Hip Fracture of Intertrochanteric TypePhase 4NCT01119209
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
A Phase 4 study testing Ropivacaine and Saline in people with Hip Fracture of Intertrochanteric Type, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture of Intertrochanteric Type
- What is being tested?
- Ropivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Jan 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Intertrochanteric hip fracture
- Fracture due to low energy trauma
- Ability to understand danish and give informed consent
- Ability to walk before trauma
- Indication for osteosynthesis
- •≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
- Informed consent
Who cannot join
- Drug or medical abuse
- Drug intolerance
- Pathological fractures
- Inflammatory arthritis
- Patient included in the study with the contralateral hip
Trial locations and contacts
1 site in 1 country.
About this study
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.
- Conditions
- Hip Fracture of Intertrochanteric Type
- Being tested
- Ropivacaine, Saline
- Keywords
- Hip fracture, intertrochanteric
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Approved by the Danish Medicines Agency
SalineDrug
Approved by the Danish Medicines Agency
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Not described Receives: Drug: Ropivacaine; Drug: Saline |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of opioids
Measured: 5 days postoperatively
Secondary outcomes (1)
Pain
Measured: 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startFeb 2008
- Primary completionJan 2011
- Study completionJan 2011
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 Hip Fracture of Intertrochanteric TypeStudies of the same condition, open and under way.
- More trials run by Odense 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Soren Overgaard, MD, DmSc, Study chair, Odense University Hospital, DK-5000 Odense C, DenmarkRune Dueholm Bech, MD, Principal investigator, Odense University Hospital, DK-5000 Odense C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119209
- Sponsor's protocol ID
- S-VF-20060072 - trochanteric
- Status last verified
- Mar 2011
- First submitted
- 4 May 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018.
PubMed 30538796
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
- ClinicalTrials.gov ID
- NCT01119209
- Acronym / sponsor ID
- S-VF-20060072 - trochanteric
- Conditions
- Hip Fracture of Intertrochanteric Type
- Keywords
- Hip fracture, intertrochanteric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 May 2010 (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.
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: Ropivacaine, Drug: Saline |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Intertrochanteric hip fracture
- Fracture due to low energy trauma
- Ability to understand danish and give informed consent
- Ability to walk before trauma
- Indication for osteosynthesis
Key exclusion criteria (5 listed)
- Drug or medical abuse
- Drug intolerance
- Pathological fractures
- Inflammatory arthritis
- Patient included in the study with the contralateral hip
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 |
|---|---|---|
| RopivacaineApproved by the Danish Medicines Agency | Drug | Ropivacaine |
| SalineApproved by the Danish Medicines Agency | Drug | Ropivacaine, Saline |
Primary outcome
Consumption of opioids
Time frame: 5 days postoperatively
1 secondary outcome
Pain
Time frame: 5 days 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 16 Mar 2011.
- Derived from this study: PubMed 30538796Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018.
Related trials for Hip Fracture of Intertrochanteric Type
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Active, not recruiting
Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis
Hip Fracture of Intertrochanteric Type, Thromboembolic Event
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.
Soren Overgaard, MD, DmSc study chair
Odense University Hospital, DK-5000 Odense C, Denmark
Rune Dueholm Bech, MD principal investigator
Odense University Hospital, DK-5000 Odense C, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Hip Fracture of Intertrochanteric Type, run by Odense 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 7 inclusion and 5 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 16 Mar 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Consumption of opioids (time frame: 5 days postoperatively). 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 NCT01119209, 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 16 Mar 2011.