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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02137135
Other study ID # SARI-05
Secondary ID
Status Completed
Phase Phase 0
First received May 12, 2014
Last updated May 12, 2014
Start date August 2012
Est. completion date November 2013

Study information

Verified date May 2014
Source Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
Turkey Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department Aydin

Sponsors (1)

Lead Sponsor Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life was evaluated with SF 12 test. 3 months Yes
Primary Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale 3 months Yes
Secondary The anxiety and depression was evaluated with Hospital anxiety and depression scale. 3 months Yes
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