Menstrual Phase and Postoperative Pain

Early Phase 1

Completed

• Conditions: Acute Postoperative Pain; Chronic Postoperative Pain
• Interventions: Other: HAD scale; Other: The SF 12 test; Other: Visual analogue score

• Registration Number: NCT02137135
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Last Update Submitted: 2014-05-12
• Study First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
follicular phase	HAD scale	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.
follicular phase	The SF 12 test	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.
follicular phase	Visual analogue score	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.
luteal phase	HAD scale	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.
luteal phase	The SF 12 test	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.
luteal phase	Visual analogue score	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.

Primary Outcome Measures

Name	Time	Method
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale	3 months

Secondary Outcome Measures

Name	Time	Method
The anxiety and depression was evaluated with Hospital anxiety and depression scale.	3 months

Trial Locations

Locations (1)

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