Osteo Arthritis of the KneePhase 4BALIANCT07350252
Combination of Nerve Blocks and Local Infiltration Analgesia in Knee Arthroplasty
A Phase 4 study testing Ropivacain 5 mg/ml + Clonidine in people with Osteo Arthritis of the Knee, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- Ropivacain 5 mg/ml + Clonidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 5 Mar 2026to 1 Sep 2027
- Phase
- Phase 4
- 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
- -Undergoing primary unilateral total knee arthroplasty
Who cannot join
- Pregnancy
- Coagulopathy or other bleeding disorder that precludes regional anesthesia
- Allergy to local anesthetics
- Inability to understand spoken and written Swedish
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Trelleborg Hospital
Trelleborg
About this study
Official title: Postoperative Analgesia in Patients Undergoing Knee Replacement Surgery - a Study Comparing Intraoperative Local Infiltration Analgesia Only With Ultrasound-guided Nerve Blocks Added to Intraoperative Local Infiltration Analgesia, a Randomized Clinical Trial
The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.
Read the detailed description
Scientific Rationale and Background Total Knee Arthroplasty (TKA) requires effective perioperative pain management. Traditionally, Local Infiltration Analgesia (LIA)has been the standard method, sometimes combined with femoral nerve block. However, femoral nerve block impairs quadriceps motor function, making early mobilization-critical for postoperative rehabilitation-difficult for participants.
Recent advances have introduced purely sensory nerve block techniques that preserve motor function. The knee joint innervation is complex and involves multiple neural pathways. The Saphenous Nerve (SN), Nervus Vastus Medialis (NVM), and the Anterior Femoral Cutaneous Nerve (AFCN) are all branches of the femoral nerve that provide sensory innervation to the knee without contributing to motor control of the quadriceps. The adductor canal contains the SN and NVM, which are primarily sensory nerves. The AFCN travels superficially in the femoral triangle and innervates the skin of the anterior and medial thigh.
Studies have shown that adductor canal block (targeting SN and NVM) combined with LIA provides comparable pain relief to femoral nerve block without motor impairment. Additionally, the AFCN contributes to sensory innervation of the anterolateral and anteromedial aspects of the knee joint. Our hypothesis is that combining these three sensory blocks (SN, NVM, and AFCN) with LIA may provide superior pain control and reduced opioid consumption compared to LIA alone, while preserving motor function necessary for early mobilization.
Primary Research Questions
- Does the combination of the SN block, the NVM block of and the AFCN block togheter with LIA provide better postoperative pain control compared to LIA alone?
- Does the above combination reduce total postoperative opioid consumption? Secondary Research Questions
<!-- -->
- Does the nerve block combination facilitate earlier postoperative mobilization?
- Does it reduce the incidence of postoperative nausea and vomiting?
- What is the incidence of neurological complications (sensory deficits and motor impairment)?
- Does the intervention affect length of hospital stay?
Randomization and Allocation Procedure Randomization is conducted the day before surgery by the responsible anesthesiologist using a computer-generated randomization sequence. The anesthesiologist draws a sealed randomization envelope containing the group allocation. The envelope accompanies the patient's medical record and case report forms (CRFs ) throughout the hospital stay and is verified in the operating room by the anesthesiologist.
Anesthesia type (general anesthesia with propofol and remifentanil using TCI (Target Controlled Infusion) with Eleveld pharmacokinetic model, or spinal anesthesia with 0.5% bupivacaine) is determined by clinical indication and is independent of randomization.
Arms and Interventions All patients receive standardized multimodal analgesia preoperatively: etoricoxib, paracetamol, oxycodone, and betamethasone.
Intervention Arm: Nervus Vastus Medialis (NVM) block + Saphenous Nerve (SN) block + Anterior Femoral Cutaneous Nerve (AFCN) block + Local Infilration Analgesia (LIA) All nerve blocks are performed under ultrasound guidance with strict sterile precautions.
