Menstrual Phase and Postoperative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Postoperative Pain; Chronic Postoperative Pain
• Intervention / Treatment: Other: HAD scale; Other: The SF 12 test; Other: Visual analogue score

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Aydin, Turkey, 09100
    • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Quality of life was evaluated with SF 12 test.	3 months

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Betul Kozanhan, Specialist Doctor, Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey; Principal Investigator: Ayse Ilksen Egilmez, Specialist Doctor, Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey; Principal Investigator: Aykut Soyder, Assistant Professor, Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey; Principal Investigator: Fabrizio Galimberti, Medical Student, Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio; Principal Investigator: Daniel I. Sessler, Professor and Ch, Department of Outcomes Research, Cleveland Clinic; Principal Investigator: Alparslan Turan, Associate Professor, Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland Clinic; Principal Investigator: Osman Nuri Aydın, Professor, Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.brainresbull.2005.05.009.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: menstrual cycle; chronic postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SARI-05