Labor PainNCT05881395
Assessment of Sensory Block During Labour Epidural Analgesia in Patients Experiencing Pain During First Stage of Labour.
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Epidural analgesia is the gold standard for pain control during labour and an essential component of delivering effective and safe epidural analgesia is the assessment of the epidural sensory block. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2023to 3 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Adult
Study population: Patients admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour and experience pain that is addressed by the anesthesiologist.
Who may be able to join
- ASA (American Society of Anesthesiologists) Physical Status Classification II or III
- Patients admitted to labour and delivery unit at Mount Sinai Hospital in their first stage of labour
- Patients who have a labour epidural that has been initiated as an epidural, CSE (combined spinal epidural) or a dural puncture epidural (DPE).
- Patients who are experiencing pain, defined as Visual Numerical Rating Score of more than 1/10, despite our institution's standard epidural Programmed Intermittent Epidural Bolus maintenance regimen and request a manual epidural top-up for the first time
- Have capacity to consent to the study
Who cannot join
- Patients with a language barrier that may interfere with accurate response to sensory block assessment
- Patients with medical conditions that would compromise sensitivity to cold or pinprick assessments
- patients who sustained unintentional dural puncture, those requiring change in our standard epidural maintenance regimen or those who have had a failed epidural requiring replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Sensory Block During Labour Epidural Analgesia: a Prospective Cohort Study to Investigate the Upper and Lower Sensory Block Levels (USBL and LSBL) to Ice and Pinprick in Patients Experiencing Pain During First Stage of Labour.
Epidural analgesia is the gold standard for pain control during labour and an essential component of delivering effective and safe epidural analgesia is the assessment of the epidural sensory block. There is significant literature on the assessment of sensory block during spinal anesthesia for cesarean section but limited studies exploring the assessment of sensory blockade in labour analgesia.
Prior studies have documented two thresholds of sensory block to both ice and pinprick: one defined as the lower sensory block level (LSBL) where the patient is able to notice a cold or sharp sensation but perceives that is not as sharp or cold as a control area and the other the upper sensory block level (USBL) where the patient perceives the cold or sharp sensation is at the same temperature or sharpness as the control area.
The goal of this study is to contribute to the standardization of the assessment of sensory block levels during labour epidural analgesia by studying patients with labour epidurals who are experiencing pain and determining the LSBL and USBL and how these change as the patients become comfortable following the administration of manual epidural top ups.
Read the detailed description
The pain pathways involved in the process of labour and delivery have been well established. Nociceptive stimuli during first stage of labour are transmitted via the T10 to L1 posterior nerve root ganglia, while the nociceptive stimuli during second stage of labour are transmitted via the L1 and S2 to S4 (pudendal nerve) posterior nerve root ganglia. Although these pain pathways are well established, there is no information in the literature as to what level or depth of sensory block, assessed by current clinical practices, is required for effective labour analgesia. This information is critical for planning and safety of epidural analgesia during labour.
The investigators hypothesize that the LSBL to either cold or pinprick would be below dermatome T10 in patients receiving labour epidural analgesia during first stage of labour and who are experiencing pain. The investigators also hypothesize that upon receiving a top-up and re-establishment of effective analgesia, (a) the LSBL would be at or above dermatome T10 or (b) USBL would increase to T10 or above T10 if USBL was below T10 before receiving a top-up.
- Conditions
- Labor Pain
- Keywords
- epidural analgesia, sensory block, programmed intermittent epidural bolus
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with epidural analgesia experiencing pain during labor | Patients reporting pain will have their sensory block checked using ice and pinprick tests, prior to, and following and epidural top-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower sensory block level to ice when the patient is experiencing pain
The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Measured: 5 minutes
Upper sensory block level to ice when the patient is experiencing pain
The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Measured: 5 minutes
Lower sensory block level to pinprick when the patient is experiencing pain
The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Measured: 5 minutes
Upper sensory block level to pinprick when the patient is experiencing pain
The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Measured: 5 minutes
Secondary outcomes (11)
Verbal Numeric Rating Score (VNRS) at the time of request of assessment by anesthesiologist
The patient will be asked to report their VNRS (0-10), where 0 is no pain and 10 is the worst pain imaginable
Measured: 5 minutes
Verbal Numeric Rating Score (VNRS) at 10 minutes after each epidural top-up administered.
