Labor PainNCT03975816
The Application of Analgesia Nociception Index as an Objective Labor Pain Assessment During Epidural Analgesia
An observational study of Labor Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Analgesia nociception index
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Nov 2019to 21 Aug 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturients received epidural analgesia
Who may be able to join
- Parturients with gestational age more than 35 weeks
- Ages between 20 to 50
- Received epidural analgesia
- American Society of Anesthesiologists classification I or II.
Who cannot join
- 1. Who refused to join the study
- 2. With a history of arrhythmia
- 3. American Society of Anesthesiologists (ASA)Classification >= III
- 4. With a history of cardiovascular, pulmonary, endocrine, neurologic or psychiatric disease
- 5.Using medications that affecting heart rate
- 6. Cannot understand the explanation of the study
- 7. High-risk gestation
- 8. Known fetal anomaly
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian hospital
Changhua, 500
Min-Ling Chen, MD, +886-910-183-202, u9701401@cmu.edu.tw
Shao-Lun Tsao, MD, +886-983-901-710, 117223@cch.org.tw
About this study
Official title: Changhua Christian Hospital, Department of Anesthesiology
Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.
Read the detailed description
Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. Without a convincing objective tool for obstetric pain evaluation during epidural analgesia, the clinicians are hard to adjust adequate epidural drug dosage. Establishing an objective pain index would help the clinicians to have a better pain management during labor.
In 2012, M. Le Guen et al. demonstrated a linear relationship between visual analogical pain scores(VAS) and Analgesia Nociception Index (ANI) values during labor. Their efforts started the application of ANI in obstetric pain monitoring. However, the reliability of ANI in obstetric pain monitoring under epidural analgesia have not yet been verified. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.
- Conditions
- Labor Pain
- Being tested
- Analgesia nociception index
- Keywords
- Analgesia nociception index, Painless labor, epidural analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia nociception indexDevice
Monitor the maternity with Analgesia nociception index
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score
The VAS(visual analog scale) score is a subjective measure for pain. Scores are recorded by making a handwritten mark by the patient on a 10-cm line that represents a continuum between "no pain" and "worst pain." The score will be transferred to a 0-100 index by divided 10 with the distance from the starting point to the written mark (in centimeter) and multiplied by 100. The ANI (Analgesia Nociception Index) score is a 0-100 index derived from heart rate variability which was applied as an objective pain measurement. The larger the index indicated less pain. The correlation of the VAS score and the ANI score will be analyzed to verified the strength of the ANI score in evaluating labor pain during epidural analgesia.
Measured: 90 minutes
Secondary outcomes (1)
The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score
Uterine contraction strength was measured by external cardiotocography with a scare from 0-100.The ANI (Analgesia Nociception Index) score is a 0-100 index derived from heart rate variability which was applied as an objective pain measurement. The larger the index indicated less pain. The correlation of the uterine contraction strength and the ANI score will be analyzed to verified if the ANI score changing with related to uterine contraction.
Measured: 90 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start17 Nov 2019
- Primary completion21 Aug 2022 (estimated)
- Study completion21 Aug 2023 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Lun Tsao, MD, Study director, Changhua Christian Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975816
- Sponsor's protocol ID
- ANIpainlesslabor
- Status last verified
- Aug 2021
- First submitted
- 18 Apr 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individuals participants data for primary outcome measure will be made available
Publications
Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.
PubMed 22360936
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changhua Christian Hospital, Department of Anesthesiology
- ClinicalTrials.gov ID
- NCT03975816
- Acronym / sponsor ID
- ANIpainlesslabor
- Conditions
- Labor Pain
- Keywords
- Analgesia nociception index, Painless labor, epidural analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- 21 Aug 2022 (estimated)
- Study completion
- 21 Aug 2023 (estimated)
- First posted
- 5 Jun 2019 (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 considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.
Detailed description
Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. Without a convincing objective tool for obstetric pain evaluation during epidural analgesia, the clinicians are hard to adjust adequate epidural drug dosage. Establishing an objective pain index would help the clinicians to have a better pain management during labor.
In 2012, M. Le Guen et al. demonstrated a linear relationship between visual analogical pain scores(VAS) and Analgesia Nociception Index (ANI) values during labor. Their efforts started the application of ANI in obstetric pain monitoring. However, the reliability of ANI in obstetric pain monitoring under epidural analgesia have not yet been verified. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients received epidural analgesia
Key inclusion criteria (4 listed)
- Parturients with gestational age more than 35 weeks
- Ages between 20 to 50
- Received epidural analgesia
- American Society of Anesthesiologists classification I or II.
Key exclusion criteria (8 listed)
- 1. Who refused to join the study
- 2. With a history of arrhythmia
- 3. American Society of Anesthesiologists (ASA)Classification >= III
- 4. With a history of cardiovascular, pulmonary, endocrine, neurologic or psychiatric disease
- 5.Using medications that affecting heart rate
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 |
|---|---|---|
| Analgesia nociception indexMonitor the maternity with Analgesia nociception index | Device | – |
Primary outcome
The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score
Time frame: 90 minutes
The VAS(visual analog scale) score is a subjective measure for pain. Scores are recorded by making a handwritten mark by the patient on a 10-cm line that represents a continuum between "no pain" and "worst pain." The score will be transferred to a 0-100 index by divided 10 with the distance from the starting point to the written mark (in centimeter) and multiplied by 100. The ANI (Analgesia Nociception Index) score is a 0-100 index derived from heart rate variability which was applied as an objective pain measurement. The larger the index indicated less pain. The correlation of the VAS score and the ANI score will be analyzed to verified the strength of the ANI score in evaluating labor pain during epidural analgesia.
1 secondary outcome
The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score
Time frame: 90 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 22360936Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.
- Individual participant dataSharing planned: Yes. De-identified individuals participants data for primary outcome measure will be made available
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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.
Shao-Lun Tsao, MD study director
Changhua Christian Hospital, Department of Anesthesiology
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 Changhua Christian Hospital at 1 site in Taiwan.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Aug 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Ling Chen, MD (+886-910-183-202, u9701401@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score (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 NCT03975816, 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 5 Aug 2021.