Clinical trial NCT03107559: Perfusion Index and Labor Analgesia
Official title: Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: perfüsion Index in Removal of the Epidural Analgesia
Keywords: perfüsion index
epidural analgesia
labor
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery

Brief 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 the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.


Eligibility criteria: Inclusion Criteria:

* women who will give normal spontaneous vaginal delivery
* Between the ages of 18-45

Exclusion Criteria:

* 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

Primary outcomes:
measure: relationship between Visual analogue scale and Perfüsion index
timeFrame: three month
Secondary outcomes:
measure: relationship between heart rate and Perfüsion index
timeFrame: three month
measure: relationship between non-invazive blood pressure and Perfüsion index
timeFrame: three month
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
affiliation: Erzincan University
name: ilke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tousignant-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.
citation: Ledowski 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.
citation: Bird 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.
citation: Nishimura 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.