Menstrual Phase and Postoperative Pain

Acute Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137135
• Other study ID #: SARI-05
• 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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Chronic Postoperative Pain
• Pain, Postoperative

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