The patient will be asked to report their VNRS (0-10), where 0 is no pain and 10 is the worst pain imaginable, 10 minutes after epidural top-ups are administered.
Measured: 10 minutes
Lower sensory block level to ice following epidural top-up
The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be checked 10 minutes following each top-up or when the patient's pain is reported as 0 or 1.
Measured: 5 minutes
Upper sensory block level to ice following epidural top-up
The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss. This will be checked 10 minutes following each top-up or when the patient's pain is reported as 0 or 1.
Measured: 5 minutes
Lower sensory block level to pinprick following epidural top-up
The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation. This will be checked 10 minutes following each top-up or when the patient's pain is reported as 0 or 1.
Measured: 5 minutes
Upper sensory block level to pinprick following epidural top-up
The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss. This will be checked 10 minutes following each top-up or when the patient's pain is reported as 0 or 1.
Measured: 5 minutes
Motor block score using Bromage score at the time of request of assessment by anesthesiologist
Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Measured: 5 minutes
Motor block score using Bromage score following epidural top-up
Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle. This will be checked 10 minutes following each top-up or when the patient's pain is reported as 0 or 1.
Measured: 5 minutes
Number of epidural top-ups required
The number of epidural top-ups documented by the anesthesiologist that were required to achieve VNRS of 0 or 1.
Measured: 20 minutes
Type of pain: questionnaire
Patients will be asked to describe their pain as: sharp/dull/pressure.
Measured: 20 minutes
Location of pain: questionnaire
Patients will be asked to describe the location of their pain as: abdomen/back/perineum
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start16 Jun 2023
- Primary completion2 Dec 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881395
- Sponsor's protocol ID
- 23-01
- Status last verified
- Feb 2024
- First submitted
- 19 May 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kordich L, Ghiringhelli JP, George RB, Downey K, Ye XY, Carvalho J. Characterizing patterns of sensory loss during labor epidural analgesia: a prospective study of breakthrough pain. Int J Obstet Anesth. 2025 Nov;64:104753. doi: 10.1016/j.ijoa.2025.104753. Epub 2025 Aug 12.
PubMed 40876244
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sensory Block During Labour Epidural Analgesia: a Prospective Cohort Study to Investigate the Upper and Lower Sensory Block Levels (USBL and LSBL) to Ice and Pinprick in Patients Experiencing Pain During First Stage of Labour.
- ClinicalTrials.gov ID
- NCT05881395
- Acronym / sponsor ID
- 23-01
- Conditions
- Labor Pain
- Keywords
- epidural analgesia, sensory block, programmed intermittent epidural bolus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 31 May 2023 (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.
Epidural analgesia is the gold standard for pain control during labour and an essential component of delivering effective and safe epidural analgesia is the assessment of the epidural sensory block. There is significant literature on the assessment of sensory block during spinal anesthesia for cesarean section but limited studies exploring the assessment of sensory blockade in labour analgesia.
Prior studies have documented two thresholds of sensory block to both ice and pinprick: one defined as the lower sensory block level (LSBL) where the patient is able to notice a cold or sharp sensation but perceives that is not as sharp or cold as a control area and the other the upper sensory block level (USBL) where the patient perceives the cold or sharp sensation is at the same temperature or sharpness as the control area.
The goal of this study is to contribute to the standardization of the assessment of sensory block levels during labour epidural analgesia by studying patients with labour epidurals who are experiencing pain and determining the LSBL and USBL and how these change as the patients become comfortable following the administration of manual epidural top ups.
