Osteoarthritis of the Knee or HipBLASTNCT06230081
Comparison Between Blocks or Not in Joint Arthroplasty
A study testing Ropivacain 5 mg/ml + Clonidine in people with Osteoarthritis of the Knee or Hip, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee or Hip
- What is being tested?
- Ropivacain 5 mg/ml + Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2024to 26 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee- or hip necessitating total knee- or hip replacement
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Who cannot join
- Known allergy to local anesthetics or other contraindication for the use of local anesthetics.
- Coagulopathy
- Bilateral operation
- Revision arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia in Patients Undergoing Hip and Knee Replacement Surgery - a Study Comparing Ultrasound-guided Nerve Blocks With Intraoperative Local Anesthetic Infiltration or Opioids
The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.
Read the detailed description
400 patients with osteoarthritis of the knee (200) or hip (200) necessitating total hip- or knee replacement are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. Patients are receiving general- or spinal anaesthesia during the surgery. General anaesthesia is conducted using Remifentanil 50ug/ml and Propofol 20 mg/ml utilizing a TCI protocol. The airway is managed by LMA or endotracheal tube. Spinal anaesthesia is conducted using isobaric Bupivacaine (hip) and hyperbaric bupivacaine (knee). Decision regarding type of anaesthesia is following guidelines of our department taking contraindications and patients preference into account.
Patients randomized to the block-group undergoing hip replacement surgery with posterior approach are given och combination of PENG block and Iliohypogastric block using Ropivacain 5 mg/ml with a total dose of 200 mg along with clonidine in a total dose of 75 micrograms. Patients undergoing hip replacement with lateral approach are given a combination of PENG block and LFCN block using Ropivacain 5 mg/ml with a total dose of 125 mg along with clonidine in a total dose of 56,25 micrograms. Patients randomized to the standard pain management strategy undergoing hip replacement surgery are given a combination of opioids, paracetamol and Cox-II inhibitors.
Patients randomized to the block-group undergoing knee replacement surgery are given a combination of iPACK-, genicular-, AFCN-, adductor canal and vastus intermedius block using Ropivacain 5 mg/ml with a total dose of 225 mg along with clonidine in a total dose of 75 micrograms. Patients randomized to the standard pain management strategy undergoing knee replacement surgery are given a perioperative periarticular LIA using Ropivacaine 300 mg along with 0,5 mg of adrenaline.
The randomization is executed on the day before surgery by opening of a closed numbered envelope giving information if the specific patient should have a block (intervention) or not (control). There are 200 prepared envelopes for the hip replacements and 200 for the knee replacements, with 100 blocks and 100 no blocks for each type. The envelopes are prepared by block randomization performed by computer software. Nurses and physiotherapists who evaluate postoperative pain are blinded from the intervention. The physician compiling the data from the study is also blinded to the intervention.
Preoperatively, information is collected regarding doses of analgesics and pain in everyday life is evaluated using the NRS scale. Preoperative pain is evaluated at rest and during mobilization.
Postoperatively, an evaluation of pain is made. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The registration takes place using the subjective Numeric Rating Scale (NRS) and the objective Critical-Care Pain Observation Tool (CPOT). Pain is continuously evaluated during the hospital stay. The final registration takes place at the return visit 14 days after surgery. During the hospital stay, other parameters such as opioid consumption, requirement for urinary catheter, postoperative nausea and vomiting (PONV), time to mobilization and neurological complications are also registered. The number of extra opioid doses the patient requires are also registered. The number of days the patients need to stay in hospital after surgery are registered.
- Conditions
- Osteoarthritis of the Knee or Hip
- Being tested
- Ropivacain 5 mg/ml + Clonidine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacain 5 mg/ml + ClonidineDrug
Drug used in the block
| Study group | Role | What they receive |
|---|---|---|
| Block | Active comparator | Hip Arthroplasty: Multimodal analgesic therapy + Ultrasound guided PENG block and Iliohypogastric block or LFCN-block.
Knee arthroplasty: Multimodal analgesic therapy + Ultrasound guided iPACK block, triple Genicular blocks, Vastus intermedius block, Adductor canal block and AFCN-block. Receives: Drug: Ropivacain 5 mg/ml + Clonidine |
| No block | No intervention | Hip Arthroplasty: Multimodal analgesic therapy Knee Arthroplasty: Multimodal analgesic therapy + LIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Postoperative pain assessed by NRS
Patient experienced postop pain assessed by NRS (0-10)
Measured: The day of surgery, postop day 1 and 14 days post-surgery
Secondary outcomes (8)
Difference in analgesia consumption
Difference in extra oral- and intravenous analgesia consumption (tablets or injections - in mg)
Measured: The day of surgery, postop day 1 and 14 days post-surgery
Time to mobilization
Difference in time mobilizing to standing after surgery
Measured: The day of surgery, postop day 1
Incidence of postoperative nausea and vomiting
Difference in postoperative nausea and vomiting (reported frequency)
Measured: The day of surgery, postop day 1
Difference in postoperative pain depending on method of anesthesia
Difference in postoperative pain depending on method of anesthesia, i.e. General- or Spinal anesthesia. Assessed by NRS (0-10)
Measured: The day of surgery, postop day 1 and 14 days post-surgery
urine catheter usage
Difference in frequency of urine catheter usage
Measured: 1-5 days post-surgery
neurological complications
Difference in frequency of neurological complications (reported to and assessed by physiotherapist)
Measured: The day of surgery, postop day 1 and 14 days post-surgery
Days in hospital
Number of postoperative days in hospital
Measured: 1-5 days post-surgery
opioid consumption 14 days
Difference in opioid consumption 14 days after surgery
Measured: 14 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024
- Primary completion30 Mar 2025
- Study completion26 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the Knee or HipStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients are randomized to either block or no block therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Flivik, MD PhD, Principal investigator, Department of Orthopedics, Skane Univ Hosp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230081
- Sponsor's protocol ID
- BLAST study
- Acronym
- BLAST
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: General unidentified data and study protocol are available on request
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Patients Undergoing Hip and Knee Replacement Surgery - a Study Comparing Ultrasound-guided Nerve Blocks With Intraoperative Local Anesthetic Infiltration or Opioids
- ClinicalTrials.gov ID
- NCT06230081
- Acronym / sponsor ID
- BLAST / BLAST study
- Conditions
- Osteoarthritis of the Knee or Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 26 Apr 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- 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.
