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A Prospective Randomized Controlled Unblinded Study Comparing the Effectiveness of Single Bolus versus Continuous Infusion for Femoral Triangle Block in Unilateral Total Knee Arthroplasty

A Prospective Randomized Controlled Unblinded Study Comparing the Effectiveness of Single Bolus versus Continuous Infusion for Femoral Triangle Block in Unilateral Total Knee Arthroplasty

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250617004
Enrollment
52
Registered
2025-06-17
Start date
2025-04-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dynamic pain intensity during physical therapy in the acute postoperative period at post-operative day 1 by using the numerical rating scale (NRS) between continuous femoral triangle block (CFTB) and single-shot femoral triangle block (SFTB) in patients undergoing TKA. Femoral triangle block Total knee arthroplasty Total knee replacements Pain management

Interventions

Femoral triangle block using a bolus injection of 15 ml of 0.25% bupivacaine followed by continuous infusion of 0.1% bupivacaine at a rate of 3ml/h will be maintained for 48 hours using a continuous i
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Continuous femoral triangle block,Single bolus femoral triangle block

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients age 50 - 70 years old 2. American Society of Anesthesia (ASA) physical status I-III 3. Undergone the first time for TKA

Exclusion criteria

Exclusion criteria: 1. Patients who were refused to participate in this trial 2. Patients who contraindicated to peripheral nerve block ex. Allergic to bupivacaine, NSAIDS and dexamethasone, coagulopathy, local infection at injection area 3. Patients with renal or hepatic failure 4. History of chronic strong opioid use, and drug addiction 5. Morbid obesity (BMI >40 kg/m2) 6. Severe cognitive impairment or language problems 7. Patients who cannot ambulation, disability and status bed ridden 8. Patients who refused to pay to the postoperative continuous infusion of local anesthesia set.

Design outcomes

Primary

MeasureTime frame
Pain intensity during physical therapy in the acute postoperative period 0-48 hours postoperatively Evaluate pain score by using Numeric Rating Scale (NRS, score 0-10)

Secondary

MeasureTime frame
Post operative pain intensity at rest and movement At 6th, 12th, 24th, 36th, 48th and 72nd hours post-operation Evaluate pain score by using Numeric Rating Scale (NRS, score 0-10),Cumulative morphine consumption At 6th, 12th, 24th, 36th, 48th and 72nd hours post-operation Total morphine consumption (measured in miligrams)at 6th, 12th, 24th, 36th, 48th and 72nd hours post-operation,Range of motion (ROM) of knee extension and flexion 0-48 hours postoperatively Degrees of range of motion (ROM) of knee extension and flexion,Ability to do home exercise program for TKA rehabilitation 0-72 hr postoperatively Ability to walk on level surface with appropriate arm aid, movement ascending/descending 1 steps or more within 3 days and able to do home exercise program for TKA rehabilitation,Hospital length of stay Post operative Days of postoperative length of stay,Patient satisfaction At 2 weeks and 1 month post-operative Meusure by using patient global impression of change (PGIC) score

Countries

Thailand

Contacts

Public ContactArtid Samerchua

Faculty of Medicine, Chiang Mai University

artidsamerchua@gmail.com6653935522

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026