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CompletedNCT01706549Updated Feb 13, 2017Results posted

Clinical Analysis of Pain After Hysterectomy

An observational study in Postoperative Pain, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2017-02-13.

Sponsored by Tampere University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 69 Years
Sex
Female
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Study 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. to reveal the type of pain, neuropathic, nociceptive or idiopathic.
  3. 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.

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Conditions studied

  • Postoperative Pain

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Keywords

  • Chronic pain
  • Hysterectomy
  • Quality of life
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 16 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • hysterectomy 1-3 years previously
  • suffering from pain 6months postsurgically

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (actual)

Groups and cohorts

  • Posthysterectomy pain

    Observational study on posthysterectomy pain

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What researchers measure

Primary outcomes

  1. Type of Chronic Pain After Hysterectomy

    Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.

    Time frame: 1-3 years after hysterectomy

Secondary outcomes

  1. Quality of Life After Hysterectomy

    Quality of life as measured by the SF-36, which consists of 8 scales.

    Time frame: 1-3 years after hysterectomy

  2. Is the Pain Due to Hysterectomy?

    Number of patients having posthysterectomy pain versus other pain

    Time frame: 1-3 years

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Results

Posted Jun 2, 2015
Limitations and caveats
Low participation rate. Inadequate filling of questionnaires. Time from surgery to clinical examination varied from 10 to 44 months. No preoperative quality of life measure.

Participant flow

January 2012-December 2013. Patients recruited from previous studies. Clinical evaluation at the Hospital on the basis of volunteering.

Participant flow — Overall Study
MilestonePosthysterectomy Pain
Started16
Completed16
Not completed0

Outcome measures

PrimaryType of Chronic Pain After Hysterectomy

Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.

Time frame:
1-3 years after hysterectomy
Reported as:
Number · participants
Type of Chronic Pain After Hysterectomy
participantsPosthysterectomy Pain
Probable neuropathic pain5
Possible neuropathic pain4
Subsided pain6
Other type of pain1
SecondaryQuality of Life After Hysterectomy

Quality of life as measured by the SF-36, which consists of 8 scales.

Time frame:
1-3 years after hysterectomy

Results for this outcome have not been posted.

SecondaryIs the Pain Due to Hysterectomy?

Number of patients having posthysterectomy pain versus other pain

Time frame:
1-3 years
Reported as:
Number · participants
Is the Pain Due to Hysterectomy?
participantsPosthysterectomy Pain
Is the Pain Due to Hysterectomy?15

Adverse events

Collected over May 11th 2012-November 15th 2013. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Posthysterectomy Pain———

Baseline characteristics

Patients undergone hysterectomy and reportteri to have SUFFERED from pain 6 months postoperatively and volunteered for a clinical examination.

Age, Continuous
Age, Continuous(Years)Postoperative Pain
Mean51 ± 6.6
Age, Categorical
Age, Categorical(Participants)Postoperative Pain
<=18 years0
Between 18 and 65 years15
>=65 years1
Gender
Gender(Participants)Postoperative Pain
Female16
Male0
Region of Enrollment
Region of Enrollment(participants)Postoperative Pain
Finland16
Quality of life (SF-36)
Quality of life (SF-36)(units on a scale)Postoperative Pain
Physical Functioning76.9 ± 29.2
Role Physical57.8 ± 45.7
Role Emotional54.1 ± 43.9
Vitality55.3 ± 24.8
Mental health70.0 ± 18.2
Social Functioning70.6 ± 26.8
Bodily Pain65.5 ± 29.2
General health56.8 ± 20.1
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Study locations

1 site
  • Tampere University Hospital
    Tampere, 33200, Finland
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01706549
Lead sponsor
Tampere University Hospital
Responsible party
Sponsor
First posted
Oct 15, 2012
Start date
Mar 2012
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Jun 2, 2015
Last update
Feb 13, 2017

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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