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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
Saudi Arabia1 site
Qassim University Medical City
Buraidah, Al-Qassim Region
SAMEH M ELSHERBINI, MD, 00966559125485, SELSHERBINI@QUMC.EDU.SA
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.
- Conditions
- Total Knee Anthroplasty
- 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 group | Role | What they receive |
|---|---|---|
| Periarticular Infiltration Analgesia Group | Active comparator | It will be infiltrated by the surgeon before prosthesis implantation. Receives: Procedure: Periarticular Infiltration |
| Triple Block Group | Active comparator | Patients 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.
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)
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)
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)
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
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
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
Length of Hospital Stay
Minutes
Measured: From operating room admission until same-day hospital discharge, assessed up to 24 hours
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
Time to first ambulation
Minutes from DSU arrival to first ambulation
Measured: From DSU arrival until first ambulation, assessed up to 12 hours
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.
- First posted15 Jul 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAMEH ELSHERBINI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SAMEH ELSHERBINI, Qassim University
- Investigators
- OMAR S Almisnid, Anesthesia Consultant, Principal investigator, Department of Anesthesia, College of Medicine, Qassim University
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