Clinical trial NCT02137135: Menstrual Phase and Postoperative Pain
Official title: The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Postoperative Pain
Chronic Postoperative Pain
Keywords: chronic postoperative pain
menstrual cycle
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
timeFrame: 3 months
Secondary outcomes:
measure: The anxiety and depression was evaluated with Hospital anxiety and depression scale.
timeFrame: 3 months
Other outcomes:
measure: Quality of life was evaluated with SF 12 test.
timeFrame: 3 months
Locations:
city: Aydin
country: Turkey
facility: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Study officials:
affiliation: Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey
name: Betul Kozanhan, Specialist Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey
name: Ayse Ilksen Egilmez, Specialist Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey
name: Aykut Soyder, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
name: Fabrizio Galimberti, Medical Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Outcomes Research, Cleveland Clinic
name: Daniel I. Sessler, Professor and Ch
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland Clinic
name: Alparslan Turan, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey
name: Osman Nuri Aydın, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.