- NVM block:
- In-plane ultrasound approach using a linear high-frequency transducer
- Needle inserted from the lateral thigh, placed between vastus medialis and sartorius, lateral to the adductor membrane
- Injection: 5 ml ropivacaine 5% with clonidine 1.875 micrograms per ml
- NVM is visualized and surrounded by local anesthetic
- SN block:
- Same needle entry point as NVM block
- Needle retracted and advanced toward the lateral border of the femoral artery
- Sartorius posterior fascia is perforated; needle tip placed beside the SN
- Injection: 10 ml ropivacaine 0.5% with clonidine 1.875 micrograms per ml
- Hydrodissection of the adductor canal is observed; SN is completely surrounded by local anesthetic
- AFCN block:
- AFCN divides into multiple branches at the level of the femoral triangle
- Nerves are located superficially above the superior sartorius fascia in loose subcutaneous fascia
- Typically, 3-4 individual nerve branches are visualized
- Needle retracted in-plane from the adductor canal approach
- Individual branches blocked superficially above sartorius
- Injection: 1 ml ropivacaine 5% with clonidine 1.875 micrograms per ml per branch
- LIA:
- LIA is administered by the surgeon before wound closure
- 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously Control Arm: LIA Only
- LIA is administered by the surgeon before wound closure
- 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously Enrollment Planned Total Enrollment: 200 patients Principal Investigators:
- Fredrik Fellert, MD, DESA, EDIC, EDEC, PhD student, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
- Andreas Ekman, MD, PhD, DEAA, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
- Fredrik Sjövall, MD, Associate Professor, Senior Consultant, Department of Perioperative and Intensive Care, Malmö University Hospital, Lund University, Sweden
- Gunnar Flivik, MD, Associate Professor, Senior Consultant, Department of Orthopedics, Lund university Hospital, Lund University, Sweden Ethical Approval Ethics Committee: Swedish Ethical Review Authority (Etikprövningsmyndigheten) Approval Reference: 2025-06626-01 Approval Date: 2025-10-30 This study is conducted in accordance with the Declaration of Helsinki and applicable Swedish regulations for clinical research, including the Act on Ethical Review of Research Involving Humans (2003:460). Statistical Considerations: A priori sample size calculation was performed using a two-sample t test with a significance level (alpha) of 0.05 and statistical power of 0.80, assuming a between-group difference of 2 points on the NRS pain scale. This yielded an estimated requirement of 90 participants per group to achieve adequate power. Data will be analyzed using SPSS. Descriptive statistics will be presented as appropriate for the distribution of each variable. Group comparisons will be performed using chi-square test or Fisher's exact test for categorical variables, and independent-samples t test or Mann-Whitney U test for continuous variables, depending on assessment of normality.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- Ropivacain 5 mg/ml + Clonidine
- Keywords
- Treatment
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 |
|---|---|---|
| Intervention Arm-Nerve blocks in addition to Local Infiltration Analgesia | Active comparator | Ultrasound guided nerve blocks are administered preoperatively in addition to the Local Infiltration Analgesia administered during surgery.
Nerve blocks used:
1. Nerve to Vastus Medialis (NVM) block:
Injection: 5 ml ropivacaine 5% with clonidine 1.875 micrograms per ml
2. Saphenous Nerve (SN) block:
Injection: 10 ml ropivacaine 0.5% with clonidine 1.875 micrograms per ml
3. Anterior Femoral Cutaneous Nerve (AFCN) Block:
AFCN divides into multiple branches at the level of the femoral triangle Injection: 1 ml ropivacaine 5% with clonidine 1.875 micrograms per ml per branch
Local Infiltration Analgesia (LIA):
150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously Receives: Drug: Ropivacain 5 mg/ml + Clonidine |
| Control arm - Local Infiltration Analgesia only | No intervention | No ultrasound guided nerve blocks are administered. Local Infiltration Analgesia (LIA) is the same as in the- intervention arm: 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity: Measured using the NRS scale 0-10 at multiple predefined time points postoperatively (1 hour, 4 hours, 24 hours)
Pain intensity was assessed using the Numeric Rating Scale (NRS) upon arrival at the post anesthesia care unit (PACU) and at 1, 2, 3 and 4 hours post-PACU admission, as well as at ward admission, on the evening of the surgery day, the morning of Postoperative Day 1 (POD1), and at discharge. At the post-surgery visit at 14 days NRS was also assessed.
Measured: The day of surgery, postop day 1 and 14 days post-surgery
Difference in analgesia consumption
Total Postoperative Opioid Consumption: Cumulative morphine equivalents (mg) recorded during hospitalization (intraoperative and postoperative period).
