Comparing ultrasound-assisted and traditional methods for epidural catheter placement in pregnant patients
Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident
This study is testing if using ultrasound can help doctors place epidural catheters more successfully in pregnant patients compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06811649 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, open-label, single-center study aimed at evaluating the effectiveness of ultrasound-assisted techniques in improving the success rate of epidural catheter placements by resident physicians. The study will compare the echo-assisted loco-regional anesthesia technique with the traditional approach in pregnant patients requiring peridural analgesia. Participants will be randomly assigned to either the intervention or control group, and outcomes will include the success rate of catheter placement and the incidence of complications such as dura puncture. The goal is to determine if ultrasound guidance can enhance the training of residents and improve patient safety.
Who should consider this trial
Good fit: Ideal candidates are pregnant patients over 18 years old who require peridural analgesia and can provide informed consent.
Not a fit: Patients with contraindications to epidural catheter placement, such as severe coagulopathies or endocranial hypertension, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective epidural catheter placements for pregnant patients, reducing complications and improving training for resident anesthesiologists.
How similar studies have performed: Previous studies have shown promising results for ultrasound-assisted techniques in experienced practitioners, but this specific approach for training residents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patients \>18 years of age with no BMI (Body Mass Index) limitation * Pregnant patients requiring partoanalgesia * Obtaining informed consent for study participation Exclusion Criteria: * Patients with contraindications to epidural catheter placement * Endocranial hypertension * Coagulopathies * Severe thrombocytopenia \< 75,000 per mm\^3.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Aurora Guglielmetti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Aurora Guglielmetti, MD
- Email: aurora.guglielmetti@aosp.bo.it
- Phone: 0039 05121414378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.