The purpose of this study is to evaluate the effect on postoperative pain, opioid consumption and function by adding a combination of regional blocks with local anaesthetic before total hip- and knee arthroplasty compared to standard pain management strategies.
Detailed description
400 patients with osteoarthritis of the knee (200) or hip (200) necessitating total hip- or knee replacement are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. Patients are receiving general- or spinal anaesthesia during the surgery. General anaesthesia is conducted using Remifentanil 50ug/ml and Propofol 20 mg/ml utilizing a TCI protocol. The airway is managed by LMA or endotracheal tube. Spinal anaesthesia is conducted using isobaric Bupivacaine (hip) and hyperbaric bupivacaine (knee). Decision regarding type of anaesthesia is following guidelines of our department taking contraindications and patients preference into account.
Patients randomized to the block-group undergoing hip replacement surgery with posterior approach are given och combination of PENG block and Iliohypogastric block using Ropivacain 5 mg/ml with a total dose of 200 mg along with clonidine in a total dose of 75 micrograms. Patients undergoing hip replacement with lateral approach are given a combination of PENG block and LFCN block using Ropivacain 5 mg/ml with a total dose of 125 mg along with clonidine in a total dose of 56,25 micrograms. Patients randomized to the standard pain management strategy undergoing hip replacement surgery are given a combination of opioids, paracetamol and Cox-II inhibitors.
Patients randomized to the block-group undergoing knee replacement surgery are given a combination of iPACK-, genicular-, AFCN-, adductor canal and vastus intermedius block using Ropivacain 5 mg/ml with a total dose of 225 mg along with clonidine in a total dose of 75 micrograms. Patients randomized to the standard pain management strategy undergoing knee replacement surgery are given a perioperative periarticular LIA using Ropivacaine 300 mg along with 0,5 mg of adrenaline.
The randomization is executed on the day before surgery by opening of a closed numbered envelope giving information if the specific patient should have a block (intervention) or not (control). There are 200 prepared envelopes for the hip replacements and 200 for the knee replacements, with 100 blocks and 100 no blocks for each type. The envelopes are prepared by block randomization performed by computer software. Nurses and physiotherapists who evaluate postoperative pain are blinded from the intervention. The physician compiling the data from the study is also blinded to the intervention.
Preoperatively, information is collected regarding doses of analgesics and pain in everyday life is evaluated using the NRS scale. Preoperative pain is evaluated at rest and during mobilization.
Postoperatively, an evaluation of pain is made. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The registration takes place using the subjective Numeric Rating Scale (NRS) and the objective Critical-Care Pain Observation Tool (CPOT). Pain is continuously evaluated during the hospital stay. The final registration takes place at the return visit 14 days after surgery. During the hospital stay, other parameters such as opioid consumption, requirement for urinary catheter, postoperative nausea and vomiting (PONV), time to mobilization and neurological complications are also registered. The number of extra opioid doses the patient requires are also registered. The number of days the patients need to stay in hospital after surgery are registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients are randomized to either block or no block therapy
| Arm | Type | Receives |
|---|---|---|
| Block | Active comparator | Drug: Ropivacain 5 mg/ml + ClonidineHip Arthroplasty: Multimodal analgesic therapy + Ultrasound guided PENG block and Iliohypogastric block or LFCN-block. Knee arthroplasty: Multimodal analgesic therapy + Ultrasound guided iPACK block, triple Genicular blocks, Vastus intermedius block, Adductor canal block and AFCN-block. |
| No block | No intervention | –Hip Arthroplasty: Multimodal analgesic therapy Knee Arthroplasty: Multimodal analgesic therapy + LIA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Osteoarthritis of the knee- or hip necessitating total knee- or hip replacement
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Key exclusion criteria (4 listed)
- Known allergy to local anesthetics or other contraindication for the use of local anesthetics.
- Coagulopathy
- Bilateral operation
- Revision arthroplasty
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 |
|---|---|---|
| Ropivacain 5 mg/ml + ClonidineDrug used in the block | Drug | Block |
Primary outcome
Difference in Postoperative pain assessed by NRS
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Patient experienced postop pain assessed by NRS (0-10)
8 secondary outcomes
Difference in analgesia consumption
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Time to mobilization
Time frame: The day of surgery, postop day 1
Incidence of postoperative nausea and vomiting
Time frame: The day of surgery, postop day 1
Difference in postoperative pain depending on method of anesthesia
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
urine catheter usage
Time frame: 1-5 days post-surgery
neurological complications
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Days in hospital
Time frame: 1-5 days post-surgery
opioid consumption 14 days
Time frame: 14 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. General unidentified data and study protocol are available on request
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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.
Gunnar Flivik, MD PhD principal investigator
Department of Orthopedics, Skane Univ Hosp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacain 5 mg/ml + Clonidine in people with Osteoarthritis of the Knee or Hip, run by Region Skane at 1 site in Sweden.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in Postoperative pain assessed by NRS (time frame: The day of surgery, postop day 1 and 14 days post-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 28 Apr 2026.