Measured: The day of surgery, postop day 1 and 14 days post-surgery
Secondary outcomes (5)
Time to mobilization
Time to First Mobilization: Time (hours) from arrival to the PACU to first mobilization (sitting, standing, or walking as tolerated)
Measured: The day of surgery, postop day 1
Incidence of postoperative nausea and vomiting
Postoperative Nausea and vomiting: Incidence and severity recorded via patient report and use of antiemetic medication
Measured: The day of surgery, postop day 1
Neurological complications
Difference in frequency of neurological complications between groups: sensory deficits (paresthesia, numbness, hypoesthesia) and motor impairment (weakness, difficulty in muscular contraction) reported to and assessed by physiotherapist.
Measured: The day of surgery, postop day 1 and at day 14 post-surgery. Patients that report or shows neurological complications at the post surgery visit day 14 will be followed up once more, 6 month after surgery.
Length of Hospital Stay
Number of postoperative days in hospital.
Measured: 1-5 days post-surgery
Difference in postoperative pain depending on method of anesthesia
Exploratory analysis by anesthesia type: Comparison of pain scores (assessed by NRS (0-10)) and opioid consumption (equivalents in mg) between patients receiving general anesthesia versus spinal anesthesia
Measured: The day of surgery, postop day 1 and 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 posted20 Jan 2026
- Study start5 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Model description
- Randomized Controlled Trial Number of Arms: 2 parallel arms Allocation Ratio: 1:1 randomization using computer-generated sequence Blinding: Outcome assessor blinded; staff registering NRS pain scores and opioid consumption are blinded to group allocation. No sham block is used in the control group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Greta and Johan Kock Foundation
- Responsible party
- Sponsor
- Investigators
- Andreas Ekman, MD, PhD, Principal investigator, VO Planned Operations, Trelleborg Hospital, and Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350252
- Sponsor's protocol ID
- 2025-06626-01
- Other IDs
- 2025
- Acronym
- BALIA
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be de-identified; each patient receives a unique enrollment number. De-identified study data will be stored in an Excel spreadsheet secured behind Lund University's institutional firewall. Data will not be shared publicly. Access to anonymized datasets may be considered upon reasonable request to the principal investigators, subject to GDPR compliance and institutional review approval. Data Availability: Results and findings will be published in peer-reviewed journals and may be presented at scientific conferences. Individual patient data will remain confidential and protected in accordance with applicable data protection regulations.
Publications
Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Nyengaard JR, Bendtsen TF. The anterior branch of the medial femoral cutaneous nerve innervates the anterior knee: a randomized volunteer trial. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):643-652. doi: 10.23736/S0375-9393.22.16910-5. Epub 2023 Feb 27.
PubMed 36852567Riegler G, Pivec C, Jengojan S, Mayer JA, Schellen C, Trattnig S, Bodner G. Cutaneous nerve fields of the anteromedial lower limb-Determination with selective ultrasound-guided nerve blockade. Clin Anat. 2021 Jan;34(1):11-18. doi: 10.1002/ca.23582. Epub 2020 Feb 29.
PubMed 32065687Luo ZY, Yu QP, Zeng WN, Xiao Q, Chen X, Wang HY, Zhou Z. Adductor canal block combined with local infiltration analgesia with morphine and betamethasone show superior analgesic effect than local infiltration analgesia alone for total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2022 May 19;23(1):468. doi: 10.1186/s12891-022-05388-5.
PubMed 35590308Mingdeng X, Yuzhang A, Xiaoxiao X, Yucheng A, Xin W, Dianming J. Combined application of adductor canal block and local infiltration anesthesia in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2022 Jun;142(6):913-926. doi: 10.1007/s00402-020-03706-x. Epub 2021 Jan 8.
PubMed 33417022Schnabel A, Reichl SU, Weibel S, Zahn PK, Kranke P, Pogatzki-Zahn E, Meyer-Friessem CH. Adductor canal blocks for postoperative pain treatment in adults undergoing knee surgery. Cochrane Database Syst Rev. 2019 Oct 26;2019(10):CD012262. doi: 10.1002/14651858.CD012262.pub2.
PubMed 31684698Berikashvili LB, Yadgarov MY, Kuzovlev AN, Smirnova AV, Kadantseva KK, Kuznetsov IV, Polyakov PA, Likhvantsev VV. Adductor Canal Block Versus Femoral Nerve Block in Total Knee Arthroplasty: Network Meta-Analysis. Clin J Pain. 2024 Jul 1;40(7):447-457. doi: 10.1097/AJP.0000000000001214.
PubMed 38561898Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.
PubMed 36042669Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721.
