- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07705230
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
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Al-Qassim Region
-
Buraidah, Al-Qassim Region, Saudi-Arabien
- Qassim University Medical City
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- ASA: I & II
- Gender: Male & Female
- Age: 18and above
- BMI less than 40 kg/m2
- Patients are scheduled for primary unilateral total knee arthroplasty.
Exclusion Criteria:
- Patients with contraindications to spinal anesthesia
- Failed spinal anesthesia.
- ASA III-IV
- Body mass index (BMI)≥40,
- A known allergy or contraindication to the drugs used in this study.
- Previous knee surgery.
- Renal impairment.
- Patients who suffer from chronic neuropathic pain or on regular pain medications other than NSAIDs.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Periarticular Infiltration Analgesia Group
It will be infiltrated by the surgeon before prosthesis implantation.
|
A total volume of 60 mL containing bupivacaine, ketorolac, adrenaline, and tranexamic acid will be infiltrated by the surgeon before prosthesis implantation into the posterior capsule, medial and lateral gutters, quadriceps mechanism, patellar tendon, and medial periosteum.
|
|
Aktiver 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 infrapatellar and medial cutaneous nerve blocks, and 10 mL each for the superior medial and superior lateral genicular nerve blocks.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
End of Analgesia Time
Zeitfenster: Within the first 24 hours after surgery.
|
Time from the end of surgery until the first Numeric Rating Scale (NRS) pain score ≥ 4.
|
Within the first 24 hours after surgery.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total Morphine Consumption (mg)
Zeitfenster: During the first 24 hours after surgery
|
Total cumulative morphine consumption during hospital stay
|
During the first 24 hours after surgery
|
|
Total Tramadol Consumption (mg)
Zeitfenster: During the first 24 hours after discharge
|
Total tramadol consumption after hospital discharge
|
During the first 24 hours after discharge
|
|
Heart rate (Beat/minute)
Zeitfenster: During the first 24 hours after surgery
|
Heart rate measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.
|
During the first 24 hours after surgery
|
|
Blood pressure (mmHg)
Zeitfenster: During the first 24 hours after surgery
|
Blood pressure measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.
|
During the first 24 hours after surgery
|
|
Patient Satisfaction Score
Zeitfenster: At 24 hours after surgery
|
Patient satisfaction with postoperative analgesia assessed using a five-point Likert scale (range: 1 to 5), where 1 indicates very dissatisfied and 5 indicates very satisfied.
|
At 24 hours after surgery
|
|
Length of Hospital Stay
Zeitfenster: During the index hospitalization up to 3 days postoperatively
|
Duration from operating room admission until hospital discharge.
|
During the index hospitalization up to 3 days postoperatively
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: OMAR S Almisnid, Anesthesia Consultant, Department of Anesthesia, College of Medicine, Qassim University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- REGIONAL BLOCKS IN TKA
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .