NCT06206044|Enrolling By InvitationFDA Drug
Evaluation of the Typical Spinal Block During Cesarean Delivery
Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
Loading search results
Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
Sponsor study identifier
observational
250
1 country
1
Study Start
June 10, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This will be a prospective, observational, single-center study to evaluate the accuracy of sensory testing by blunt 16-gauge plastic cannula during the 15 minutes after spinal injection for predicting spinal failure. While previous studies assessed the minimal sensory level required for painless cesarean delivery at skin incision or delivery, no studies have assessed the accuracy of sensory testing at an earlier time point.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2024
Actual (reported)January 16, 2024
Actual (reported)June 10, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of participants with spinal failure
A composite outcome that will be categorized as "yes" if there is either preoperative or intraoperative spinal failure. Preoperative failure will be defined as failure to achieve a T4 level to pinprick by the 15-minute timepoint. Intraoperative failure will be defined as pain (VAS \> 0) that requires anesthesia provider medication administration. Pain will be queried at time of skin incision, fetal delivery, uterine exteriorization, uterine interiorization or end of uterine closure, and end of skin closure. If VAS \> 0, the anesthesia provider will ask the patient if they would like analgesic medication. Discomfort at any other time during the cesarean delivery that is treated with neuraxial or intravenous analgesia will also count. Pain will be rated according to the scale: 0 = no pain, 10 = worst pain imaginable
90 minutes
Number of participants with conversion to another anesthetic technique
90 minutes
Number of participants with inadequate anesthesia
90 minutes
Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction
2 Hours
Healthy pregnant women of BMI between 20 and 40 kg/m2, height between 5 feet 2 inches and 5 feet 10 inches, who are having cesarean delivery under spinal or combined spinal epidural anesthesia.
Patients will receive standard intrathecal medications for urgent and scheduled cesarean delivery at the study site. All study subjects will receive bupivacaine, fentanyl, and morphine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery
Oregon Health and Science University
Portland, Oregon, 97239, United States
Kinsella SM. A prospective audit of regional anaesthesia failure in 5080 Caesarean sections. Anaesthesia. 2008 Aug;63(8):822-32. doi: 10.1111/j.1365-2044.2008.05499.x. Epub 2008 Jun 28.
Russell IF. A comparison of cold, pinprick and touch for assessing the level of spinal block at caesarean section. Int J Obstet Anesth. 2004 Jul;13(3):146-52. doi: 10.1016/j.ijoa.2003.12.007.
Ousley R, Egan C, Dowling K, Cyna AM. Assessment of block height for satisfactory spinal anaesthesia for caesarean section. Anaesthesia. 2012 Dec;67(12):1356-63. doi: 10.1111/anae.12034. Epub 2012 Oct 12.
Brandon M Togioka, MD
Oregon Health and Science University
First Submitted
January 4, 2024
First Posted
January 16, 2024
Study Start
June 10, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
Hoyle J, Yentis SM. Assessing the height of block for caesarean section over the past three decades: trends from the literature. Anaesthesia. 2015 Apr;70(4):421-8. doi: 10.1111/anae.12927. Epub 2014 Nov 10.
Russell IF. Levels of anaesthesia and intraoperative pain at caesarean section under regional block. Int J Obstet Anesth. 1995 Apr;4(2):71-7. doi: 10.1016/0959-289x(95)82995-m.
de Souza Soares EC, Balki M, Downey K, Ye XY, Carvalho JCA. Assessment of sensory block during labour epidural analgesia: a prospective cohort study to determine the influence of the direction of testing. Can J Anaesth. 2022 Jun;69(6):750-755. doi: 10.1007/s12630-022-02228-x. Epub 2022 Mar 14.
Yentis SM. Height of confusion: assessing regional blocks before caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):2-6. doi: 10.1016/j.ijoa.2005.06.010. Epub 2005 Oct 26. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 20, 2024
Record last verified: 2024-11
Due to patient data protection regulations within the study site there is not a plan to make individual participant data available to other researchers. Reasonable requests emailed to the PI will considered on a case-by-case basis.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: