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

• ClinicalTrials.gov Identifier: NCT04690491
• Recruitment Status: Completed
• First Posted: December 30, 2020
• Last Update Posted: April 20, 2021
• Sponsor: Bozok University
• Information provided by (Responsible Party): Ökkeş Hakan Miniksar, Bozok University

Study Description

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.

Condition or disease	Intervention/treatment
Gynecological; Surgery (Previous), Affecting Fetus; Postoperative Pain	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Official Title: Effect of Menstrual Cyclus Phases of Menstrual Cyclus Phases and Postoperative Pain in Patients With Gynecological Laparoscopy
• Actual Study Start Date: May 15, 2020
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: April 2, 2021

Groups and Cohorts

Intervention Details:

• Other: follicular cyclus
  Days of cyclus 6-12
• Other: luteal cyclus
  Days of cyclus 20-24

Outcome Measures

Primary Outcome Measures :

1. Difference between mu opioid receptor levels in menstrual cycle phases [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Correlation between mu opioid receptor levels and postoperative pain [ Time Frame: 6 months ]
   Correlation between mu opioid receptor levels and postoperative pain

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Turkey

Bozok University Medical Center

Yozgat, Turkey

Sponsors and Collaborators

Bozok University

Investigators

• Study Chair: Ökkeş Miniksar, Asist.Prof; YOZGAT BOZOK UNIVERSITY

More Information

• Responsible Party: Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
• ClinicalTrials.gov Identifier: NCT04690491
• Other Study ID Numbers: 189_2019.12.11_07
• First Posted: December 30, 2020
• Last Update Posted: April 20, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ökkeş Hakan Miniksar, Bozok University:

Mu-opioid receptor; Gynecological laparoscopic operation; menstrual cycle

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations