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Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications (EPİ-TECH)

1 maj 2026 uppdaterad av: dilara gocmen, Marmara University Pendik Training and Research Hospital

Anesthesia Residents' Epidural Catheter Placement Techniques: A Prospective Observational Study on Success Rates and Complications

This prospective observational study aims to evaluate the impact of epidural catheter placement techniques - loss of resistance (LOR) and hanging drop (HD) - on first-attempt success rates and procedural complications among anesthesia residents. Residents with at least two years of training will perform epidural catheterization under supervision for patients scheduled for elective surgery requiring perioperative epidural analgesia. An independent observer will record procedural details, complications, and postoperative pain scores. The study will enroll 440 patients aged 18-80 with ASA I-III classification.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Epidural catheterization is a cornerstone technique in perioperative and obstetric pain management. Two established methods are commonly used to identify the epidural space: the loss of resistance (LOR) technique, using air or normal saline, and the hanging drop (HD) technique. Although both are widely employed, comparative data on their performance by residents in training are limited. This study prospectively observes which technique the resident chooses, records procedural parameters (depth of epidural space, number of attempts, level of insertion), and documents immediate complications (dural puncture, intravascular placement, paresthesia, hypotension) and postoperative outcomes (NRS scores at 0, 6, 12, and 24 hours; PDPH). Cases in which a resident is unable to complete the procedure are documented separately, including the reason for failure and subsequent management by a supervising specialist. All procedures are performed using an 18G Tuohy needle and standard catheter set. A test dose is administered to all patients following catheter placement. Data are recorded by an independent observer using a standardized data collection form.

Studietyp

Observationell

Inskrivning (Beräknad)

440

Kontakter och platser

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Studiekontakt

Studieorter

  • Turkiet (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkiet (Türkiye), 34852
        • Marmara University Pendik Training and Research Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

Adult patients scheduled for elective/emergency surgery with planned perioperative epidural analgesia or anesthesia at Marmara University Pendik Training and Research Hospital, Department of Anesthesiology and Reanimation.

Beskrivning

Inclusion Criteria:

  • Age 18-80 years
  • ASA physical status I, II, or III
  • Scheduled for elective surgery requiring perioperative epidural analgesia or anesthesia (lumbar or thoracic approach)
  • Epidural catheter to be placed by a resident with ≥ 2 years of anesthesia training

Exclusion Criteria:

  • Spinal deformity (scoliosis, kyphosis, or prior spinal surgery at the target level)
  • Coagulopathy or anticoagulant therapy precluding neuraxial blockade
  • Active infection at the insertion site or systemic infection
  • Pre-existing neurological disease affecting the spinal cord or nerve roots
  • Emergency surgery
  • History of prior failed epidural catheterization
  • Patient refusal or inability to provide written informed consent
  • Local anatomical pathology precluding safe epidural access

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Loss of Resistance (LOR) Group
Patients in whom the epidural space is identified using the loss of resistance technique. The attending resident uses a syringe filled with air or normal saline attached to the Tuohy needle hub and advances until resistance disappears upon entering the epidural space.
Procedur: epidural catheter placement
Epidural catheterization performed using an 18G Tuohy needle and standard catheter set by anesthesia residents with a minimum of two years of training, under specialist supervision. Technique selection (LOR or HD) is at the discretion of the performing resident and is not randomized.
Andra namn:
  • neuroaxial blockade
Hanging Drop (HD) Group
Patients in whom the epidural space is identified using the hanging drop technique. A drop of normal saline is placed at the Tuohy needle hub and observed to be aspirated inward by the negative epidural pressure as the needle tip traverses the ligamentum flavum.
Procedur: epidural catheter placement
Epidural catheterization performed using an 18G Tuohy needle and standard catheter set by anesthesia residents with a minimum of two years of training, under specialist supervision. Technique selection (LOR or HD) is at the discretion of the performing resident and is not randomized.
Andra namn:
  • neuroaxial blockade

