Postoperative AnalgesiaNCT01916473
Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia
A study testing Epidural analgesia and Continuous wound infusion in people with Postoperative Analgesia, run by University of Athens at 1 site in Greece.
Trial summary
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Epidural analgesia and Continuous wound infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Nov 2012
- Phase
- Interventional
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -
Who cannot join
- Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.
Read the detailed description
The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.
- Conditions
- Postoperative Analgesia
- Being tested
- Epidural analgesia, Continuous wound infusion
- Keywords
- Epidural analgesia, continuous wound infusion, ropivacaine, total abdominal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaOther
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Continuous wound infusionOther
Continuous wound infusion via catheter
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Active comparator | Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly Receives: Other: Epidural analgesia |
| Continuous wound infusion | Experimental | The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour. Receives: Other: Continuous wound infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Measured: 2 hours postoperatively
Postoperative morphine consumption
Measured: 4 hours postoperatively
Postoperative morphine consumption
Measured: 8 hours postoperatively
Postoperative morphine consumption
Measured: 24 hours postoperatively
Postoperative morphine consumption
Measured: 48 hours postoperatively
Postoperative morphine consumption
Measured: 72 hours postoperatively
Postoperative morphine consumption
Measured: 3 months postoperatively
Postoperative morphine consumption
Measured: 6 months postoperatively
Secondary outcomes (8)
pain scores
Measured: 2 hours postoperatively
pain scores
Measured: 4 hours postoperatively
pain scores
Measured: 8 hours postoperatively
pain scores
Measured: 24 hours postoperatively
pain scores
Measured: 48 hours postoperatively
pain scores
Measured: 72 hours postoperatively
pain scores
Measured: 3 months postoperatively
pain scores
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startApr 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyro Fassoulaki, University of Athens
- Investigators
- Argyro Fassoulaki, MD,PhD, DEAA, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916473
- Sponsor's protocol ID
- M-20/23-02-2010
- Status last verified
- Aug 2013
- First submitted
- 15 Jul 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01916473
- Acronym / sponsor ID
- M-20/23-02-2010
- Conditions
- Postoperative Analgesia
- Keywords
- Epidural analgesia, continuous wound infusion, ropivacaine, total abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Aug 2013 (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.
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.
Detailed description
The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Active comparator | Other: Epidural analgesiaEpidural analgesia is provided with ropvacaine 0.2% given 6 hourly |
| Continuous wound infusion | Experimental | Other: Continuous wound infusionThe continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -
Key exclusion criteria (2 listed)
- Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes
- -
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 |
|---|---|---|
| Epidural analgesiaEpidural analgesia is provided with ropvacaine 0.2% given 6 hourly | Other | Epidural analgesia |
| Continuous wound infusionContinuous wound infusion via catheter | Other | Continuous wound infusion |
Primary outcome
Postoperative morphine consumption
Time frame: 2 hours postoperatively
Postoperative morphine consumption
Time frame: 4 hours postoperatively
Postoperative morphine consumption
Time frame: 8 hours postoperatively
Postoperative morphine consumption
Time frame: 24 hours postoperatively
Postoperative morphine consumption
Time frame: 48 hours postoperatively
Postoperative morphine consumption
Time frame: 72 hours postoperatively
Postoperative morphine consumption
Time frame: 3 months postoperatively
Postoperative morphine consumption
Time frame: 6 months postoperatively
8 secondary outcomes
pain scores
Time frame: 2 hours postoperatively
pain scores
Time frame: 4 hours postoperatively
pain scores
Time frame: 8 hours postoperatively
pain scores
Time frame: 24 hours postoperatively
pain scores
Time frame: 48 hours postoperatively
pain scores
Time frame: 72 hours postoperatively
pain scores
Time frame: 3 months postoperatively
pain scores
Time frame: 6 months postoperatively
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 5 Aug 2013.
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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.
Argyro Fassoulaki, MD,PhD, DEAA principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia and Continuous wound infusion in people with Postoperative Analgesia, run by University of Athens at 1 site in Greece.
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 2 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 5 Aug 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 Greece. 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?
Postoperative morphine consumption (time frame: 2 hours postoperatively). The study lists 8 primary outcomes in all. 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 5 Aug 2013.