Combination of Nerve Blocks and Local Infiltration Analgesia in Knee Arthroplasty

NCT07350252 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-06626-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Osteo Arthritis of the Knee

Keywords

Treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  The day of surgery, postop day 1 and 14 days post-surgery

Secondary Outcomes (5)

• Time to mobilization

  The day of surgery, postop day 1

• Incidence of postoperative nausea and vomiting

  The day of surgery, postop day 1

• Neurological complications

  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

  1-5 days post-surgery

• Difference in postoperative pain depending on method of anesthesia

  The day of surgery, postop day 1 and 14 days post-surgery

Study Arms (2)

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

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

Interventions

Ropivacain 5 mg/ml + Clonidine DRUG

Drug used in the block

Intervention Arm-Nerve blocks in addition to Local Infiltration Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing primary unilateral total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Greta and Johan Kock Foundation: collaborator

Study Sites (1)

Department of Anaesthesiology, Trelleborg Hospital

Trelleborg, Sweden

Location

Related Publications (10)

• 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.

  PMID: 36852567 BACKGROUND

• Riegler 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.

  PMID: 32065687 BACKGROUND

• Luo 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.

  PMID: 35590308 BACKGROUND

• Mingdeng 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.

  PMID: 33417022 BACKGROUND

• Schnabel 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.

  PMID: 31684698 BACKGROUND

• Berikashvili 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.

  PMID: 38561898 BACKGROUND

• Hasabo 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.

  PMID: 36042669 BACKGROUND

• Wang 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.

  PMID: 28079176 BACKGROUND

• Peng 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.

  PMID: 32481477 BACKGROUND

• Marques 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.

  PMID: 24996539 BACKGROUND

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andreas Ekman, MD, PhD

  VO Planned Operations, Trelleborg Hospital, and Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Fellert, MD

CONTACT

+46736552249; fredrik.fellert@med.lu.se

Andreas Ekman, MD, PhD

CONTACT

+46702542552; andreas.ekman@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)