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

Effect of Menstrual Cyclus Phases of Menstrual Cyclus Phases 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Gynecological; Surgery (Previous), Affecting Fetus
• Intervention / Treatment: Other: follicular cyclus; Other: luteal cyclus

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Yozgat, Turkey
    • Bozok University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Volunteer patients to undergo elective laparoscopic gynecological surgery by the Department of Obstetrics and Gynecology

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between mu opioid receptor levels in menstrual cycle phases	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between mu opioid receptor levels and postoperative pain	Correlation between mu opioid receptor levels and postoperative pain	6 months

Collaborators and Investigators

• Sponsor: Bozok University
• Investigators: Study Chair: Ökkeş Miniksar, Asist.Prof, Yozgat Bozok University

Publications and helpful links

General Publications

• Miniksar OH, Onat T, Gocmen AY, Honca M. Serum levels of mu-opioid receptor according to menstrual cycle phases are associated with postoperative pain and opioid consumption in laparoscopic gynecological surgeries: a prospective observational study. Ir J Med Sci. 2022 Sep 12. doi: 10.1007/s11845-022-03146-z. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: menstrual cycle; Mu-opioid receptor; Gynecological laparoscopic operation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 189_2019.12.11_07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No