Evaluation of the Typical Spinal Block During Cesarean Delivery

NCT06206044 | Enrolling By Invitation FDA Drug

• 1 other identifier: 25364
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Anesthesia, Obstetric

Keywords

Spinal anesthesia; bupivacaine; Sensory dermatomal level

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine

Interventions

Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine DRUG

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.

Also known as: Marcaine

Study Cohort

Eligibility Criteria

• Age: 15 Years - 55 Years
• Gender Eligibility Details: Participants must be biologically female, this study evaluates spinal anesthesia given to pregnant individuals undergoing cesarean section delivery
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (7)

• 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.

  PMID: 18547291 BACKGROUND

• 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.

  PMID: 15321392 BACKGROUND

• 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.

  PMID: 23061397 BACKGROUND

• 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.

  PMID: 25388969 BACKGROUND

• 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.

  PMID: 15636981 BACKGROUND

• 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.

  PMID: 35289377 BACKGROUND

• 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.

  PMID: 16256334 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)