Detailed description
The pain pathways involved in the process of labour and delivery have been well established. Nociceptive stimuli during first stage of labour are transmitted via the T10 to L1 posterior nerve root ganglia, while the nociceptive stimuli during second stage of labour are transmitted via the L1 and S2 to S4 (pudendal nerve) posterior nerve root ganglia. Although these pain pathways are well established, there is no information in the literature as to what level or depth of sensory block, assessed by current clinical practices, is required for effective labour analgesia. This information is critical for planning and safety of epidural analgesia during labour.
The investigators hypothesize that the LSBL to either cold or pinprick would be below dermatome T10 in patients receiving labour epidural analgesia during first stage of labour and who are experiencing pain. The investigators also hypothesize that upon receiving a top-up and re-establishment of effective analgesia, (a) the LSBL would be at or above dermatome T10 or (b) USBL would increase to T10 or above T10 if USBL was below T10 before receiving a top-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with epidural analgesia experiencing pain during labor | – | –Patients reporting pain will have their sensory block checked using ice and pinprick tests, prior to, and following and epidural top-up. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour and experience pain that is addressed by the anesthesiologist.
Key inclusion criteria (5 listed)
- ASA (American Society of Anesthesiologists) Physical Status Classification II or III
- Patients admitted to labour and delivery unit at Mount Sinai Hospital in their first stage of labour
- Patients who have a labour epidural that has been initiated as an epidural, CSE (combined spinal epidural) or a dural puncture epidural (DPE).
- Patients who are experiencing pain, defined as Visual Numerical Rating Score of more than 1/10, despite our institution's standard epidural Programmed Intermittent Epidural Bolus maintenance regimen and request a manual epidural top-up for the first time
- Have capacity to consent to the study
Key exclusion criteria (3 listed)
- Patients with a language barrier that may interfere with accurate response to sensory block assessment
- Patients with medical conditions that would compromise sensitivity to cold or pinprick assessments
- patients who sustained unintentional dural puncture, those requiring change in our standard epidural maintenance regimen or those who have had a failed epidural requiring replacement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lower sensory block level to ice when the patient is experiencing pain
Time frame: 5 minutes
The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Upper sensory block level to ice when the patient is experiencing pain
Time frame: 5 minutes
The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Lower sensory block level to pinprick when the patient is experiencing pain
Time frame: 5 minutes
The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
Upper sensory block level to pinprick when the patient is experiencing pain
Time frame: 5 minutes
The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss. This will be checked when the patient is experiencing pain and requesting manual administration of an epidural bolus.
11 secondary outcomes
Verbal Numeric Rating Score (VNRS) at the time of request of assessment by anesthesiologist
Time frame: 5 minutes
Verbal Numeric Rating Score (VNRS) at 10 minutes after each epidural top-up administered.
Time frame: 10 minutes
Lower sensory block level to ice following epidural top-up
Time frame: 5 minutes
Upper sensory block level to ice following epidural top-up
Time frame: 5 minutes
Lower sensory block level to pinprick following epidural top-up
Time frame: 5 minutes
Upper sensory block level to pinprick following epidural top-up
Time frame: 5 minutes
Motor block score using Bromage score at the time of request of assessment by anesthesiologist
Time frame: 5 minutes
Motor block score using Bromage score following epidural top-up
Time frame: 5 minutes
Number of epidural top-ups required
Time frame: 20 minutes
Type of pain: questionnaire
Time frame: 20 minutes
Location of pain: questionnaire
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40876244Kordich L, Ghiringhelli JP, George RB, Downey K, Ye XY, Carvalho J. Characterizing patterns of sensory loss during labor epidural analgesia: a prospective study of breakthrough pain. Int J Obstet Anesth. 2025 Nov;64:104753. doi: 10.1016/j.ijoa.2025.104753. Epub 2025 Aug 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jose Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
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 Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lower sensory block level to ice when the patient is experiencing pain (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 NCT05881395, which also lists 1 linked publication.
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 23 Feb 2024.