Peripheral Nerve BlockPhase 4HOBSALIplusNCT02374008
The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.
A Phase 4 study testing Ropivacaine in people with Peripheral Nerve Block and Pain, run by Regionshospitalet Silkeborg.
Trial summary
Purpose: The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Peripheral Nerve Block, Pain
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2015
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- ASA 1-3
Who cannot join
- Patients who can not cooperate with the investigation
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients receiving glucocorticoid daily
- Patients with a treatment-dependent diabetes mellitus
Show all 11Show fewer
- Patients with known neuropathy in the lower limbs
- Allergy to those used in the study drugs
- Alcohol and / or drug abuse - the investigator's opinion
- Patients who can not tolerate NSAIDs
- Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)
About this study
Official title: The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Read more
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of two treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
- B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
- Conditions
- Peripheral Nerve Block, Pain
- Being tested
- Ropivacaine
- Keywords
- Peripheral nerve block, Total knee Arthroplasty, Dexamethasone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Adrenalin, Ketorolac, Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Combined nerve block | Experimental | Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone Receives: Drug: Ropivacaine |
| Local infiltrationanalgesia | Active comparator | Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: 0 - 20 hours postoperatively
Secondary outcomes (12)
Opioid consumption
Measured: 0 - 24 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees.
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: At timepoint 2 , 6, 20 and 24 hours postoperatively
Pain score at rest
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The highest score since last score recorded.
Measured: At timepoint 2 , 6, 20 and 24 hours postoperatively
Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
Recorded at PCA(patient-controlled-analgesia) pump
Measured: 0-24 hours postoperatively
Nausea Score
NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea. The highest score since last score recorded.
Measured: At timepoint 2, 6, 20, 24 hours postoperatively
Number of vomiting
Measured: 0- 20 hours and 0-24 hours postoperatively
Consumption of Ondansetron
Measured: 0-20 hours and 0-24 hours
Reporting of dizziness Recording whether the dizziness is preventing mobilization.
Recording whether the dizziness is preventing
Measured: at timepoint 2, 6, 20 and 24 hours postoperatively.
Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.
Measured: 0-24 hours postoperatively
Discharge time from the hospital
Measured: maximum 60 hour postoperatively.
Preoperatively isometric tests of muscle strength in the hip adductors.
Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated.
Measured: pre and 30 minutes after block placement
Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
Measured: 0-24 hours posteratively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 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 Peripheral Nerve BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Runge, Regionshospitalet Silkeborg
- Investigators
- Charlotte Runge, MD, Study director, Regionalhospital Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374008
- Sponsor's protocol ID
- 2014-003343-35
- Other IDs
- 2014
- Acronym
- HOBSALIplus
- Status last verified
- Nov 2015
- First submitted
- 22 Feb 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Runge C, Jensen JM, Clemmesen L, Knudsen HB, Holm C, Borglum J, Bendtsen TF. Analgesia of Combined Femoral Triangle and Obturator Nerve Blockade Is Superior to Local Infiltration Analgesia After Total Knee Arthroplasty With High-Dose Intravenous Dexamethasone. Reg Anesth Pain Med. 2018 May;43(4):352-356. doi: 10.1097/AAP.0000000000000731.
PubMed 29346228
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02374008
- Acronym / sponsor ID
- HOBSALIplus / 2014-003343-35
- Conditions
- Peripheral Nerve Block, Pain
- Keywords
- Peripheral nerve block, Total knee Arthroplasty, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 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.
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of two treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
- B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined nerve block | Experimental | Drug: RopivacaineRopivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone |
| Local infiltrationanalgesia | Active comparator | Drug: RopivacaineRopivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- ASA 1-3
Key exclusion criteria (11 listed)
- Patients who can not cooperate with the investigation
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients receiving glucocorticoid daily
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 |
|---|---|---|
| RopivacaineAlso: Adrenalin, Ketorolac, Dexamethasone | Drug | Combined nerve block, Local infiltrationanalgesia |
Primary outcome
Opioid consumption
Time frame: 0 - 20 hours postoperatively
12 secondary outcomes
Opioid consumption
Time frame: 0 - 24 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees.
Time frame: At timepoint 2 , 6, 20 and 24 hours postoperatively
Pain score at rest
Time frame: At timepoint 2 , 6, 20 and 24 hours postoperatively
Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
Time frame: 0-24 hours postoperatively
Nausea Score
Time frame: At timepoint 2, 6, 20, 24 hours postoperatively
Number of vomiting
Time frame: 0- 20 hours and 0-24 hours postoperatively
Consumption of Ondansetron
Time frame: 0-20 hours and 0-24 hours
Reporting of dizziness Recording whether the dizziness is preventing mobilization.
Time frame: at timepoint 2, 6, 20 and 24 hours postoperatively.
Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
Time frame: 0-24 hours postoperatively
Discharge time from the hospital
Time frame: maximum 60 hour postoperatively.
Preoperatively isometric tests of muscle strength in the hip adductors.
Time frame: pre and 30 minutes after block placement
Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
Time frame: 0-24 hours posteratively
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 30 Nov 2015.
- Derived from this study: PubMed 29346228Runge C, Jensen JM, Clemmesen L, Knudsen HB, Holm C, Borglum J, Bendtsen TF. Analgesia of Combined Femoral Triangle and Obturator Nerve Blockade Is Superior to Local Infiltration Analgesia After Total Knee Arthroplasty With High-Dose Intravenous Dexamethasone. Reg Anesth Pain Med. 2018 May;43(4):352-356. doi: 10.1097/AAP.0000000000000731.
Related trials for Peripheral Nerve Block
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Nerve Block Resolution Time Display and Pain Complaints
Postoperative Pain, Rebound Pain
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.
Charlotte Runge, MD study director
Regionalhospital Silkeborg
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Peripheral Nerve Block and Pain, run by Regionshospitalet Silkeborg.
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 11 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Opioid consumption (time frame: 0 - 20 hours 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 NCT02374008, 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 30 Nov 2015.