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Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty

10 listopada 2026 zaktualizowane przez: SAMEH ELSHERBINI

Analgesic Efficacy of Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty: A Prospective Randomized Trial

Background:

Pain management in total knee arthroplasty continues to evolve especially as an early postoperative analgesia is of paramount importance in achieving patient satisfaction and improving clinical outcomes. The goal of achieving an ideal analgesia modality which facilitates early rehabilitation, prevents knee stiffness, reduces hospital stay due to pain, and promotes good functional outcomes continues to be elusive. Multimodal analgesia has been devised to control postoperative pain and reduce opioid consumption including periarticular injection and peripheral nerve blocks.

Rationale:

Assess the efficacy of a triple block including Adductor canal block, superior lateral, superior medial genicular nerves block and anterior femoral cutaneous nerves block in comparison with Periarticular infiltration for pain management in patients undergoing a total knee arthroplasty.

Methods:

Prospective Randomized Control Trial

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Pain management after total knee arthroplasty continues to evolve, as effective early postoperative analgesia is essential for patient satisfaction, early mobilization, improved functional outcomes, and reduced hospital stay. Multimodal analgesia strategies have been developed to optimize pain control while minimizing opioid consumption, including periarticular injection and peripheral nerve blocks.

Femoral nerve block has traditionally been used for analgesia after total knee arthroplasty; however, its associated quadriceps weakness may delay mobilization and increase the risk of falls. Consequently, the adductor canal block has gained popularity because it provides predominantly sensory blockade while preserving quadriceps muscle strength.

The sensory innervation of the knee joint is complex and involves branches from the femoral, tibial, common peroneal, saphenous, and obturator nerves. Genicular nerve blocks specifically target the sensory innervation of the knee capsule and have emerged as a promising technique for postoperative pain management. In this study, higher volumes of local anesthetic will be used for the superior genicular nerve blocks to improve coverage of the posterior knee capsule, while the inferolateral genicular nerve block will be avoided because of the potential risk of motor weakness and foot drop.

As the medial parapatellar approach is the most common surgical approach for total knee arthroplasty, the anterior femoral cutaneous nerve, which supplies the anteromedial aspect of the distal thigh and knee, may represent an additional target for postoperative analgesia.

Periarticular injection is a surgeon-administered analgesic technique that provides effective early postoperative pain relief without affecting quadriceps strength and has become widely adopted in total knee arthroplasty.

The aim of this study is to compare the analgesic efficacy of a combined approach using adductor canal block, superior genicular nerve blocks, and anterior femoral cutaneous nerve block with periarticular injection in patients undergoing total knee arthroplasty. We hypothesize that adding superior genicular nerve blocks and anterior femoral cutaneous nerve block to adductor canal block will provide superior postoperative analgesia compared with periarticular injection.

A prospective randomized blinded trial will be conducted at Qassim University Hospital after obtaining written informed consent. Adult patients undergoing primary unilateral total knee replacement, aged above 18 years, with a body mass index below 40 kg/m² and American Society of Anesthesiologists physical status I-II will be included. Patients with contraindications to spinal anesthesia, allergy to study medications, opioid dependence, previous knee surgery, chronic neuropathic pain, or regular use of analgesics other than nonsteroidal anti-inflammatory drugs will be excluded.

All patients will undergo routine preoperative assessment and laboratory investigations. In the operating room, standard monitoring will be applied, intravenous access established, and crystalloid infusion commenced.

Spinal anesthesia will be performed under aseptic conditions using hyperbaric bupivacaine, followed by intravenous sedation with midazolam, fentanyl, and propofol infusion. All patients will receive prophylactic antibiotics and tranexamic acid, with supplemental oxygen and capnography monitoring throughout the procedure.

All surgeries will be performed using a standardized surgical technique by the same surgical team, while regional anesthesia procedures will be performed by the same anesthesiologists. Outcome assessors and data analysts will remain blinded to group allocation.

Postoperative analgesia will include regular paracetamol and ketorolac, with intravenous morphine provided as rescue analgesia when required. After discharge, patients will receive oral paracetamol and celecoxib, with tramadol and antiemetics prescribed as needed.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

112

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Al-Qassim Region
      • Buraidah, Al-Qassim Region, Arabia Saudyjska
        • Rekrutacyjny
        • Qassim University Medical City
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. ASA: I - II
  2. Gender: Male & Female
  3. Age: 18and above
  4. BMI less than 40 kg/m2
  5. Patients are scheduled for primary unilateral total knee arthroplasty.

