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NCT Number: NCT06929416

Estrogen and Propofol Injection Pain

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.

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Key information

Conditions

Pain Assisted Reproductive Techniques Estradiol Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Severity of Propofol Injection Pain

    Time frame: Immediately during induction of anesthesia

    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).

  2. Postoperative Injection Site Reactions

    Time frame: Within 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Relationship Between Serum Estrogen Concentration and Propofol Injection Pain: A Prospective and Observational Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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