Chronic Postsurgical PainNCT01537731
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain
An observational study of Chronic Postsurgical Pain, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Chronic Postsurgical Pain
- What is being tested?
- vaginal or laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2009to Oct 2013
- Phase
- Observational
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.
Who may be able to join
- Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
- Age 18-69 years
- Gender: female
- ASA status 1-3
Who cannot join
- Body Mass Index over 35
- Diabetes mellitus
- Liver disease
- Preoperative use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions
Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.
- Conditions
- Chronic Postsurgical Pain
- Being tested
- vaginal or laparoscopic hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal or laparoscopic hysterectomyProcedure or surgery
vaginal hysterectomy or laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| hysterectomy | Patient who previously underwent vaginal or laparoscopic hysterectomy Receives: Procedure: vaginal or laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of persistent postsurgical pain as measured at 6 months after surgery.
Measured: five years
Secondary outcomes (2)
Severity, location, characteristics of persistent postsurgical pain.
Measured: five years
Effect of postsurgical pain on activity, sleep.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startApr 2009
- Primary completionOct 2013
- Study completionOct 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 Chronic Postsurgical 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvi Yli-Hankala, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537731
- Sponsor's protocol ID
- R08031M R09003
- Status last verified
- Oct 2013
- First submitted
- 10 Jan 2012
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pokkinen SM, Nieminen K, Yli-Hankala A, Kalliomaki ML. Persistent posthysterectomy pain: A prospective, observational study. Eur J Anaesthesiol. 2015 Oct;32(10):718-24. doi: 10.1097/EJA.0000000000000318.
PubMed 26258656
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions
- ClinicalTrials.gov ID
- NCT01537731
- Acronym / sponsor ID
- R08031M R09003
- Conditions
- Chronic Postsurgical Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Feb 2012 (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.
Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hysterectomy | – | Procedure: vaginal or laparoscopic hysterectomyPatient who previously underwent vaginal or laparoscopic hysterectomy |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.
Key inclusion criteria (4 listed)
- Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
- Age 18-69 years
- Gender: female
- ASA status 1-3
Key exclusion criteria (4 listed)
- Body Mass Index over 35
- Diabetes mellitus
- Liver disease
- Preoperative use of opioids
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 |
|---|---|---|
| vaginal or laparoscopic hysterectomyvaginal hysterectomy or laparoscopic hysterectomy | Procedure or surgery | hysterectomy |
Primary outcome
Presence of persistent postsurgical pain as measured at 6 months after surgery.
Time frame: five years
2 secondary outcomes
Severity, location, characteristics of persistent postsurgical pain.
Time frame: five years
Effect of postsurgical pain on activity, sleep.
Time frame: five years
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 9 Oct 2013.
- Derived from this study: PubMed 26258656Pokkinen SM, Nieminen K, Yli-Hankala A, Kalliomaki ML. Persistent posthysterectomy pain: A prospective, observational study. Eur J Anaesthesiol. 2015 Oct;32(10):718-24. doi: 10.1097/EJA.0000000000000318.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Postsurgical 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 4 inclusion and 4 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 9 Oct 2013. 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?
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?
Presence of persistent postsurgical pain as measured at 6 months after surgery. (time frame: five years). 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 NCT01537731, 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 9 Oct 2013.