The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Acute Postoperative Pain
- Sponsor
- Aydin Adnan Menderes University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
SINEM SARI
MD, Assistant Professor
Aydin Adnan Menderes University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
Time Frame: 3 months
Secondary Outcomes
- The anxiety and depression was evaluated with Hospital anxiety and depression scale.(3 months)