Evaluation of the Typical Spinal Block During Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06206044
• Other study ID #: 25364
• Status: Enrolling by invitation
• Start date: June 10, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 Hours
Secondary	Number of participants with conversion to another anesthetic technique	Conversion to general anesthesia or activation of the epidural catheter	2 Hours
Secondary	Number of participants with inadequate anesthesia	Analgesic supplementation with ketamine, > 20 mg propofol, > 2 mg midazolam, > 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine	2 Hours
Secondary	Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction	Patient satisfaction upon arrival to the post-anesthesia care unit, rated on a 1-5 Likert scale with higher values representing better patient satisfaction	2 Hours