Menstrual Phase and Postoperative Pain

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137135

Enrollment

Registered

2014-05-13

Start date

2012-08-31

Completion date

2013-11-30

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Postoperative Pain, Chronic Postoperative Pain

Keywords

chronic postoperative pain, menstrual cycle

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.

Interventions

OTHERHAD scale

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

OTHERThe SF 12 test

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

OTHERVisual analogue score

Visual analogue score vas used to evaluate pain.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026