Menstrual Phase and Postoperative Pain

NCT ID: NCT02137135

Last Updated: 2014-05-13

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

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-11-30

Brief Summary

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

Fluctuations of female sex hormones during the menstrual cycle influence pain perception. Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The investigators tested the primary hypothesis that the women having surgery during their follicular phase have more acute pain and require more opioids than those in the luteal phase, and secondarily the investigators tested that women who have surgery during their follicular phase have more incisional pain at 3 month postoperatively.

Detailed Description

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

127 adult females having laparoscopic cholecystectomy were randomized to have surgery during the luteal or follicular phase of their menstrual cycle. Standardized anesthesia and pain management regimen was given to all patients. Pain and analgesic consumption were evaluated in PACU and every four hours in first 24 hours. Adverse effects were also questioned every four hours. Time to oral intake and ambulation were recorded. Post-surgical pain, hospital anxiety and depression scale, and SF-12 questionnaire were also evaluated at 1- and 3-month visits.

Conditions

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

Acute Postoperative Pain Chronic Postoperative Pain

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

follicular phase

Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Group Type EXPERIMENTAL

HAD scale

Intervention Type OTHER

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

The SF 12 test

Intervention Type OTHER

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Visual analogue score

Intervention Type OTHER

Visual analogue score vas used to evaluate pain.

luteal phase

Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Group Type ACTIVE_COMPARATOR

HAD scale

Intervention Type OTHER

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

The SF 12 test

Intervention Type OTHER

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Visual analogue score

Intervention Type OTHER

Visual analogue score vas used to evaluate pain.

Interventions

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

HAD scale

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Intervention Type OTHER

The SF 12 test

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Intervention Type OTHER

Visual analogue score

Visual analogue score vas used to evaluate pain.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

The anxiety/depression scale SHORT FORM 12 VAS score

Eligibility Criteria

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

Inclusion Criteria

* Women with a negative urine pregnancy test

Exclusion Criteria

* Patients with pre-existing pain syndromes
* Patients using routinely using opioids
* Patients using hormone preparations in the last 6 months
* Patients with hysterectomy
* Patients breastfeeding in the previous 6 months
* Patients with body mass index \>35 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SINEM SARI

MD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Betul Kozanhan, Specialist Doctor

Role: PRINCIPAL_INVESTIGATOR

Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey

Ayse Ilksen Egilmez, Specialist Doctor

Role: PRINCIPAL_INVESTIGATOR

Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey

Aykut Soyder, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey

Fabrizio Galimberti, Medical Student

Role: PRINCIPAL_INVESTIGATOR

Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio

Daniel I. Sessler, Professor and Ch

Role: PRINCIPAL_INVESTIGATOR

Department of Outcomes Research, Cleveland Clinic

Alparslan Turan, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland Clinic

Osman Nuri Aydın, Professor

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Kuba T, Quinones-Jenab V. The role of female gonadal hormones in behavioral sex differences in persistent and chronic pain: clinical versus preclinical studies. Brain Res Bull. 2005 Aug 15;66(3):179-88. doi: 10.1016/j.brainresbull.2005.05.009.

Reference Type RESULT
PMID: 16023915 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SARI-05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nonopioid Analgesics and Cholecystectomy
NCT04622813 COMPLETED PHASE3