PainNCT06929416
Estrogen and Propofol Injection Pain
An observational study of Pain and Estradiol, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study investigates the relationship between serum estrogen concentration and the incidence and severity of propofol injection pain (PIP) in female patients undergoing general anesthesia. The study will include 90 ASA I-II female patients aged 18-45. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Estradiol, Assisted Reproductive Techniques
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2025to 10 Sep 2025
- 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
- Healthy volunteers accepted
- Adult
Study population: The study population consists of adult female patients aged 18 to 45 years, with ASA physical status I or II, who are scheduled for elective surgical procedures under general anesthesia. Participants will be divided into two groups based on their preoperative serum estradiol levels: one group will include women undergoing IVF procedures with supraphysiological estrogen levels, and the other will consist of patients with normal estrogen levels undergoing unrelated elective surgeries.
Who may be able to join
- Female patients aged between 18 and 45 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for surgery under general anesthesia
- Availability of a preoperative serum estradiol (E2) level
- For Group 1: Undergoing IVF procedure with supraphysiological E2 levels (>350 pg/mL)
- For Group 2: Undergoing elective surgery with normal E2 levels (15-350 pg/mL)
Who cannot join
- ASA physical status III or IV
- Pregnant patients
- Perimenopausal women
- Male patients
- Patients younger than 18 or older than 45 years
- History of psychiatric disorders
- Patients undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Serum Estrogen Concentration and Propofol Injection Pain: A Prospective and Observational Study
This prospective observational study investigates the relationship between serum estrogen concentration and the incidence and severity of propofol injection pain (PIP) in female patients undergoing general anesthesia. The study will include 90 ASA I-II female patients aged 18-45. One group will consist of IVF patients with elevated estrogen levels, while the control group will include patients with normal estrogen levels undergoing other elective procedures. Pain will be assessed using a standardized four-point behavioral pain scale. The findings may enhance understanding of hormonal influences on pain and contribute to improving patient comfort during anesthesia induction.
Read the detailed description
This prospective observational study aims to evaluate the association between serum estrogen levels and the incidence and severity of propofol injection pain (PIP) in adult female patients undergoing general anesthesia. Although propofol is a widely used intravenous anesthetic, it frequently causes pain upon injection. Estrogen is believed to play a role in modulating pain perception and inflammatory responses, yet the effects of elevated estrogen levels on PIP are not well understood.
The study will be conducted at a single tertiary hospital and will include 90 ASA I-II female patients aged 18-45 years. One group will consist of IVF patients with elevated serum estradiol levels due to controlled ovarian stimulation. The control group will include patients with normal estradiol levels scheduled for elective procedures under general anesthesia. Preoperative serum estradiol levels will be recorded, and injection pain will be evaluated using a validated four-point behavioral pain scale based on vocal response, facial expression, limb movement, and tearfulness.
Anesthesia induction will follow standard clinical practice without additional interventions. Pain data will be collected through routine clinical observation. The results may offer new insights into hormonal modulation of acute nociceptive responses and help improve patient experiences during anesthesia.
- Conditions
- Pain, Estradiol, Assisted Reproductive Techniques
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women Undergoing IVF With Supraphysiological Estrogen Levels | |
| 2 | Women Undergoing Elective Surgery With Normal Estrogen Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Propofol Injection Pain
Presence or absence of pain during propofol injection, assessed through patient response (verbal reaction, facial grimacing, arm withdrawal, or tearing) and/or verbal confirmation during anesthesia induction. Comparison between patients with normal and supraphysiological estradiol levels.
Measured: Immediately during induction of anesthesia
Secondary outcomes (2)
Severity of Propofol Injection Pain
Pain intensity during propofol injection will be graded using a validated 4-point behavioral scale:
0 = no pain,
- = mild pain (reported only when asked, without behavioral signs),
- = moderate pain (reported when asked and with behavioral signs),
- = severe pain (spontaneous report with strong vocal, facial, or physical reactions such as tearing).