PubMed 28079176Peng XQ, Fei ZG, Sun CG, Zhou QJ. Efficacy and safety of local infiltration analgesia for pain management in total knee and hip arthroplasty: A meta-analysis of randomized controlled trial. Medicine (Baltimore). 2020 May 29;99(22):e20640. doi: 10.1097/MD.0000000000020640.
PubMed 32481477Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220.
PubMed 24996539
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Patients Undergoing Knee Replacement Surgery - a Study Comparing Intraoperative Local Infiltration Analgesia Only With Ultrasound-guided Nerve Blocks Added to Intraoperative Local Infiltration Analgesia, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07350252
- Acronym / sponsor ID
- BALIA / 2025-06626-01
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Greta and Johan Kock Foundation
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 Jan 2026 (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 aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.
Detailed description
Scientific Rationale and Background Total Knee Arthroplasty (TKA) requires effective perioperative pain management. Traditionally, Local Infiltration Analgesia (LIA)has been the standard method, sometimes combined with femoral nerve block. However, femoral nerve block impairs quadriceps motor function, making early mobilization-critical for postoperative rehabilitation-difficult for participants.
Recent advances have introduced purely sensory nerve block techniques that preserve motor function. The knee joint innervation is complex and involves multiple neural pathways. The Saphenous Nerve (SN), Nervus Vastus Medialis (NVM), and the Anterior Femoral Cutaneous Nerve (AFCN) are all branches of the femoral nerve that provide sensory innervation to the knee without contributing to motor control of the quadriceps. The adductor canal contains the SN and NVM, which are primarily sensory nerves. The AFCN travels superficially in the femoral triangle and innervates the skin of the anterior and medial thigh.
Studies have shown that adductor canal block (targeting SN and NVM) combined with LIA provides comparable pain relief to femoral nerve block without motor impairment. Additionally, the AFCN contributes to sensory innervation of the anterolateral and anteromedial aspects of the knee joint. Our hypothesis is that combining these three sensory blocks (SN, NVM, and AFCN) with LIA may provide superior pain control and reduced opioid consumption compared to LIA alone, while preserving motor function necessary for early mobilization.
Primary Research Questions
- Does the combination of the SN block, the NVM block of and the AFCN block togheter with LIA provide better postoperative pain control compared to LIA alone?
- Does the above combination reduce total postoperative opioid consumption? Secondary Research Questions
<!-- -->
- Does the nerve block combination facilitate earlier postoperative mobilization?
- Does it reduce the incidence of postoperative nausea and vomiting?
- What is the incidence of neurological complications (sensory deficits and motor impairment)?
- Does the intervention affect length of hospital stay?
Randomization and Allocation Procedure Randomization is conducted the day before surgery by the responsible anesthesiologist using a computer-generated randomization sequence. The anesthesiologist draws a sealed randomization envelope containing the group allocation. The envelope accompanies the patient's medical record and case report forms (CRFs ) throughout the hospital stay and is verified in the operating room by the anesthesiologist.
Anesthesia type (general anesthesia with propofol and remifentanil using TCI (Target Controlled Infusion) with Eleveld pharmacokinetic model, or spinal anesthesia with 0.5% bupivacaine) is determined by clinical indication and is independent of randomization.
Arms and Interventions All patients receive standardized multimodal analgesia preoperatively: etoricoxib, paracetamol, oxycodone, and betamethasone.
Intervention Arm: Nervus Vastus Medialis (NVM) block + Saphenous Nerve (SN) block + Anterior Femoral Cutaneous Nerve (AFCN) block + Local Infilration Analgesia (LIA) All nerve blocks are performed under ultrasound guidance with strict sterile precautions.