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
First-attempt success rate
Tidsram: Time Frame: Immediately upon procedure completion
Defined as successful epidural space identification and catheter placement in a single Tuohy needle insertion attempt, without redirecting the needle.
Time Frame: Immediately upon procedure completion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dural puncture rate
Tidsram: Intraoperative
Inadvertent dural puncture defined as free flow of cerebrospinal fluid through the Tuohy needle or epidural catheter, confirmed by visual inspection. Recorded as yes/no by the independent observer at the time of the procedure
Intraoperative
Catheter Advancement Failure Rate
Tidsram: intraoperative
Inability to thread the epidural catheter beyond 3 cm into the epidural space despite confirmed needle placement, necessitating needle repositioning or procedure abandonment. Recorded as yes/no by the independent observer.
intraoperative
Operator-Assessed Difficulty Score
Tidsram: Immediately after procedure completion
The performing resident rates the overall technical difficulty of the procedure immediately upon completion using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, 5 = very difficult. Recorded on the standardized data collection form
Immediately after procedure completion
Intravascular catheter placement rate
Tidsram: intraoperative
Unintentional intravascular placement defined as aspiration of blood through the epidural catheter prior to test dose administration. Recorded as yes/no by the independent observer immediately following catheter advancement
intraoperative
Postoperative Pain Scores
Tidsram: 0, 6, 12, and 24 hours postoperatively
Pain intensity assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Recorded at four time points: immediately upon arrival to the recovery unit (0 hours), and at 6, 12, and 24 hours postoperatively by the independent observer.
0, 6, 12, and 24 hours postoperatively
Rate and Type of Assistance Required During Catheter Placement
Tidsram: Intraoperative
The level of assistance received by the performing resident is recorded in three categories: (1) No assistance - procedure completed independently; (2) Verbal guidance only - supervising specialist provides verbal instructions without physical intervention; (3) Physical assistance - supervising specialist takes over needle or catheter manipulation partially or completely. Recorded by the independent observer at the time of the procedure.
Intraoperative
First-Attempt Success Rate Stratified by Resident Seniority Level
Tidsram: Intraoperative
First-attempt success rates are compared across three seniority strata defined by duration of anesthesia training: junior residents (2-3 years), intermediate residents (3-4 years), and senior residents (4 years and above). Seniority is determined by the total duration of anesthesia specialty training at the time of the procedure.
Intraoperative

Samarbetspartners och utredare

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Sponsor

Marmara University Pendik Training and Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 1. Hoffmann VL, Vercauteren MP, Vreugde JP, Hans GH, Coppejans HC, Adriaensen HA. Posterior epidural space depth: safety of the loss of resistance and hanging drop techniques. British Journal of Anaesthesia. 1999;83(5):807-811. 2. Günaydın B, Tan A, Doğru O, Mutlu M, Öztürk G, Güler HG. Comparison of spring-loaded, loss of resistance and hanging drop techniques in lumbar epidural blocks. Agri. 2012;24(1):13-18. 3. Azizov S, Okcu M, Goksu H. Could the Hanging Drop Technique Be an Alternative Method to Loss of Resistance in Cervical Epidural Injections? Pain Physician. 2025;28:217-221. 4. Tran DQH, González AP, Bernucci F, Finlayson RJ. Confirmation of Loss-of-Resistance for Epidural Analgesia. Regional Anesthesia and Pain Medicine. 2015;40(2):166-173. 5. Yoshida K, Tanaka S, Watanabe K. Hanging-Drop Technique Is More Suitable for Epidural Space Confirmation in Patients With Subcutaneous Emphysema After Traumatic Multiple Rib Fractures. Journal of Cardiothoracic and Vascular Anesthesia. 2023;37(12). 6. Konrad C, Schüpfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesthesia & Analgesia. 1998;86(3):635-639. 7. De Oliveira GS, Glassenberg R, Chang R, Fitzgerald P, McCarthy R. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013;68(10):1053-1058. 8. Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia learning curve. Regional Anesthesia. 1996;21(3):182-190. 9. Naik VN, Devito I, Halpern SH. Cusum analysis is a useful tool to assess resident proficiency at epidural anesthesia. Canadian Journal of Anesthesia. 2004;51(7):703-708.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 maj 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

1 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 maj 2026

Första postat (Faktisk)

7 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • mü anesthesia

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