Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304246
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-26
Brief Title:
The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section
Sponsor:
Firat University
Organization:
Firat University
Study Overview
Official Title:
Is Preoperative Serum Asprosin Level Associated With Preoperative Pain Threshold and Postoperative Analgesic Consumption in Patients Undergoing Cesarean Section Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite energy lipid carbohydrate metabolism regulation of blood pressure and inflammation One of these is asprosin discovered in 2016 which is secreted from white adipose tissue It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity diabetes and insulin resistance Some adipokines such as leptin adiponectin or resistin are found in increasing levels in the blood and placenta as pregnancy progresses The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism can interfere with placental development and affect pregnancy outcomes and fetal growth Adipokines associated with appetite energy lipid and carbohydrate metabolism have been shown to be effective in modulating pain in recent years High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures
It is known that one of the most important factors affecting mothersamp39 approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain Almost one in five patients experiences severe acute pain after Cesarean section Pain can be perceived differently by patients and even with the same anesthesia technique some patients may experience more severe pain Patientsamp39 perception of pain is influenced by many factors such as pain threshold mood hormonal balance central sensitization and genetic factors
We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period Additionally we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels
In this study we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use
It is known that one of the most important factors affecting mothersamp39 approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain Almost one in five patients experiences severe acute pain after Cesarean section Pain can be perceived differently by patients and even with the same anesthesia technique some patients may experience more severe pain Patientsamp39 perception of pain is influenced by many factors such as pain threshold mood hormonal balance central sensitization and genetic factors
We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period Additionally we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels
In this study we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use
Detailed Description:
Subjects A total of 50 pregnant women who are scheduled for elective cesarean section and request spinal anesthesia for cesarean surgery will be enrolled in the study Patients will be divided into two groups as follows the labor pain group LPG pregnant women who will undergo emergency C-section with labor pain and the no pain group NPG pregnant women who will undergo elective C-section without labor pain Labor pain will be defined as having 3 or more regular uterine contractions in 20 minutes or gt120 Montevideo units of uterine performance observed during non-stress testing NST conducted at the Obstetrics Clinic
Patients under the age of 18 those with preeclampsia eclampsia gestational diabetes or hypertension patients with abnormal pregnancies systemic diseases or diabetes will be excluded from the study
Patient characteristics such as age height weight body mass index ASA and Mallampati scores gestational week previous cesarean section count existing medical conditions family history smoking and alcohol use status and pregnancy-related conditions and complications will be recorded
Measurement of Serum Asprosin For serum asprosin measurements blood will be drawn in the preoperative waiting room before the application of spinal anesthesia The blood samples will be centrifuged and the serum will be stored at -20C to measure serum asprosin levels
Measurement Pain Threshold Manual dolorimetry will be used to assess the pain threshold in the non-dominant hand of patients in the preoperative waiting room prior to spinal anesthesia The dolorimeter head will be placed vertically on the wrist of the non-dominant hand and pressure will be applied with increments of 1 kgcm2s The pressure applied when the patient perceives pain will be recorded in kgcm2 The measurement will be repeated three times for each patient and the average will be recorded as the pain threshold value
Postoperative Pain Severity Postoperative pain severity will be evaluated using the visual analog scale VAS Before the evaluation patients will be informed about the VAS and its pain scoring system which ranges from 0 no pain to 10 extreme pain All patients will be monitored carefully and their VAS scores will be recorded at 1 2 4 6 12 and 24 h postoperatively
Consumption of Postoperative Analgesic For postoperative analgesia patients will be provided with tramadol-based patient-controlled analgesia The time of the first analgesic requirement and the total amount of analgesic used after 24 hours will be recorded
Statistics Continuous variables will be expressed as mean standard deviation The normal distribution of numerical variables will be checked using the Kolmogorov-Smirnov test Independent sample t-test will be used for comparing two independent groups when data are normally distributed and the Mann-Whitney U test will be used when data are not normally distributed Spearman39s rho correlation coefficient will be used to examine the relationships between asprosin levels pain threshold VAS score and analgesic consumption Multiple regression analysis will be performed to examine the effects of asprosin levels and group variables on analgesic consumption and pain threshold P lt005 will be considered statistically significant for all analyses
Patients under the age of 18 those with preeclampsia eclampsia gestational diabetes or hypertension patients with abnormal pregnancies systemic diseases or diabetes will be excluded from the study
Patient characteristics such as age height weight body mass index ASA and Mallampati scores gestational week previous cesarean section count existing medical conditions family history smoking and alcohol use status and pregnancy-related conditions and complications will be recorded
Measurement of Serum Asprosin For serum asprosin measurements blood will be drawn in the preoperative waiting room before the application of spinal anesthesia The blood samples will be centrifuged and the serum will be stored at -20C to measure serum asprosin levels
Measurement Pain Threshold Manual dolorimetry will be used to assess the pain threshold in the non-dominant hand of patients in the preoperative waiting room prior to spinal anesthesia The dolorimeter head will be placed vertically on the wrist of the non-dominant hand and pressure will be applied with increments of 1 kgcm2s The pressure applied when the patient perceives pain will be recorded in kgcm2 The measurement will be repeated three times for each patient and the average will be recorded as the pain threshold value
Postoperative Pain Severity Postoperative pain severity will be evaluated using the visual analog scale VAS Before the evaluation patients will be informed about the VAS and its pain scoring system which ranges from 0 no pain to 10 extreme pain All patients will be monitored carefully and their VAS scores will be recorded at 1 2 4 6 12 and 24 h postoperatively
Consumption of Postoperative Analgesic For postoperative analgesia patients will be provided with tramadol-based patient-controlled analgesia The time of the first analgesic requirement and the total amount of analgesic used after 24 hours will be recorded
Statistics Continuous variables will be expressed as mean standard deviation The normal distribution of numerical variables will be checked using the Kolmogorov-Smirnov test Independent sample t-test will be used for comparing two independent groups when data are normally distributed and the Mann-Whitney U test will be used when data are not normally distributed Spearman39s rho correlation coefficient will be used to examine the relationships between asprosin levels pain threshold VAS score and analgesic consumption Multiple regression analysis will be performed to examine the effects of asprosin levels and group variables on analgesic consumption and pain threshold P lt005 will be considered statistically significant for all analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None