Acute Postoperative PainEarly Phase 1NCT02137135
Menstrual Phase and Postoperative Pain
A Early Phase 1 study testing HAD scale, The SF 12 test and Visual analogue score in people with Acute Postoperative Pain and Chronic Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Postoperative Pain, Chronic Postoperative Pain
- What is being tested?
- HAD scale, The SF 12 test and Visual analogue score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2012to Nov 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a negative urine pregnancy test
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100
About this study
Official title: The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy
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.
Read the 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.
- Being tested
- HAD scale, The SF 12 test, Visual analogue score
- Keywords
- chronic postoperative pain, menstrual cycle
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAD scaleOther
Also called The anxiety/depression scale
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
The SF 12 testOther
Also called SHORT FORM 12
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
Visual analogue scoreOther
Also called VAS score
Visual analogue score vas used to evaluate pain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HAD scale; Other: The SF 12 test; Other: Visual analogue score |
| 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. Receives: Other: HAD scale; Other: The SF 12 test; Other: Visual analogue score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
Measured: 3 months
Secondary outcomes (1)
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
- Investigators
- Betul Kozanhan, Specialist Doctor, Principal investigator, Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; TurkeyAyse Ilksen Egilmez, Specialist Doctor, Principal investigator, Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; TurkeyAykut Soyder, Assistant Professor, Principal investigator, Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; TurkeyFabrizio Galimberti, Medical Student, Principal investigator, Cleveland ClinicLernerCollege of Medicine, Cleveland, OhioDaniel I. Sessler, Professor and Ch, Principal investigator, The Cleveland ClinicAlparslan Turan, Associate Professor, Principal investigator, Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland ClinicOsman Nuri Aydın, Professor, Principal investigator, Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137135
- Sponsor's protocol ID
- SARI-05
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16023915
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02137135
- Acronym / sponsor ID
- SARI-05
- Keywords
- chronic postoperative pain, menstrual cycle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| follicular phase | Experimental | Other: HAD scale, Other: The SF 12 test, Other: Visual analogue scoreVisual 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 | Other: HAD scale, Other: The SF 12 test, Other: Visual analogue scoreVisual 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with a negative urine pregnancy test
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAD scaleAlso: The anxiety/depression scaleThe anxiety/depression scale (HAD) was used to assess anxiety and depression. | Other | follicular phase, luteal phase |
| The SF 12 testAlso: SHORT FORM 12The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. | Other | follicular phase, luteal phase |
| Visual analogue scoreAlso: VAS scoreVisual analogue score vas used to evaluate pain. | Other | follicular phase, luteal phase |
Primary outcome
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
Time frame: 3 months
1 secondary outcome
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Results publication: PubMed 16023915Kuba 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betul Kozanhan, Specialist Doctor principal investigator
Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey
Ayse Ilksen Egilmez, Specialist Doctor principal investigator
Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey
Aykut Soyder, Assistant Professor principal investigator
Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HAD scale, The SF 12 test and Visual analogue score in people with Acute Postoperative Pain and Chronic Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.