- NVM block:
- In-plane ultrasound approach using a linear high-frequency transducer
- Needle inserted from the lateral thigh, placed between vastus medialis and sartorius, lateral to the adductor membrane
- Injection: 5 ml ropivacaine 5% with clonidine 1.875 micrograms per ml
- NVM is visualized and surrounded by local anesthetic
- SN block:
- Same needle entry point as NVM block
- Needle retracted and advanced toward the lateral border of the femoral artery
- Sartorius posterior fascia is perforated; needle tip placed beside the SN
- Injection: 10 ml ropivacaine 0.5% with clonidine 1.875 micrograms per ml
- Hydrodissection of the adductor canal is observed; SN is completely surrounded by local anesthetic
- AFCN block:
- AFCN divides into multiple branches at the level of the femoral triangle
- Nerves are located superficially above the superior sartorius fascia in loose subcutaneous fascia
- Typically, 3-4 individual nerve branches are visualized
- Needle retracted in-plane from the adductor canal approach
- Individual branches blocked superficially above sartorius
- Injection: 1 ml ropivacaine 5% with clonidine 1.875 micrograms per ml per branch
- LIA:
- LIA is administered by the surgeon before wound closure
- 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously Control Arm: LIA Only
- LIA is administered by the surgeon before wound closure
- 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously Enrollment Planned Total Enrollment: 200 patients Principal Investigators:
- Fredrik Fellert, MD, DESA, EDIC, EDEC, PhD student, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
- Andreas Ekman, MD, PhD, DEAA, Senior Consultant, VO Planned Operations, Trelleborg Hospital, Lund University, Sweden
- Fredrik Sjövall, MD, Associate Professor, Senior Consultant, Department of Perioperative and Intensive Care, Malmö University Hospital, Lund University, Sweden
- Gunnar Flivik, MD, Associate Professor, Senior Consultant, Department of Orthopedics, Lund university Hospital, Lund University, Sweden Ethical Approval Ethics Committee: Swedish Ethical Review Authority (Etikprövningsmyndigheten) Approval Reference: 2025-06626-01 Approval Date: 2025-10-30 This study is conducted in accordance with the Declaration of Helsinki and applicable Swedish regulations for clinical research, including the Act on Ethical Review of Research Involving Humans (2003:460). Statistical Considerations: A priori sample size calculation was performed using a two-sample t test with a significance level (alpha) of 0.05 and statistical power of 0.80, assuming a between-group difference of 2 points on the NRS pain scale. This yielded an estimated requirement of 90 participants per group to achieve adequate power. Data will be analyzed using SPSS. Descriptive statistics will be presented as appropriate for the distribution of each variable. Group comparisons will be performed using chi-square test or Fisher's exact test for categorical variables, and independent-samples t test or Mann-Whitney U test for continuous variables, depending on assessment of normality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial Number of Arms: 2 parallel arms Allocation Ratio: 1:1 randomization using computer-generated sequence Blinding: Outcome assessor blinded; staff registering NRS pain scores and opioid consumption are blinded to group allocation. No sham block is used in the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm-Nerve blocks in addition to Local Infiltration Analgesia | Active comparator | Drug: Ropivacain 5 mg/ml + ClonidineUltrasound guided nerve blocks are administered preoperatively in addition to the Local Infiltration Analgesia administered during surgery. Nerve blocks used: 1. Nerve to Vastus Medialis (NVM) block: Injection: 5 ml ropivacaine 5% with clonidine 1.875 micrograms per ml 2. Saphenous Nerve (SN) block: Injection: 10 ml ropivacaine 0.5% with clonidine 1.875 micrograms per ml 3. Anterior Femoral Cutaneous Nerve (AFCN) Block: AFCN divides into multiple branches at the level of the femoral triangle Injection: 1 ml ropivacaine 5% with clonidine 1.875 micrograms per ml per branch Local Infiltration Analgesia (LIA): 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously |
| Control arm - Local Infiltration Analgesia only | No intervention | –No ultrasound guided nerve blocks are administered. Local Infiltration Analgesia (LIA) is the same as in the- intervention arm: 150 ml ropivacaine 2 mg/ml with 0.5 mg adrenaline is infiltrated periarticular around the knee capsule, collateral ligaments, under the patella, and subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Undergoing primary unilateral total knee arthroplasty
Key exclusion criteria (5 listed)
- Pregnancy
- Coagulopathy or other bleeding disorder that precludes regional anesthesia
- Allergy to local anesthetics
- Inability to understand spoken and written Swedish
- Unwillingness to participate in the study
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 | Intervention Arm-Nerve blocks in addition to Local Infiltration Analgesia |
Primary outcome
Postoperative Pain Intensity: Measured using the NRS scale 0-10 at multiple predefined time points postoperatively (1 hour, 4 hours, 24 hours)
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Pain intensity was assessed using the Numeric Rating Scale (NRS) upon arrival at the post anesthesia care unit (PACU) and at 1, 2, 3 and 4 hours post-PACU admission, as well as at ward admission, on the evening of the surgery day, the morning of Postoperative Day 1 (POD1), and at discharge. At the post-surgery visit at 14 days NRS was also assessed.
Difference in analgesia consumption
Time frame: The day of surgery, postop day 1 and 14 days post-surgery
Total Postoperative Opioid Consumption: Cumulative morphine equivalents (mg) recorded during hospitalization (intraoperative and postoperative period).
