NCT02137135

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 12, 2014

Last Update Submit

May 12, 2014

Conditions

Acute Postoperative PainChronic Postoperative Pain

Keywords

chronic postoperative painmenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale

    3 months

Secondary Outcomes (1)

  • The anxiety and depression was evaluated with Hospital anxiety and depression scale.

    3 months

Other Outcomes (1)

  • Quality of life was evaluated with SF 12 test.

    3 months

Study Arms (2)

follicular phase

EXPERIMENTAL

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.

Other: HAD scaleOther: The SF 12 testOther: Visual analogue score

luteal phase

ACTIVE COMPARATOR

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.

Other: HAD scaleOther: The SF 12 testOther: Visual analogue score

Interventions

HAD scaleOTHER

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

Also known as: The anxiety/depression scale
follicular phaseluteal phase
The SF 12 testOTHER

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

Also known as: SHORT FORM 12
follicular phaseluteal phase
Visual analogue scoreOTHER

Visual analogue score vas used to evaluate pain.

Also known as: VAS score
follicular phaseluteal phase

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with a negative urine pregnancy test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 16023915RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Betul Kozanhan, Specialist Doctor

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

    PRINCIPAL INVESTIGATOR

  • Ayse Ilksen Egilmez, Specialist Doctor

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

    PRINCIPAL INVESTIGATOR

  • Aykut Soyder, Assistant Professor

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

    PRINCIPAL INVESTIGATOR

  • Fabrizio Galimberti, Medical Student

    Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio

    PRINCIPAL INVESTIGATOR

  • Daniel I. Sessler, Professor and Ch

    Department of Outcomes Research, Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Alparslan Turan, Associate Professor

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

    PRINCIPAL INVESTIGATOR

  • Osman Nuri Aydın, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 13, 2014

Study Start

August 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

TU(1)