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

NCT04690491 | Completed

• 1 other identifier: 189_2019.12.11_07
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecological; Surgery (Previous), Affecting Fetus; Postoperative Pain

Keywords

Mu-opioid receptor; Gynecological laparoscopic operation; menstrual cycle

Outcome Measures

Primary Outcomes (1)

• Difference between mu opioid receptor levels in menstrual cycle phases

  6 months

Secondary Outcomes (1)

• Correlation between mu opioid receptor levels and postoperative pain

  6 months

Interventions

follicular cyclus OTHER

Days of cyclus 6-12

luteal cyclus OTHER

Days of cyclus 20-24

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bozok University Medical Center

Yozgat, Turkey (Türkiye)

Location

Related Publications (1)

• 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. 2023 Aug;192(4):1847-1854. doi: 10.1007/s11845-022-03146-z. Epub 2022 Sep 12.

  PMID: 36094733 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ökkeş Miniksar, Asist.Prof

  YOZGAT BOZOK UNIVERSITY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: May 15, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 2, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)