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Total Knee AnthroplastyNCT07705230

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 study testing Periarticular Infiltration and Ultrasound-Guided Triple Block Technique in people with Total Knee Anthroplasty, run by SAMEH ELSHERBINI at 1 site in Saudi Arabia.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Total Knee Anthroplasty
What is being tested?
Periarticular Infiltration and Ultrasound-Guided Triple Block Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteSaudi Arabia
Study dates
20 Oct 2026to 1 Apr 2027
Phase
Interventional

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

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

Who cannot join

  • 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 surgery at the same knee
  • Renal impairment.
  • Patients who suffer from chronic neuropathic pain or on regular pain medications other than NSAIDs.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sameh M El-Sherbiny, MD contact

+2010065600748

Smfsherbiny@yahoo.com

Saudi Arabia1 site
  • Qassim University Medical City

    Buraidah, Al-Qassim Region

    SAMEH M ELSHERBINI, MD, 00966559125485, SELSHERBINI@QUMC.EDU.SA

Other trials in Saudi Arabia

About this study

Official title: 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.

Read more

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

Read the detailed description

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.

Being tested
Periarticular Infiltration, Ultrasound-Guided Triple Block Technique
Keywords
total knee arthroplasty, Adductor canal block, genicular nerves and femoral cutaneous nerves blocks

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periarticular InfiltrationProcedure or surgery

    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.

  • Ultrasound-Guided Triple Block TechniqueProcedure or surgery

    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.

Study groups in NCT07705230
Study groupRoleWhat they receive
Periarticular Infiltration Analgesia GroupActive comparatorIt will be infiltrated by the surgeon before prosthesis implantation.
Receives: Procedure: Periarticular Infiltration
Triple Block GroupActive comparatorPatients will receive ultrasound-guided adductor canal, infrapatellar, medial cutaneous, and superior genicular nerve blocks.
Receives: Procedure: Ultrasound-Guided Triple Block Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. End of Analgesia Time

    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

    Measured: Within the first 24 hours after surgery.

Secondary outcomes (9)
  1. Total Morphine Consumption (mg)

    Total cumulative morphine consumption during hospital stay

    Measured: From end of surgery until hospital discharge (same day, approximately 6 to 9 hours)

  2. Total Tramadol Consumption (number of capsules)

    Total tramadol consumption after hospital discharge

    Measured: From hospital discharge until the last diary entry (approximately 16 hours after arrival home)

  3. Heart rate (Beat/minute)

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

    Measured: From end of surgery until hospital discharge, assessed up to 12 hours

  4. Blood pressure (mmHg)

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

    Measured: From end of surgery until hospital discharge, assessed up to 12 hours

  5. Patient Satisfaction Score

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

    Measured: At 24 hours after the end of surgery

  6. Length of Hospital Stay

    Minutes

    Measured: From operating room admission until same-day hospital discharge, assessed up to 24 hours

  7. NRS pain score at each time point

    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

    Measured: From PACU arrival until the last home diary entry, assessed up to 24 hours

  8. Time to first ambulation

    Minutes from DSU arrival to first ambulation

    Measured: From DSU arrival until first ambulation, assessed up to 12 hours

  9. Postoperative nausea and vomiting

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705230
Sponsor's protocol ID
REGIONAL BLOCKS IN TKA
Status last verified
Oct 2026
First submitted
5 Jul 2026
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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