5 secondary outcomes
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
Neurological complications
Time frame: The day of surgery, postop day 1 and at day 14 post-surgery. Patients that report or shows neurological complications at the post surgery visit day 14 will be followed up once more, 6 month after surgery.
Length of Hospital Stay
Time frame: 1-5 days post-surgery
Difference in postoperative pain depending on method of anesthesia
Time frame: The day of surgery, postop day 1 and 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 8 May 2026.
- Background: PubMed 36852567Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Nyengaard JR, Bendtsen TF. The anterior branch of the medial femoral cutaneous nerve innervates the anterior knee: a randomized volunteer trial. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):643-652. doi: 10.23736/S0375-9393.22.16910-5. Epub 2023 Feb 27.
- Background: PubMed 32065687Riegler G, Pivec C, Jengojan S, Mayer JA, Schellen C, Trattnig S, Bodner G. Cutaneous nerve fields of the anteromedial lower limb-Determination with selective ultrasound-guided nerve blockade. Clin Anat. 2021 Jan;34(1):11-18. doi: 10.1002/ca.23582. Epub 2020 Feb 29.
- Background: PubMed 35590308Luo ZY, Yu QP, Zeng WN, Xiao Q, Chen X, Wang HY, Zhou Z. Adductor canal block combined with local infiltration analgesia with morphine and betamethasone show superior analgesic effect than local infiltration analgesia alone for total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2022 May 19;23(1):468. doi: 10.1186/s12891-022-05388-5.
- Background: PubMed 33417022Mingdeng X, Yuzhang A, Xiaoxiao X, Yucheng A, Xin W, Dianming J. Combined application of adductor canal block and local infiltration anesthesia in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2022 Jun;142(6):913-926. doi: 10.1007/s00402-020-03706-x. Epub 2021 Jan 8.
- Background: PubMed 31684698Schnabel A, Reichl SU, Weibel S, Zahn PK, Kranke P, Pogatzki-Zahn E, Meyer-Friessem CH. Adductor canal blocks for postoperative pain treatment in adults undergoing knee surgery. Cochrane Database Syst Rev. 2019 Oct 26;2019(10):CD012262. doi: 10.1002/14651858.CD012262.pub2.
- Background: PubMed 38561898Berikashvili LB, Yadgarov MY, Kuzovlev AN, Smirnova AV, Kadantseva KK, Kuznetsov IV, Polyakov PA, Likhvantsev VV. Adductor Canal Block Versus Femoral Nerve Block in Total Knee Arthroplasty: Network Meta-Analysis. Clin J Pain. 2024 Jul 1;40(7):447-457. doi: 10.1097/AJP.0000000000001214.
- Background: PubMed 36042669Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.
- Background: PubMed 28079176Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721.
- Background: PubMed 32481477Peng XQ, Fei ZG, Sun CG, Zhou QJ. Efficacy and safety of local infiltration analgesia for pain management in total knee and hip arthroplasty: A meta-analysis of randomized controlled trial. Medicine (Baltimore). 2020 May 29;99(22):e20640. doi: 10.1097/MD.0000000000020640.
- Background: PubMed 24996539Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220.
- Individual participant dataSharing planned: No. Individual participant data will be de-identified; each patient receives a unique enrollment number. De-identified study data will be stored in an Excel spreadsheet secured behind Lund University's institutional firewall. Data will not be shared publicly. Access to anonymized datasets may be considered upon reasonable request to the principal investigators, subject to GDPR compliance and institutional review approval. Data Availability: Results and findings will be published in peer-reviewed journals and may be presented at scientific conferences. Individual patient data will remain confidential and protected in accordance with applicable data protection regulations.
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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.
Andreas Ekman, MD, PhD principal investigator
VO Planned Operations, Trelleborg Hospital, and Lund University, Sweden
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 Ropivacain 5 mg/ml + Clonidine in people with Osteo Arthritis of the Knee, 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 1 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: looking for participants now, as of the sponsor's last update on 8 May 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.
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?
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?
Contact Fredrik Fellert, MD (+46736552249, fredrik.fellert@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity: Measured using the NRS scale 0-10 at multiple predefined time points postoperatively (1 hour, 4 hours, 24 hours) (time frame: The day of surgery, postop day 1 and 14 days post-surgery). The study lists 2 primary outcomes in all. 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 NCT07350252, which also lists 10 linked publications.
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 8 May 2026.