NCT02137135

Menstrual Phase and Postoperative Pain

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Postoperative Pain
• Chronic Postoperative Pain

Interventions

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

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2014-05-13
• Last updated: 2014-05-13

Locations

1 site across 1 country: Turkey (Türkiye)