Comparative study between two groups of patients who underwent ultrasound-guided peripheral nerve blocks to improve postoperative pain in the knee arthroplasty

Comparative study between two ultrasound-guided peripheral blocks for postoperative analgesia of primary total knee arthroplasty

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005443-23-ES

Enrollment

Registered

2021-07-05

Start date

2021-06-21

Completion date

Unknown

Last updated

2021-07-12

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

Conditions

Patients undergoing knee replacement

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The included patients will undergo unilateral primary total knee arthroplasty, aged between 50 and 80 years, ASA I-III, BMI =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Those patients with indication for primary total knee arthrosplasty with decompensated systemic diseases (hyperthyroidism, severe peripheral vascular disease, diabetics ...), prosthetic replacement surgeries, uncontrolled psychiatric disorders, denial or contraindication to intradural regional anesthesia and peripheral, with a previous history of adverse effects and / or allergy to local anesthetics, NSAIDs, metamizole or tramadol.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To compare the analgesic quality between two groups of patients who underwent bicompartmental unilateral total knee arthroplasty at Hospital Sant Joan de Reus, who will undergo a femoral block, associated or not with a tibial block at the popliteal level whit ropivacaine;Secondary Objective: As secondary objectives: 2) Evaluate start of rehabilitation. 3) Quantify hospital stay. 4) Evaluate the postoperative clinical and functional complications. 5) Evaluate patient satisfaction. 6) Evaluate opiate use.;Primary end point(s): -Analgesic evaluation according to the EN scale (numerical scale: 0-10);Timepoint(s) of evaluation of this end point: -Analgesic evaluation according to the EN scale (numerical scale: 0-10) in the immediate postoperative period, upon discharge from the URPA (postanesthetic recovery unit), 6-12-24-36 and at 48 hours, at rest and in motion, considering mild pain less than or equal to 3, moderate from 4 to 6 and severe greater than 7.	—

Measure

Time frame

Main Objective: 1) To compare the analgesic quality between two groups of patients who underwent bicompartmental unilateral total knee arthroplasty at Hospital Sant Joan de Reus, who will undergo a femoral block, associated or not with a tibial block at the popliteal level whit ropivacaine;Secondary Objective: As secondary objectives: 2) Evaluate start of rehabilitation. 3) Quantify hospital stay. 4) Evaluate the postoperative clinical and functional complications. 5) Evaluate patient satisfaction. 6) Evaluate opiate use.;Primary end point(s): -Analgesic evaluation according to the EN scale (numerical scale: 0-10);Timepoint(s) of evaluation of this end point: -Analgesic evaluation according to the EN scale (numerical scale: 0-10) in the immediate postoperative period, upon discharge from the URPA (postanesthetic recovery unit), 6-12-24-36 and at 48 hours, at rest and in motion, considering mild pain less than or equal to 3, moderate from 4 to 6 and severe greater than 7.

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Secondary

Measure	Time frame
Secondary end point(s): - Demographic: age, sex and BMI (weight and height). - ASA (I-III). - Assessment of functionality in basic activities: preoperative Barthel index. - Surgical time in minutes. - Ischemia time in minutes. - Type of knee prosthesis. - Assessment of motor and sensitive block in URPA. Reversion time. - Consumption of postoperative analgesia in the first 48h. - Time elapsed until the first rescue analgesic. - Postoperative pharmacological and technical complications and side effects. - Rehabilitation start at 24h. - Assessment of risk of falling: Tinetti scale at 24 hours after surgery and before discharge. - Days of hospital stay. - Overall patient satisfaction at discharge: very satisfied, acceptable or dissatisfied. - Would you repeat the technique performed? YES/NO;Timepoint(s) of evaluation of this end point: Patient control during the first 48 postoperative hours	—

Measure

Time frame

Secondary end point(s): - Demographic: age, sex and BMI (weight and height). - ASA (I-III). - Assessment of functionality in basic activities: preoperative Barthel index. - Surgical time in minutes. - Ischemia time in minutes. - Type of knee prosthesis. - Assessment of motor and sensitive block in URPA. Reversion time. - Consumption of postoperative analgesia in the first 48h. - Time elapsed until the first rescue analgesic. - Postoperative pharmacological and technical complications and side effects. - Rehabilitation start at 24h. - Assessment of risk of falling: Tinetti scale at 24 hours after surgery and before discharge. - Days of hospital stay. - Overall patient satisfaction at discharge: very satisfied, acceptable or dissatisfied. - Would you repeat the technique performed? YES/NO;Timepoint(s) of evaluation of this end point: Patient control during the first 48 postoperative hours

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Countries

Spain

Contacts

Public ContactServicio Anestesiología

Hospital Sant Joan de Reus

a.mira.puerto@gmail.com+34977310300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026