Cesarean SectionNCT06206044
Evaluation of the Typical Spinal Block During Cesarean Delivery
An observational study of Cesarean Section and Anesthesia, Obstetric, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women only
- Conditions the study is for
- Cesarean Section, Anesthesia, Obstetric
- What is being tested?
- Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prison inmates
- Decisionally impaired individuals
- Pregnancies involving multiple fetuses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
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.
Read the detailed description
Primary Objective:
- 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:
- Conversion to another anesthetic technique (general anesthesia or activation of the epidural catheter)
- Inadequate anesthesia (analgesic supplementation with ketamine, > 20 mg propofol, > 2 mg midazolam, > 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine).
- 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
- Cesarean Section, Anesthesia, Obstetric
- Being tested
- Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
- Keywords
- Spinal anesthesia, bupivacaine, Sensory dermatomal level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphineDrug
Also called Marcaine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes
Secondary outcomes (3)
Number of participants with conversion to another anesthetic technique
Conversion to general anesthesia or activation of the epidural catheter for intraoperative pain
Measured: 90 minutes
Number of participants with inadequate anesthesia
Analgesic supplementation with ketamine, > 20 mg propofol, > 2 mg midazolam, > 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine
Measured: 90 minutes
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
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start10 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon M Togioka, Oregon Health and Science University
- Investigators
- Brandon M Togioka, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206044
- Sponsor's protocol ID
- 25364
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18547291Russell 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.
PubMed 15321392Ousley 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.
PubMed 23061397Hoyle 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.
PubMed 25388969Russell 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.
PubMed 15636981de 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.
PubMed 35289377Yentis 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.
PubMed 16256334
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
- ClinicalTrials.gov ID
- NCT06206044
- Acronym / sponsor ID
- 25364
- Conditions
- Cesarean Section, Anesthesia, Obstetric
- Keywords
- Spinal anesthesia, bupivacaine, Sensory dermatomal level
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Conversion to another anesthetic technique (general anesthesia or activation of the epidural catheter)
- Inadequate anesthesia (analgesic supplementation with ketamine, > 20 mg propofol, > 2 mg midazolam, > 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Drug: Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphineHealthy 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. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphineAlso: MarcainePatients will receive standard intrathecal medications for urgent and scheduled cesarean delivery at the study site. All study subjects will receive bupivacaine, fentanyl, and morphine. | Drug | Study Cohort |
Primary outcome
Number of participants with spinal failure
Time frame: 90 minutes
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
3 secondary outcomes
Number of participants with conversion to another anesthetic technique
Time frame: 90 minutes
Number of participants with inadequate anesthesia
Time frame: 90 minutes
Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction
Time frame: 2 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 18547291Kinsella 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.
- Background: PubMed 15321392Russell 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.
- Background: PubMed 23061397Ousley 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.
- Background: PubMed 25388969Hoyle 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.
- Background: PubMed 15636981Russell 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.
- Background: PubMed 35289377de 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.
- Background: PubMed 16256334Yentis 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon M Togioka, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Anesthesia, Obstetric, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with spinal failure (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06206044, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.