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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Efficacy of Plan Blocks in Laparoscopic Hysterectomies

NCT05925972

Pain, Postoperative

COMPLETED NA

The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality

NCT06766994

Abdominal Hysterectomy

RECRUITING NA

The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types

NCT05054946

Ovarian Cysts

COMPLETED NA

Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

NCT01442961

Postoperative Pain

COMPLETED NA

Postoperative Pain Score of Laparoscopic Gynecological Surgeries

NCT05296928

Surgical Incision Gynecologic Surgery Postoperative Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecological; Surgery (Previous), Affecting Fetus Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

follicular cyclus

Days of cyclus 6-12

Intervention Type OTHER

luteal cyclus

Days of cyclus 20-24

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes