Postoperative PainNCT00921908
Multihole or Epidural Catheter for Local Anesthetic in the Wound
An observational study of Postoperative Pain and Hip Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Hip Arthroplasty
- What is being tested?
- 2 mBq radioactive technetium diluted in 20 mL saline
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing total hip arthoplasty
Who may be able to join
- operation with total hip arthroplasty
Who cannot join
- allergies to drugs administered
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined.
This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Being tested
- 2 mBq radioactive technetium diluted in 20 mL saline
- Keywords
- total hip arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mBq radioactive technetium diluted in 20 mL salineOther
| Study group | Role | What they receive |
|---|---|---|
| epidural catheter | subfascial placement of a triple-orifice epidural catheter Receives: Other: 2 mBq radioactive technetium diluted in 20 mL saline | |
| multiholed catheter | subfascial placement of a multi-orifice 15 cm catheter Receives: Other: 2 mBq radioactive technetium diluted in 20 mL saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound spread area of radioactive isotope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921908
- Sponsor's protocol ID
- H-A-2008-028
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multihole or Epidural Catheter for Local Anesthetic in the Wound
- ClinicalTrials.gov ID
- NCT00921908
- Acronym / sponsor ID
- H-A-2008-028
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Keywords
- total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Jun 2009 (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.
Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined.
This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural catheter | – | Other: 2 mBq radioactive technetium diluted in 20 mL salinesubfascial placement of a triple-orifice epidural catheter |
| multiholed catheter | – | Other: 2 mBq radioactive technetium diluted in 20 mL salinesubfascial placement of a multi-orifice 15 cm catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing total hip arthoplasty
Key inclusion criteria (1 listed)
- operation with total hip arthroplasty
Key exclusion criteria (1 listed)
- allergies to drugs administered
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 |
|---|---|---|
| 2 mBq radioactive technetium diluted in 20 mL saline | Other | epidural catheter, multiholed catheter |
Primary outcome
wound spread area of radioactive isotope
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 17 Jun 2009.
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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 Postoperative Pain and Hip Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
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 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 17 Jun 2009. 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 Denmark. 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?
wound spread area of radioactive isotope. 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 17 Jun 2009.