Exclusion Criteria:

  1. Patients with contraindications to spinal anesthesia
  2. Failed spinal anesthesia.
  3. ASA III - IV
  4. Body mass index (BMI)≥40,
  5. A known allergy or contraindication to the drugs used in this study.
  6. Previous surgery at the same knee
  7. Renal impairment.
  8. Patients who suffer from chronic neuropathic pain or on regular pain medications other than NSAIDs.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Periarticular Infiltration Analgesia Group

It will be infiltrated by the surgeon before prosthesis implantation.

A total volume of 50 mL containing 49 mL bupivacaine 0.25% and dexamethasone 8 mg will be infiltrated by the surgeon before prosthesis implantation into the posterior capsule, medial and lateral gutters, quadriceps mechanism, patellar tendon, and medial periosteum.

Aktywny komparator: Triple Block Group

Patients will receive ultrasound-guided adductor canal, infrapatellar, medial cutaneous, and superior genicular nerve blocks.

Patients will receive a mixture of 45 mL of 0.25% bupivacaine and 8 mg dexamethasone. A total of 15 mL will be injected into the adductor canal, 10 mL for the anterior femoral cutaneous nerve blocks, and 10 mL each for the superior medial and superior lateral genicular nerve blocks.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
End of Analgesia Time
Ramy czasowe: Within the first 24 hours after surgery.

Time from spinal anesthesia until the first Numeric Rating Scale (NRS) pain score ≥ 4. Analysed as time-to-event using Kaplan-Meier curves and the log-rank test (Cox regression if needed). Patients without pain (NRS ≥4) by 24 hours are censored at 24 hours

Within the first 24 hours after surgery.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Total Morphine Consumption (mg)
Ramy czasowe: From end of surgery until hospital discharge (same day, approximately 6 to 9 hours)

Total cumulative morphine consumption during hospital stay

From end of surgery until hospital discharge (same day, approximately 6 to 9 hours)
Total Tramadol Consumption (number of capsules)
Ramy czasowe: From hospital discharge until the last diary entry (approximately 16 hours after arrival home)

Total tramadol consumption after hospital discharge

From hospital discharge until the last diary entry (approximately 16 hours after arrival home)
Heart rate (Beat/minute)
Ramy czasowe: From end of surgery until hospital discharge, assessed up to 12 hours

Heart rate measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.

From end of surgery until hospital discharge, assessed up to 12 hours
Blood pressure (mmHg)
Ramy czasowe: From end of surgery until hospital discharge, assessed up to 12 hours

Blood pressure measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.

From end of surgery until hospital discharge, assessed up to 12 hours
Patient Satisfaction Score
Ramy czasowe: At 24 hours after the end of surgery

Patient satisfaction with postoperative analgesia rated on a numeric scale from 0 (completely dissatisfied) to 10 (completely satisfied), obtained by telephone call.

At 24 hours after the end of surgery
Length of Hospital Stay
Ramy czasowe: From operating room admission until same-day hospital discharge, assessed up to 24 hours

Minutes

From operating room admission until same-day hospital discharge, assessed up to 24 hours
NRS pain score at each time point
Ramy czasowe: From PACU arrival until the last home diary entry, assessed up to 24 hours

NRS (0-10) recorded at PACU arrival, 30, 60, 90 and 120 min, then at DSU arrival and hourly until discharge, and at set intervals in the home diary

From PACU arrival until the last home diary entry, assessed up to 24 hours
Time to first ambulation
Ramy czasowe: From DSU arrival until first ambulation, assessed up to 12 hours

Minutes from DSU arrival to first ambulation

From DSU arrival until first ambulation, assessed up to 12 hours
Postoperative nausea and vomiting
Ramy czasowe: From PACU arrival until hospital discharge, assessed up to 12 hours

Incidence of PONV and antiemetic use (number of episodes and dose)

From PACU arrival until hospital discharge, assessed up to 12 hours

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: OMAR S Almisnid, Anesthesia Consultant, Department of Anesthesia, College of Medicine, Qassim University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 października 2026

Zakończenie podstawowe (Szacowany)

30 marca 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

5 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lipca 2026

Pierwszy wysłany (Rzeczywisty)

15 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • REGIONAL BLOCKS IN TKA

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .