NCT07705230

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 5, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

total knee arthroplastyAdductor canal blockgenicular nerves and femoral cutaneous nerves blocks

Outcome Measures

Primary Outcomes (1)

  • End of Analgesia Time

    Time from the end of surgery until the first Numeric Rating Scale (NRS) pain score ≥ 4.

    Within the first 24 hours after surgery.

Secondary Outcomes (6)

  • Total Morphine Consumption (mg)

    During the first 24 hours after surgery

  • Total Tramadol Consumption (mg)

    During the first 24 hours after discharge

  • Heart rate (Beat/minute)

    During the first 24 hours after surgery

  • Blood pressure (mmHg)

    During the first 24 hours after surgery

  • Patient Satisfaction Score

    At 24 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

Periarticular Infiltration Analgesia Group

ACTIVE COMPARATOR

It will be infiltrated by the surgeon before prosthesis implantation.

Procedure: Periarticular Infiltration

Triple Block Group

ACTIVE COMPARATOR

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

Procedure: Ultrasound-Guided Triple Block Technique

Interventions

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.

Periarticular Infiltration Analgesia Group

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.

Triple Block Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qassim University Medical City

Buraidah, Al-Qassim Region, Saudi Arabia

Location

Study Officials

  • OMAR S Almisnid, Anesthesia Consultant

    Department of Anesthesia, College of Medicine, Qassim University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 15, 2026

Study Start

January 1, 2025

Primary Completion

April 1, 2026

Study Completion

July 1, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations