Epidural; Anesthesia Clinical Trial
Official title:
Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial
Verified date | March 2019 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.
Status | Completed |
Enrollment | 56 |
Est. completion date | February 28, 2020 |
Est. primary completion date | April 8, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Full-term parturients (= 37 weeks of amenorrhea) - With pre-pregnancy BMI = 30 kg/m2 - Admit for a vaginal delivery - Receiving labour epidural analgesia Exclusion Criteria: - Usual contraindications for neuraxial anesthesia (thrombocytopenia, coagulopathy, uncorrected hypovolemia, infected puncture site, intracranial hypertension) - Emergency maternal and foetal cases - Twin pregnancy - Marked spinal deformity ou previous spinal surgery - Refusal to participate |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Cote de Nacre | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of the epidural space identification at the first needle pass | Succes rate of the epidural space identification at the first needle pass (first skin puncture and without needle redirection) for each group | Baseline up to 1 hour | |
Secondary | Success of the epidural space identification at the first skin puncture | Success rate of the epidural space identification at the first needle pass (first skin puncture with at least one redirection) for each group | Baseline up to 1 hour | |
Secondary | Number of skin punctures | Number of skin punctures per parturient | Baseline up to 1 hour | |
Secondary | Number of needle redirections | Number of needle redirections per parturient | Baseline up to 1 hour | |
Secondary | Number of intervertebral space punctured | Number of intervertebral space punctured per parturient | Baseline up to 1 hour | |
Secondary | Duration of the epidural procedure | Duration of the epidural procedure in seconds, measured from the first skin puncture to the test dose | Baseline up to 1 hour | |
Secondary | Early Failed of the epidural analgesia | Early Failed epidural analgesia, defined by the epidural analgesia remplacement within 30 minutes | 30 minutes after the end of the procedure | |
Secondary | Verbal Rating Scale | Verbal Rating Scale (VRS) of pain measured after the epidural procedure : from 0 (no itch) to 10 (worst imaginable itch) | 30 minutes and 120 minutes after the epidural procedure | |
Secondary | Accidental Dural puncture | Occurence of accidental dural puncture during the epidural procedure | Baseline up to 1 hour | |
Secondary | Post dural puncture headache | Occurence of Post dural puncture headache after the epidural procedure | 48 hours after the epidural procedure | |
Secondary | Quality of epidural analgesia | Maternal perception of epidural analgesia quality during the labour : from 1 (very bad) to 5 (excellent) | 48 hours after the epidural procedure | |
Secondary | Maternal perception of the duration of the epidural procedure | Maternal perception of epidural procedure duration : from 1(very short) to 5 (very long) | 48 hours after the epidural procedure |
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