Clinical trial NCT06206044: Evaluation of the Typical Spinal Block During Cesarean Delivery
Official title: Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cesarean Section
Anesthesia, Obstetric
Keywords: Spinal anesthesia
bupivacaine
Sensory dermatomal level
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery

Brief summary: 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.

Detailed description: Primary Objective:

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cesarean delivery under spinal or combined spinal epidural anesthesia
* 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:

* Patient refusal
* 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

Primary outcomes:
measure: Number of participants with spinal failure
timeFrame: 90 minutes
Secondary outcomes:
measure: Number of participants with conversion to another anesthetic technique
timeFrame: 90 minutes
measure: Number of participants with inadequate anesthesia
timeFrame: 90 minutes
measure: Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Brandon M Togioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.