Health TrialsbyHealthPanel

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

ConditionsTotal Knee AnthroplastyRegional Anesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSan Giovanni di Dio Hospital

About this trial

The goal of this observational study is to learn about the analgesic efficacy and postoperative recovery of two locoregional anesthesia combinations in patients \> 18 years (ASA I-III), scheduled for unilateral TKA under spinal anesthesia with expected hospitalization \> 24 hours:

* ACB + sacral ESP block * ACB + iPACK block

The main question it aims to answer is: Does the ACB + sacral ESP block combination produce effective postoperative recovery and analgesic effect?

Participants already taking ACB + sacral ESP block as part of their regular peri-operative care for TKA will be followed in the postoperative period for 48 hours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults >18 years

ASA I-III

scheduled for unilateral TKA with expected hospitalization > 24 hours

Disqualifiers

Refusal of consent

Local anesthetics allergies

contraindications to spinal or regional anesthesia

coagulation disorders

Trial population

Adults \>18 years scheduled for unilateral TKA

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Local Anesthetic Injection

    Procedure/Surgery

    combination of regional blocks for TKA postoperative analgesia

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: ACB/iPACK1 intervention
Group B: ACB/sacral ESP1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery (QoR-15) score at 24 hours post-surgery

Quality of Recovery (QoR-15) - score range 0-150 - higher scores indicate better recovery

Time frame
at 24 hours post-surgery

Secondary outcomes

1

Postoperative pain scores (NRS) at rest and movement (0-48 hours)

NRS at rest and movement - score range 0 (no pain) - 10 (the worst pain)

Time frame
0-48 hours from surgery
2

Time to first mobilization

first patient mobilization - time (hour) of first mobilization

Time frame
0-48 hours
3

Analgesic consumption (total drug dosage)

Effectiveness of the blocks

Time frame
0-48 hours
4

Time to first analgesic request (time - hour - of first request)

Duration of the blocks

Time frame
0-48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Giovanni di Dio Hospital

Lead sponsor

Source ClinicalTrials.gov
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