Evaluation of the Typical Spinal Block During Cesarean Delivery
NCT ID: NCT06206044
Last Updated: 2024-11-20
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
250 participants
OBSERVATIONAL
2024-06-10
2026-01-31
Brief Summary
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Detailed Description
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1\. Evaluate the accuracy of sensory testing with blunt plastic 16-gauge cannula during the 15 minutes after spinal injection for predicting spinal failure. Cephalad sensory dermatomal levels will be assessed at 1 (t1), 3 (t3), 5 (t5), 7 (t7), 9 (t9), 11 (t11), 13 (t13), and 15 (t15) minutes after intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg morphine (study solution). Spinal failure, which is defined as inability to achieve a T4 level to pinprick by the 15-minute timepoint or intraoperative pain (VAS \> 0) requiring treatment
Secondary Objectives:
1. Conversion to another anesthetic technique (general anesthesia or activation of the epidural catheter)
2. Inadequate anesthesia (analgesic supplementation with ketamine, \> 20 mg propofol, \> 2 mg midazolam, \> 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine).
3. Patient satisfaction upon arrival to the postanesthesia care unit, rated on a 1-5 Likert scale
A sample size calculation
Population: 250 pregnant females undergoing non-emergency cesarean section delivery in the Labor \& Delivery Operating Rooms at Oregon Health \& Science University.
Number of Sites: Single center trial
Study Duration: Institutional Review Board approval has been obtained. Study initiation, enrollment, and data collection is expected to take 24 months. Data analysis, manuscript writing, editing, submission and revision to a peer-reviewed journal is expected to take an additional 6 months.
In summary, the study should be completed in under 3 years.
Subject Participation Duration: Total time of subject participation including time for recruitment, enrollment, data collection during the preanesthesia consult, and post-consult data collection will be less than 3 hours.
Estimated Time to Complete Enrollment: Estimated time from enrollment into study of the first subject to enrollment into study of the last subject is 24 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Cohort
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.
Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
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.
Interventions
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Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 20 and 40 kg/m2
* Height between 5 feet 2 inches and 5 feet 10 inches.
* English and non-English speaking patients, if interpretive services are available
Exclusion Criteria
* Contraindications to neuraxial anesthesia (coagulopathy, CNS pathology, infection at site of needle puncture)
* Allergy to any study medications
* Use of epidural anesthesia
* Emergency (red) cesarean delivery
* Conditions that impact dermatomal sensory testing including spinal cord injury with sensory deficits and abdominoplasty
* Prison inmates
* Decisionally impaired individuals
* Pregnancies involving multiple fetuses
15 Years
55 Years
FEMALE
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Brandon M Togioka
Principal Investigator
Principal Investigators
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Brandon M Togioka, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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25364
Identifier Type: -
Identifier Source: org_study_id
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