ultrasound probe is then placed over this marked site only to measure skin-to-epidural depth for data collection purposes. These measurements are recorded but are not used to adjust or alter the marked insertion point. |
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A needle redirection is defined as any partial withdrawal of the needle followed by a change in its advancement angle without the needle tip exiting the skin surface.
| Periprocedural |
| Number of needle attempts | A needle attempt is defined as a new skin puncture after the needle has been completely withdrawn. | Periprocedural |
| Procedure time | Measured in seconds. Time from the moment the proceduralist inserts the Touhy needle at the marked position to final catheter fixation. | Periprocedural |
| Paresthesia | Yes/No variable. Paresthesia is defined as any abnormal sensation (electric shock-like, tingling, or numbness) reported by the patient during needle insertion or catheter insertion. | Periprocedural |
| Vascular puncture | Yes/No variable. Vascular puncture is defined as the presence of blood in the catheter or flashback in the needle. | Periprocedural |
| Dural puncture | Yes/No variable. Presence of cerebrospinal fluid (CSF) in the Tuohy needle or upon catheter aspiration | Periprocedural |
| Adequate analgesia | Yes/No variable. VAS less than 3 at one hour post procedurally. | 1 hour post-procedure |
| Maternal satisfaction | Patient satisfaction of the procedure is measured on a 0-10 Visual Analog Scale (VAS), where 0 represented 'completely dissatisfied' and 10 represented 'completely satisfied'. | 2 hours postpartum |
| Procedure failure | Yes/No variable. Procedure failure is defined as inability to identify the epidural space after attempting at three different skin puncture sites | Periprocedural |
| Change of intervertebral space | Yes/No variable. A change of intervertebral space is defined as the complete withdrawal of the needle from the initially selected spinal level and re-insertion at a different level. | Periprocedural |
| Tubinis MD, Lester SA, Schlitz CN, Morgan CJ, Sakawi Y, Powell MF. Utility of ultrasonography in identification of midline and epidural placement in severely obese parturients. Minerva Anestesiol. 2019 Oct;85(10):1089-1096. doi: 10.23736/S0375-9393.19.13617-6. Epub 2019 Jun 17. |
| 34050798 | Background | Ni X, Li MZ, Zhou SQ, Xu ZD, Zhang YQ, Yu YB, Su J, Zhang LM, Liu ZQ. Accuro ultrasound-based system with computer-aided image interpretation compared to traditional palpation technique for neuraxial anesthesia placement in obese parturients undergoing cesarean delivery: a randomized controlled trial. J Anesth. 2021 Aug;35(4):475-482. doi: 10.1007/s00540-021-02922-y. Epub 2021 May 29. |
| 38876801 | Background | 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. |
| 27701372 | Background | Perna P, Gioia A, Ragazzi R, Volta CA, Innamorato M. Can pre-procedure neuroaxial ultrasound improve the identification of the potential epidural space when compared with anatomical landmarks? A prospective randomized study. Minerva Anestesiol. 2017 Jan;83(1):41-49. doi: 10.23736/S0375-9393.16.11399-9. Epub 2016 Oct 4. |
| 28235536 | Background | Ekinci M, Alici HA, Ahiskalioglu A, Ince I, Aksoy M, Celik EC, Dostbil A, Celik M, Baysal PK, Golboyu BE, Yeksan AN. The use of ultrasound in planned cesarean delivery under spinal anesthesia for patients having nonprominent anatomic landmarks. J Clin Anesth. 2017 Feb;37:82-85. doi: 10.1016/j.jclinane.2016.10.014. Epub 2017 Jan 4. |
| 38155223 | Background | Bae J, Kim Y, Yoo S, Kim JT, Park SK. Handheld ultrasound-assisted versus palpation-guided combined spinal-epidural for labor analgesia: a randomized controlled trial. Sci Rep. 2023 Dec 27;13(1):23009. doi: 10.1038/s41598-023-50407-7. |
| 12031746 | Background | Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6. |
| 25036283 | Background | Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119. |
| 11172514 | Background | Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available. |
| 29322504 | Background | Chin A, Crooke B, Heywood L, Brijball R, Pelecanos AM, Abeypala W. A randomised controlled trial comparing needle movements during combined spinal-epidural anaesthesia with and without ultrasound assistance. Anaesthesia. 2018 Apr;73(4):466-473. doi: 10.1111/anae.14206. Epub 2018 Jan 10. |
| 27183373 | Background | Tawfik MM, Atallah MM, Elkharboutly WS, Allakkany NS, Abdelkhalek M. Does Preprocedural Ultrasound Increase the First-Pass Success Rate of Epidural Catheterization Before Cesarean Delivery? A Randomized Controlled Trial. Anesth Analg. 2017 Mar;124(3):851-856. doi: 10.1213/ANE.0000000000001325. |
| 32981051 | Background | Young B, Onwochei D, Desai N. Conventional landmark palpation vs. preprocedural ultrasound for neuraxial analgesia and anaesthesia in obstetrics - a systematic review and meta-analysis with trial sequential analyses. Anaesthesia. 2021 Jun;76(6):818-831. doi: 10.1111/anae.15255. Epub 2020 Sep 27. |