The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section

NCT06304246 | Not Yet Recruiting

• 1 other identifier: FU-S.OZCAN 001
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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 mothers\' 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. Patients\' 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.

Conditions

Obstetric Pain; Cesarean Section; Postoperative Pain

Keywords

postoperative pain; cesarean section; pain threshold; obstetric pain

Outcome Measures

Primary Outcomes (2)

• Preoperative Asprosin Level

  Serum asprosin measurements, blood will be drawn in the preoperative waiting room before the application of spinal anesthesia.

  Before the application of spinal anesthesia

• Postoperative Pain

  Postoperative pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  postoperative 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour

Secondary Outcomes (1)

• Postoperative analgesic consumption

  First 24 hours postoperatively

Study Arms (2)

Labor Pain Group (LPG)

LPG; pregnant women who will undergo emergency C-section with labor pain. Labor pain will be defined as having 3 or more regular uterine contractions in 20 minutes or \>120 Montevideo units of uterine performance observed during non-stress testing (NST) conducted at the Obstetrics Clinic.

Other: Measurement Pain Threshold; Other: Measurement of Serum Asprosin

No Pain Group (NPG)

NPG; pregnant women who will undergo elective C-section without labor pain.

Other: Measurement Pain Threshold; Other: Measurement of Serum Asprosin

Interventions

Measurement Pain Threshold OTHER

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 kg/cm2/s. The pressure applied when the patient perceives pain will be recorded in kg/cm2. The measurement will be repeated three times for each patient, and the average will be recorded as the pain threshold value.

Labor Pain Group (LPG); No Pain Group (NPG)

Measurement of Serum Asprosin OTHER

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 -20°C to measure serum asprosin levels. After all patient blood is collected, serum asprosin will be evaluated with a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.

Labor Pain Group (LPG); No Pain Group (NPG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who applied to the Obstetrics and Gynecology Clinic at Fırat University Hospital and were planned for elective cesarean section and requested spinal anesthesia for cesarean section will participate.

You may qualify if:

• pregnant women who are scheduled for elective cesarean section and request spinal anesthesia for cesarean surgery,

You may not qualify if:

• Being under the age of 18
• Having an abnormal pregnancy with preeclampsia, eclampsia, gestational diabetes, or hypertension
• Having a comorbid desease, systemic diseases, cardiovascular disease
• Having diabetes, obesity, or infection

Sponsors & Collaborators

• Firat University: lead

MeSH Terms

Conditions

Labor Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Sibel Ozcan, Associate Professor

CONTACT

+90-424-2370000-2977; s.ozcan@firat.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03