Postoperative PainNCT01706549
Clinical Analysis of Pain After Hysterectomy
An observational study of Postoperative Pain, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are: 1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain. 2. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Postoperative Pain
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.
Who may be able to join
- hysterectomy 1-3 years previously
- suffering from pain 6months postsurgically
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:
- to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
- to reveal the type of pain, neuropathic, nociceptive or idiopathic.
- to reveal the impact of pain on quality of life.
Read the detailed description
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.
6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.
- Conditions
- Postoperative Pain
- Keywords
- Chronic pain, Hysterectomy, Quality of life
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Posthysterectomy pain | Observational study on posthysterectomy pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of Chronic Pain After Hysterectomy
Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
Measured: 1-3 years after hysterectomy
Secondary outcomes (2)
Quality of Life After Hysterectomy
Quality of life as measured by the SF-36, which consists of 8 scales.
Measured: 1-3 years after hysterectomy
Is the Pain Due to Hysterectomy?
Number of patients having posthysterectomy pain versus other pain
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satu Pokkinen, MD, Principal investigator, Tampere University HospitalMaija-Liisa Kalliomäki, MD, PhD, Study director, Tampere University HospitalKari Nieminen, MD, Doc, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706549
- Sponsor's protocol ID
- R11190
- Status last verified
- Dec 2016
- First submitted
- 10 Oct 2012
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT01706549
- Acronym / sponsor ID
- R11190
- Conditions
- Postoperative Pain
- Keywords
- Chronic pain, Hysterectomy, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 2 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:
- to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
- to reveal the type of pain, neuropathic, nociceptive or idiopathic.
- to reveal the impact of pain on quality of life.
Detailed description
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.
6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posthysterectomy pain | – | –Observational study on posthysterectomy pain |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.
Key inclusion criteria (2 listed)
- hysterectomy 1-3 years previously
- suffering from pain 6months postsurgically
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of Chronic Pain After Hysterectomy
Time frame: 1-3 years after hysterectomy
Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
2 secondary outcomes
Quality of Life After Hysterectomy
Time frame: 1-3 years after hysterectomy
Is the Pain Due to Hysterectomy?
Time frame: 1-3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Satu Pokkinen, MD principal investigator
Tampere University Hospital
Maija-Liisa Kalliomäki, MD, PhD study director
Tampere University Hospital
Kari Nieminen, MD, Doc principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Tampere University Hospital at 1 site in Finland.
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 2 inclusion and 1 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 Feb 2017. 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 Finland. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Type of Chronic Pain After Hysterectomy (time frame: 1-3 years after hysterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2017.