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Completed

NCT Number: NCT04690491

Mü-opioid Receptor Level and Postoperative Pain in Patients With Gynecological Laparoscopy

The hypothesis that gonadal hormones may affect the perception of pain is an interesting research area.

This prospective observational study will undergo elective laparoscopic gynecological surgery to 18-65 years, is planned to participate in ASA 1-3, 60 volunteer patients.

Patients who have known psychiatric disease and drug-users, an important cardiovascular or central nervous system disease, patients with pain syndromes or routinely using opioid, are non-irregular and predictable cycles of menstrual cycles and very urgent patients will not be included in the study.

In our study, we aimed to determine the relationship between menstrual cyclus phases (follicular and luteal) of menstrual cyclus phases (follicular and luteal) in patients to undergo gynecological laparoscopic operation and the relationship between postoperative pain and opioid analgesic consumption.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bozok University Medical Center

Yozgat, Turkey (Türkiye)

About this study

This prospective observational study is planned to include 60 volunteer patients aged 18-45, ASA 1-3, undergoing elective laparoscopic gynecological surgery. With the information to be obtained from the patients whose menstrual cycle regularly lasts 21-35 days, the cycle duration will be determined by counting from the first day of the last mens period. Days 6-12 of the cycle will be grouped as follicular (F), and 20-24 as luteal (L). No surgery will be planned during the mens period (1-5 days). Patients will be excluded on days 13-19 of the cycle to better define the two stages.

Remaining 3 ml of blood from routine venous blood samples taken from patients for preoperative evaluation will be stored to investigate μ-Opioid receptor levels. A continuous 10 cm visual analog scale (VAS) will be used to determine the level of postoperative pain.

Researchers who will make postoperative evaluations will be blind to menstrual cycles.

The sensation of pain will be assessed every 10 minutes in the recovery room, intervening with a bolus of 10 mg iv tramadol for a pain score of 3 to 5 and a bolus of 20 mg for a pain score of more than 5. If the VAS does not drop below 3 after two additional tramadol boluses, rescue analgesia will be provided with 2 mg iv morphine.

Patients will be followed in the ward and observations will be made at 6, 12 and 24 hours.

Patients will be asked to evaluate their resting and coughing pains.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteer,
  • Between the Ages of 18-45,
  • Least Primary School Graduate,
  • Not Using Drugs That May Affect Cognitive Functions,
  • Non-Alcohol Substance Use,
  • Patients Without Psychiatric and Neurological Disease.
  • Those with regular and predictable menstrual cycles

Exclusion criteria

  • Those with known psychiatric disease and drugs,
  • Those with an important cardiovascular or central nervous system disease,
  • Patients with pain syndromes or routinely using opioid,
  • Those whose menstrual cycles last less than 21 days and do not have an irregular and predictable menstrual cycle
  • Very urgent patients

Treatment and study plan

follicular cyclus

Other

Days of cyclus 6-12

luteal cyclus

Other

Days of cyclus 20-24

Primary outcomes

  1. Difference between mu opioid receptor levels in menstrual cycle phases

    Time frame: 6 months

Secondary outcomes

  1. Correlation between mu opioid receptor levels and postoperative pain

    Time frame: 6 months

    Correlation between mu opioid receptor levels and postoperative pain

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

Effect of Menstrual Cyclus Phases of Menstrual Cyclus Phases and Postoperative Pain in Patients With Gynecological Laparoscopy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Apr 20, 2021

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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