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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| follicular phase | Experimental | 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. |
|
| luteal phase | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAD scale | Other | The anxiety/depression scale (HAD) was used to assess anxiety and depression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The anxiety and depression was evaluated with Hospital anxiety and depression scale. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life was evaluated with SF 12 test. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betul Kozanhan, Specialist Doctor | Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey | Principal Investigator |
| Ayse Ilksen Egilmez, Specialist Doctor | Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey | Principal Investigator |
| Aykut Soyder, Assistant Professor | Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey | Principal Investigator |
| Fabrizio Galimberti, Medical Student | Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio | Principal Investigator |
| Daniel I. Sessler, Professor and Ch | Department of Outcomes Research, Cleveland Clinic | Principal Investigator |
| Alparslan Turan, Associate Professor | Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland Clinic | Principal Investigator |
| Osman Nuri Aydın, Professor | Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department | Aydin | 09100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16023915 | Result | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| The SF 12 test | Other | The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. |
|
|
| Visual analogue score | Other | Visual analogue score vas used to evaluate pain. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |