Lumbar Ultrasound Clinical Trial
Official title:
Pre-insertion Ultrasound Guidance for Labor Epidural Placement in the Lateral Position: A Randomized Controlled Trial of Image Reproducibility During Labor and Impact on Resident Learning Curve
NCT number | NCT02826668 |
Other study ID # | 2013P002510 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | August 1, 2021 |
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Pregnant Subjects Inclusion Criteria: - pregnant women - 18 years or older - in early labor (cervix dilated < 5 cm - pain visual analog score (VAS) < 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief. Exclusion Criteria: - absolute contraindications of neuraxial anesthesia including patient refusal - uncorrected coagulopathy - infection at the skin site of epidural placement - increased intracranial pressure, or untreated hemodynamic instability. - In addition, patients with a history of scoliosis or spine surgery - body mass index (BMI) >40 kg/m2 - allergy to local anesthetic, or allergy to opioids will be excluded. Anesthesiologists Inclusion criteria: - Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study. - Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment. Exclusion criteria: - individuals who do not want to participate in the study. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
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Brigham and Women's Hospital |
United States,
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
Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007. Review. — View Citation
Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. — View Citation
Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. — View Citation
Harney D, Moran CA, Whitty R, Harte S, Geary M, Gardiner J. Influence of posture on the incidence of vein cannulation during epidural catheter placement. Eur J Anaesthesiol. 2005 Feb;22(2):103-6. — View Citation
Mhyre JM, Greenfield ML, Tsen LC, Polley LS. A systematic review of randomized controlled trials that evaluate strategies to avoid epidural vein cannulation during obstetric epidural catheter placement. Anesth Analg. 2009 Apr;108(4):1232-42. doi: 10.1213/ane.0b013e318198f85e. Review. — View Citation
Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20. — View Citation
Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound. | Measured depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline, at level L3-4. | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Time required for epidural placement | Time required for placement (T0 = insertion of needle for subcutaneous lidocaine infusion prior to epidural needle placement). Tfinal = time at complete removal of Weiss epidural needle after catheter is threaded into the epidural space. | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Need for assistance from additional anesthesiologist | Need for assistance from additional anesthesiologist | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Number of attempts at epidural placement | defined as number of times the Weiss epidural needle enters the skin | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Incidence of paresthesias | Paresthesia defined as pain with needle or catheter insertion | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Labor pain at time of 30 minutes after placement is complete. | Labor pain rated on a visual analog scale (VAS) | From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes. | |
Primary | Rate of epidural replacement for inadequate analgesia | Inadequate analgesia determined as VAS >3 despite catheter adjustment and/or epidural dose adjustment. | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Rate of inadvertent dural puncture at the time of placement. | Defined as cerebrospinal fluid aspiration through needle or catheter. | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | Midline measurement from baseline ultrasound compared to pre-placement ultrasound. | Measured midline (anatomical marking) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline. | From enrollment to time of epidural placement, approximately 5 hours | |
Primary | L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound. | Measured L3-L4 lumbar spine level from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, paramedic. | From enrollment to time of epidural placement, approximately 5 hours |
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