Femoral Neck FracturesNCT02585011
Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
A study testing Ropivacaine, Epinephrine and Saline in people with Femoral Neck Fractures, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Ropivacaine, Epinephrine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2015to 13 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled for hemiarthroplasty at St. Olavs Hospital
- competent and willing to give consent
- able to be mobilized in the PACU and in the trauma ward unit.
Who cannot join
- contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene
- receiving general anesthesia
- patients operated on with an approach different to standard direct lateral surgery
- receiving osteosyntheses
- receiving femoral block less than 4 hours before surgery
Trial locations and contacts
1 site in 1 country.
About this study
At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.
- Conditions
- Femoral Neck Fractures
- Being tested
- Ropivacaine, Epinephrine, Saline
- Keywords
- Hemiarthroplasty, Anesthesia, Local, Pain, Postoperative
- Medical subject headings
- Femoral Neck Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
EpinephrineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml) Receives: Drug: Ropivacaine; Drug: Epinephrine |
| Placebo | Placebo comparator | Single shot during surgery.150 ml saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation during mobilization in the post-anesthesia care unit.
Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?
Measured: 24 hours (day of surgery)
Secondary outcomes (2)
Pain during mobilization on the day after surgery
Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?
Measured: 48 hours (first postoperative day)
Total consumption of opioids on the first postoperative day
Measured: 48 hrs (first postoperative day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion13 May 2018
- Study completion13 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by St. Olavs 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Olav Foss, Phd, Study director, Ortopedisk forskningssenter, St.Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585011
- Sponsor's protocol ID
- 2015/1201
- Status last verified
- Sep 2020
- First submitted
- 14 Oct 2015
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
- ClinicalTrials.gov ID
- NCT02585011
- Acronym / sponsor ID
- 2015/1201
- Conditions
- Femoral Neck Fractures
- Keywords
- Hemiarthroplasty, Anesthesia, Local, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Dec 2015 (actual)
- Primary completion
- 13 May 2018 (actual)
- Study completion
- 13 May 2018 (actual)
- First posted
- 23 Oct 2015 (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.
At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.
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 | Experimental | Drug: Ropivacaine, Drug: EpinephrineLocal infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml) |
| Placebo | Placebo comparator | Drug: SalineSingle shot during surgery.150 ml saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for hemiarthroplasty at St. Olavs Hospital
- competent and willing to give consent
- able to be mobilized in the PACU and in the trauma ward unit.
Key exclusion criteria (5 listed)
- contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene
- receiving general anesthesia
- patients operated on with an approach different to standard direct lateral surgery
- receiving osteosyntheses
- receiving femoral block less than 4 hours before surgery
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 |
|---|---|---|
| Ropivacaine | Drug | Ropivacaine |
| Epinephrine | Drug | Ropivacaine |
| Saline | Drug | Placebo |
Primary outcome
Pain sensation during mobilization in the post-anesthesia care unit.
Time frame: 24 hours (day of surgery)
Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?
2 secondary outcomes
Pain during mobilization on the day after surgery
Time frame: 48 hours (first postoperative day)
Total consumption of opioids on the first postoperative day
Time frame: 48 hrs (first postoperative day)
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 11 Sep 2020.
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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.
Olav Foss, Phd study director
Ortopedisk forskningssenter, St.Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine, Epinephrine and Saline in people with Femoral Neck Fractures, run by St. Olavs Hospital at 1 site in Norway.
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 3 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 11 Sep 2020. 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 Norway. 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.
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?
Pain sensation during mobilization in the post-anesthesia care unit. (time frame: 24 hours (day of surgery)). 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 11 Sep 2020.