Measured: Immediately during induction of anesthesia
Postoperative Injection Site Reactions
Presence of local signs such as redness, swelling, tenderness, or edema at the injection site will be assessed by a blinded anesthesiologist within 24 hours postoperatively.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start2 May 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
- Investigators
- Mahmut Tutar, MD, Study chair, KONYA CITY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929416
- Sponsor's protocol ID
- 2.02.2025-35906
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy considerations and lack of prior consent for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serum Estrogen Concentration and Propofol Injection Pain: A Prospective and Observational Study
- ClinicalTrials.gov ID
- NCT06929416
- Acronym / sponsor ID
- 2.02.2025-35906
- Conditions
- Pain, Estradiol, Assisted Reproductive Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 16 Apr 2025 (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.
This prospective observational study investigates the relationship between serum estrogen concentration and the incidence and severity of propofol injection pain (PIP) in female patients undergoing general anesthesia. The study will include 90 ASA I-II female patients aged 18-45. One group will consist of IVF patients with elevated estrogen levels, while the control group will include patients with normal estrogen levels undergoing other elective procedures. Pain will be assessed using a standardized four-point behavioral pain scale. The findings may enhance understanding of hormonal influences on pain and contribute to improving patient comfort during anesthesia induction.
Detailed description
This prospective observational study aims to evaluate the association between serum estrogen levels and the incidence and severity of propofol injection pain (PIP) in adult female patients undergoing general anesthesia. Although propofol is a widely used intravenous anesthetic, it frequently causes pain upon injection. Estrogen is believed to play a role in modulating pain perception and inflammatory responses, yet the effects of elevated estrogen levels on PIP are not well understood.
The study will be conducted at a single tertiary hospital and will include 90 ASA I-II female patients aged 18-45 years. One group will consist of IVF patients with elevated serum estradiol levels due to controlled ovarian stimulation. The control group will include patients with normal estradiol levels scheduled for elective procedures under general anesthesia. Preoperative serum estradiol levels will be recorded, and injection pain will be evaluated using a validated four-point behavioral pain scale based on vocal response, facial expression, limb movement, and tearfulness.
Anesthesia induction will follow standard clinical practice without additional interventions. Pain data will be collected through routine clinical observation. The results may offer new insights into hormonal modulation of acute nociceptive responses and help improve patient experiences during anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women Undergoing IVF With Supraphysiological Estrogen Levels |
| 2 | – | –Women Undergoing Elective Surgery With Normal Estrogen Levels |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of adult female patients aged 18 to 45 years, with ASA physical status I or II, who are scheduled for elective surgical procedures under general anesthesia. Participants will be divided into two groups based on their preoperative serum estradiol levels: one group will include women undergoing IVF procedures with supraphysiological estrogen levels, and the other will consist of patients with normal estrogen levels undergoing unrelated elective surgeries.
Key inclusion criteria (6 listed)
- Female patients aged between 18 and 45 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for surgery under general anesthesia
- Availability of a preoperative serum estradiol (E2) level
- For Group 1: Undergoing IVF procedure with supraphysiological E2 levels (>350 pg/mL)
Key exclusion criteria (7 listed)
- ASA physical status III or IV
- Pregnant patients
- Perimenopausal women
- Male patients
- Patients younger than 18 or older than 45 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Propofol Injection Pain
Time frame: Immediately during induction of anesthesia
Presence or absence of pain during propofol injection, assessed through patient response (verbal reaction, facial grimacing, arm withdrawal, or tearing) and/or verbal confirmation during anesthesia induction. Comparison between patients with normal and supraphysiological estradiol levels.
2 secondary outcomes
Severity of Propofol Injection Pain
Time frame: Immediately during induction of anesthesia
Postoperative Injection Site Reactions
Time frame: Within 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy considerations and lack of prior consent for data sharing.
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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.
Mahmut Tutar, MD study chair
KONYA CITY HOSPİTAL
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 Pain and Estradiol, run by Konya City Hospital 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 6 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: finished, as of the sponsor's last update on 16 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Propofol Injection Pain (time frame: Immediately during induction of anesthesia). 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 16 Sep 2025.