perfüsion Index in Removal of the Epidural AnalgesiaNCT03107559
Perfusion Index and Labor Analgesia
An observational study of perfüsion Index in Removal of the Epidural Analgesia, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- perfüsion Index in Removal of the Epidural Analgesia
- What is being tested?
- perfüsion index
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2017to 1 Aug 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery
Who may be able to join
- women who will give normal spontaneous vaginal delivery
- Between the ages of 18-45
Who cannot join
- Patients who do not accept the procedure,
- those under 18 years of age - over 45 years,
- those with low platelet counts,
- those with infection at the puncture site,
- those with progressive neurological disease,
- Those with increased intracranial pressure,
- those with hypovolemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincan University
Erzincan
ufuk kuyrukluyıldız, +904462122222
About this study
Official title: Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?
It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.
- Being tested
- perfüsion index
- Keywords
- perfüsion index, epidural analgesia, labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfüsion indexDiagnostic test
Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between Visual analogue scale and Perfüsion index
Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia,
Measured: three month
Secondary outcomes (2)
relationship between heart rate and Perfüsion index
Determination of the relationship between heart rate and PI in patients with normal delivery who undergo epidural analgesia,
Measured: three month
relationship between non-invazive blood pressure and Perfüsion index
Determination of the relationship between non-invazive blood pressure and PI in patients with normal delivery who undergo epidural analgesia,
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start30 May 2017 (estimated)
- Primary completion15 Jul 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for perfüsion Index in Removal of the Epidural AnalgesiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107559
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY pain&pi
- Status last verified
- May 2017
- First submitted
- 5 Apr 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
PubMed 18487245Tousignant-Laflamme Y, Marchand S. Sex differences in cardiac and autonomic response to clinical and experimental pain in LBP patients. Eur J Pain. 2006 Oct;10(7):603-14. doi: 10.1016/j.ejpain.2005.09.003. Epub 2005 Nov 18.
PubMed 16298532Ledowski T, Ang B, Schmarbeck T, Rhodes J. Monitoring of sympathetic tone to assess postoperative pain: skin conductance vs surgical stress index. Anaesthesia. 2009 Jul;64(7):727-31. doi: 10.1111/j.1365-2044.2008.05834.x. Epub 2009 Jan 28.
PubMed 19183409Bird J. Selection of pain measurement tools. Nurs Stand. 2003 Dec 10-16;18(13):33-9. doi: 10.7748/ns2003.12.18.13.33.c3515.
PubMed 14694870Nishimura T, Nakae A, Shibata M, Mashimo T, Fujino Y. Age-related and sex-related changes in perfusion index in response to noxious electrical stimulation in healthy subjects. J Pain Res. 2014 Feb 10;7:91-7. doi: 10.2147/JPR.S57140. eCollection 2014.
PubMed 24550680
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?
- ClinicalTrials.gov ID
- NCT03107559
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY pain&pi
- Keywords
- perfüsion index, epidural analgesia, labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 30 May 2017 (estimated)
- Primary completion
- 15 Jul 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 11 Apr 2017 (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.
It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery
Key inclusion criteria (2 listed)
- women who will give normal spontaneous vaginal delivery
- Between the ages of 18-45
Key exclusion criteria (7 listed)
- Patients who do not accept the procedure,
- those under 18 years of age - over 45 years,
- those with low platelet counts,
- those with infection at the puncture site,
- those with progressive neurological disease,
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 |
|---|---|---|
| perfüsion indexDetermination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia | Diagnostic test | – |
Primary outcome
relationship between Visual analogue scale and Perfüsion index
Time frame: three month
Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia,
2 secondary outcomes
relationship between heart rate and Perfüsion index
Time frame: three month
relationship between non-invazive blood pressure and Perfüsion index
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Background: PubMed 18487245Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
- Background: PubMed 16298532Tousignant-Laflamme Y, Marchand S. Sex differences in cardiac and autonomic response to clinical and experimental pain in LBP patients. Eur J Pain. 2006 Oct;10(7):603-14. doi: 10.1016/j.ejpain.2005.09.003. Epub 2005 Nov 18.
- Results publication: PubMed 19183409Ledowski T, Ang B, Schmarbeck T, Rhodes J. Monitoring of sympathetic tone to assess postoperative pain: skin conductance vs surgical stress index. Anaesthesia. 2009 Jul;64(7):727-31. doi: 10.1111/j.1365-2044.2008.05834.x. Epub 2009 Jan 28.
- Results publication: PubMed 14694870Bird J. Selection of pain measurement tools. Nurs Stand. 2003 Dec 10-16;18(13):33-9. doi: 10.7748/ns2003.12.18.13.33.c3515.
- Results publication: PubMed 24550680Nishimura T, Nakae A, Shibata M, Mashimo T, Fujino Y. Age-related and sex-related changes in perfusion index in response to noxious electrical stimulation in healthy subjects. J Pain Res. 2014 Feb 10;7:91-7. doi: 10.2147/JPR.S57140. eCollection 2014.
- Individual participant dataSharing planned: No
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.
ilke kupeli principal investigator
Erzincan 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 perfüsion Index in Removal of the Epidural Analgesia, run by Erzincan University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 23 May 2017. 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 Turkey (Türkiye). 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 ilke kupeli (5555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between Visual analogue scale and Perfüsion index (time frame: three month). 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 NCT03107559, which also lists 5 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 23 May 2017.