Menstrual Phase and Postoperative Pain

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy

Conditions
-----------------
Acute Postoperative Pain, Chronic Postoperative Pain

Intervention / Treatment
-----------------
* Other: HAD scale
* Other: The SF 12 test
* Other: Visual analogue score


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: follicular phase<br>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 scale<br>* The anxiety/depression scale (HAD) was used to assess anxiety and depression.<br>* Other names: The anxiety/depression scale;Other: The SF 12 test<br>* The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.<br>* Other names: SHORT FORM 12;Other: Visual analogue score<br>* Visual analogue score vas used to evaluate pain.<br>* Other names: VAS score;|
| Active Comparator: luteal phase<br>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 scale<br>* The anxiety/depression scale (HAD) was used to assess anxiety and depression.<br>* Other names: The anxiety/depression scale;Other: The SF 12 test<br>* The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.<br>* Other names: SHORT FORM 12;Other: Visual analogue score<br>* Visual analogue score vas used to evaluate pain.<br>* Other names: VAS score;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The anxiety and depression was evaluated with Hospital anxiety and depression scale. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic postoperative pain, menstrual cycle