Obstetric PainNCT06304246
The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section
An observational study of Obstetric Pain and Cesarean Section, run by Firat University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetric Pain, Cesarean Section, Postoperative Pain
- What is being tested?
- Measurement Pain Threshold and Measurement of Serum Asprosin
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Oct 2024
- 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: 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.
Who may be able to join
- pregnant women who are scheduled for elective cesarean section and request spinal anesthesia for cesarean surgery,
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Is Preoperative Serum Asprosin Level Associated With Preoperative Pain Threshold and Postoperative Analgesic Consumption in Patients Undergoing Cesarean Section Surgery?"
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.
Read more
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.
Read the 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 \>120 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 -20°C 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 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.
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. Spearman\'s 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 \<0.05 will be considered statistically significant for all analyses.
- Conditions
- Obstetric Pain, Cesarean Section, Postoperative Pain
- Being tested
- Measurement Pain Threshold, Measurement of Serum Asprosin
- Keywords
- postoperative pain, cesarean section, pain threshold, obstetric pain
- Medical subject headings
- Labor Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement Pain ThresholdOther
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.
Measurement of Serum AsprosinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Measurement Pain Threshold; Other: Measurement of Serum Asprosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Asprosin Level
Serum asprosin measurements, blood will be drawn in the preoperative waiting room before the application of spinal anesthesia.
Measured: 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).
Measured: postoperative 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
Secondary outcomes (1)
Postoperative analgesic consumption
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.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Ozcan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304246
- Sponsor's protocol ID
- FU-S.OZCAN 001
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will decide after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Serum Asprosin Level Associated With Preoperative Pain Threshold and Postoperative Analgesic Consumption in Patients Undergoing Cesarean Section Surgery?"
- ClinicalTrials.gov ID
- NCT06304246
- Acronym / sponsor ID
- FU-S.OZCAN 001
- Conditions
- Obstetric Pain, Cesarean Section, Postoperative Pain
- Keywords
- postoperative pain, cesarean section, pain threshold, obstetric pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
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\&#39; 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\&#39; 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 \>120 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 -20°C 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 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.
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. Spearman\'s 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 \<0.05 will be considered statistically significant for all analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor Pain Group (LPG) | – | Other: Measurement Pain Threshold, Other: Measurement of Serum AsprosinLPG; 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. |
| No Pain Group (NPG) | – | Other: Measurement Pain Threshold, Other: Measurement of Serum AsprosinNPG; pregnant women who will undergo elective C-section without labor pain. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- pregnant women who are scheduled for elective cesarean section and request spinal anesthesia for cesarean surgery,
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Measurement Pain ThresholdMeasurement 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. | Other | Labor Pain Group (LPG), No Pain Group (NPG) |
| Measurement of Serum AsprosinMeasurement 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. | Other | Labor Pain Group (LPG), No Pain Group (NPG) |
Primary outcome
Preoperative Asprosin Level
Time frame: Before the application of spinal anesthesia
Serum asprosin measurements, blood will be drawn in the preoperative waiting room before the application of spinal anesthesia.
Postoperative Pain
Time frame: postoperative 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
Postoperative pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
1 secondary outcome
Postoperative analgesic consumption
Time frame: First 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. I will decide after the study is completed.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Pain and Cesarean Section, run by Firat University.
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 1 inclusion and 4 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sibel Ozcan, Associate Professor (+90-424-2370000-2977, s.ozcan@firat.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Asprosin Level (time frame: Before the application of spinal anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.