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Completed

NCT Number: NCT02137135

Menstrual Phase and Postoperative Pain

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.

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Key information

Conditions

Acute Postoperative Pain Chronic Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAD Scale

Other

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Other names: The anxiety/depression scale

The SF 12 test

Other

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Other names: SHORT FORM 12

Visual analogue score

Other

Visual analogue score vas used to evaluate pain.

Other names: VAS score

Primary outcomes

  1. Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale

    Time frame: 3 months

Secondary outcomes

  1. The anxiety and depression was evaluated with Hospital anxiety and depression scale.

    Time frame: 3 months

Other outcomes

  1. Quality of life was evaluated with SF 12 test.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 13, 2014
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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