Labor PainNCT05187962
Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Labor Pain
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 21 Dec 2021to 27 Jul 2022
- 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 60 years
- Women only
- Adult
Study population: Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour.
Who may be able to join
- ASA Physical Status Classification II and III parturients
- Requested and received a labour epidural
- Capable of consenting to the study
- Have no language barrier which may obfuscate the sensory block assessment
- Are receiving programmed intermittent epidural boluses (PIEB) for maintenance analgesia, which is the Mount Sinai Hospital default maintenance regimen
Who cannot join
- Medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch
- Epidurals performed under a combined spinal-epidural (CSE) or dural puncture epidural (DPE) technique
- Epidurals with a documented unintentional dural puncture
- Inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural
Trial locations and contacts
1 site in 1 country.
About this study
Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.
- Conditions
- Labor Pain
- Keywords
- sensory block, epidural analgesia, 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 receiving epidural analgesia for labor | Sensory block level check Patients will have their sensory block level checked using 3 modalities: ice, pin prick and soft touch (cotton ball). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower sensory block level: ice test
The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception.
Measured: 5 minutes
Upper sensory block level: ice test
The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.
Measured: 5 minutes
Lower sensory block level: pinprick test
The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation.
Measured: 5 minutes
Upper sensory block level: pinprick test
The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss.
Measured: 5 minutes
Sensory block level: soft touch test
The sensory block level using soft touch is defined as the dermatome below which the patient can feel a light touch.
Measured: 5 minutes
Secondary outcomes (1)
Motor block score using Bromage score
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start21 Dec 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
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 CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187962
- Sponsor's protocol ID
- 21-08
- Status last verified
- Oct 2022
- First submitted
- 21 Dec 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casellato JF, Balki M, Wang A, Ye XY, Downey K, Carvalho JCA. Differential sensory block during labour epidural analgesia: a prospective observational study to investigate the relationship of lower and upper sensory block levels to cold, pinprick, and light touch. Can J Anaesth. 2024 Jun;71(6):802-807. doi: 10.1007/s12630-023-02638-5. Epub 2024 Jan 30.
PubMed 38291174
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch
- ClinicalTrials.gov ID
- NCT05187962
- Acronym / sponsor ID
- 21-08
- Conditions
- Labor Pain
- Keywords
- sensory block, epidural analgesia, 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
- 21 Dec 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 12 Jan 2022 (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 remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women receiving epidural analgesia for labor | – | –Sensory block level check Patients will have their sensory block level checked using 3 modalities: ice, pin prick and soft touch (cotton ball). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that receive epidural analgesia for labour.
Key inclusion criteria (5 listed)
- ASA Physical Status Classification II and III parturients
- Requested and received a labour epidural
- Capable of consenting to the study
- Have no language barrier which may obfuscate the sensory block assessment
- Are receiving programmed intermittent epidural boluses (PIEB) for maintenance analgesia, which is the Mount Sinai Hospital default maintenance regimen
Key exclusion criteria (4 listed)
- Medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch
- Epidurals performed under a combined spinal-epidural (CSE) or dural puncture epidural (DPE) technique
- Epidurals with a documented unintentional dural puncture
- Inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural
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: ice test
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.
Upper sensory block level: ice test
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.
Lower sensory block level: pinprick test
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.
Upper sensory block level: pinprick test
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.
Sensory block level: soft touch test
Time frame: 5 minutes
The sensory block level using soft touch is defined as the dermatome below which the patient can feel a light touch.
1 secondary outcome
Motor block score using Bromage score
Time frame: 5 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 25 Oct 2022.
- Derived from this study: PubMed 38291174Casellato JF, Balki M, Wang A, Ye XY, Downey K, Carvalho JCA. Differential sensory block during labour epidural analgesia: a prospective observational study to investigate the relationship of lower and upper sensory block levels to cold, pinprick, and light touch. Can J Anaesth. 2024 Jun;71(6):802-807. doi: 10.1007/s12630-023-02638-5. Epub 2024 Jan 30.
- 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 CA 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 4 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 25 Oct 2022. 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: ice test (time frame: 5 minutes). The study lists 5 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 NCT05187962, 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 25 Oct 2022.