Osteoarthritis, HipNCT02359136
Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty
A study testing local infiltration anesthesia using Ropivacaine and Epinephrine, local infiltration anesthesia using saline and Multimodal analgesic regimen in people with Osteoarthritis, Hip, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- local infiltration anesthesia using Ropivacaine and Epinephrine, local infiltration anesthesia using saline and Multimodal analgesic regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Jan 2015
- 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
- all patients receiving total hip arthroplasty in the study period
Who cannot join
- contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
- Patients who received general anaesthetic
- patients who will get a different operation than standard direct lateral surgery
- Patients with osteosynthesis to be removed in the same operation
Trial locations and contacts
1 site in 1 country.
About this study
Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified.
Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.
- Conditions
- Osteoarthritis, Hip
- Being tested
- local infiltration anesthesia using Ropivacaine and Epinephrine, local infiltration anesthesia using saline, Multimodal analgesic regimen
- Keywords
- Arthroplasty, Replacement, Hip, Anesthesia, Local, Ropivacaine, Randomized controlled trial
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration anesthesia using Ropivacaine and EpinephrineProcedure or surgery
150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.
local infiltration anesthesia using salineProcedure or surgery
150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.
Multimodal analgesic regimenProcedure or surgery
All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.
| Study group | Role | What they receive |
|---|---|---|
| LIA placebo | Placebo comparator | local infiltration anesthesia using saline i addition to multimodal analgesic regimen Receives: Procedure: local infiltration anesthesia using saline; Procedure: Multimodal analgesic regimen |
| LIA Ropivacaine | Experimental | local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen Receives: Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine; Procedure: Multimodal analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain assessed by numeric rating scale
assessed by numeric rating scale
Measured: 1 day (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 posted9 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionJan 2015
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 Osteoarthritis, HipStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tina Strømdal Wik, md phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359136
- Sponsor's protocol ID
- 2012/1999
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.
PubMed 25997827
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02359136
- Acronym / sponsor ID
- 2012/1999
- Conditions
- Osteoarthritis, Hip
- Keywords
- Arthroplasty, Replacement, Hip, Anesthesia, Local, Ropivacaine, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Feb 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.
Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified.
Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIA placebo | Placebo comparator | Procedure: local infiltration anesthesia using saline, Procedure: Multimodal analgesic regimenlocal infiltration anesthesia using saline i addition to multimodal analgesic regimen |
| LIA Ropivacaine | Experimental | Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine, Procedure: Multimodal analgesic regimenlocal infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients receiving total hip arthroplasty in the study period
Key exclusion criteria (4 listed)
- contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
- Patients who received general anaesthetic
- patients who will get a different operation than standard direct lateral surgery
- Patients with osteosynthesis to be removed in the same operation
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 |
|---|---|---|
| local infiltration anesthesia using Ropivacaine and Epinephrine150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer. | Procedure or surgery | LIA Ropivacaine |
| local infiltration anesthesia using saline150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer. | Procedure or surgery | LIA placebo |
| Multimodal analgesic regimenAll patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed. | Procedure or surgery | LIA Ropivacaine, LIA placebo |
Primary outcome
postoperative pain assessed by numeric rating scale
Time frame: 1 day (first postoperative day)
assessed by numeric rating scale
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 31 Mar 2017.
- Results publication: PubMed 25997827Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.
Related trials for Osteoarthritis, Hip
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
Tina Strømdal Wik, md phd principal investigator
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 local infiltration anesthesia using Ropivacaine and Epinephrine, local infiltration anesthesia using saline and Multimodal analgesic regimen in people with Osteoarthritis, Hip, 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 1 inclusion and 4 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 31 Mar 2017. 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?
postoperative pain assessed by numeric rating scale (time frame: 1 day (first postoperative day)). 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 NCT02359136, 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 31 Mar 2017.