Menstrual Phase and Postoperative Pain

Aydin Adnan Menderes University

Status and phase: Completed; Early Phase 1

Conditions: Chronic Postoperative Pain; Acute Postoperative Pain

Treatments: Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score

Study type: Interventional

Funder types: Other

Identifiers

NCT02137135

SARI-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

follicular phase

Experimental group

Description:

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.

Treatment:

Other: Visual analogue score

Other: HAD scale

Other: The SF 12 test

luteal phase

Active Comparator group

Description:

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.

Treatment:

Other: Visual analogue score

Other: HAD scale

Other: The SF 12 test