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Combination of Nerve Blocks and Local Infiltration Analgesia in Knee Arthroplasty

ConditionOsteo Arthritis of the Knee
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnancy

Coagulopathy or other bleeding disorder that precludes regional anesthesia

Allergy to local anesthetics

Inability to understand spoken and written Swedish

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacain 5 mg/ml + Clonidine

    Drug

    Drug used in the block

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention Arm-Nerve blocks in addition to Local Infiltration AnalgesiaActive comparator 1 intervention
Group B: Control arm - Local Infiltration Analgesia onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity: Measured using the NRS scale 0-10 at multiple predefined time points postoperatively (1 hour, 4 hours, 24 hours)

Pain intensity was assessed using the Numeric Rating Scale (NRS) upon arrival at the post anesthesia care unit (PACU) and at 1, 2, 3 and 4 hours post-PACU admission, as well as at ward admission, on the evening of the surgery day, the morning of Postoperative Day 1 (POD1), and at discharge. At the post-surgery visit at 14 days NRS was also assessed.

Time frame
The day of surgery, postop day 1 and 14 days post-surgery
2

Difference in analgesia consumption

Total Postoperative Opioid Consumption: Cumulative morphine equivalents (mg) recorded during hospitalization (intraoperative and postoperative period).

Time frame
The day of surgery, postop day 1 and 14 days post-surgery

Secondary outcomes

1

Time to mobilization

Time to First Mobilization: Time (hours) from arrival to the PACU to first mobilization (sitting, standing, or walking as tolerated)

Time frame
The day of surgery, postop day 1
2

Incidence of postoperative nausea and vomiting

Postoperative Nausea and vomiting: Incidence and severity recorded via patient report and use of antiemetic medication

Time frame
The day of surgery, postop day 1
3

Neurological complications

Difference in frequency of neurological complications between groups: sensory deficits (paresthesia, numbness, hypoesthesia) and motor impairment (weakness, difficulty in muscular contraction) reported to and assessed by physiotherapist.

Time frame
The day of surgery, postop day 1 and at day 14 post-surgery. Patients that report or shows neurological complications at the post surgery visit day 14 will be followed up once more, 6 month after surgery.
4

Length of Hospital Stay

Number of postoperative days in hospital.

Time frame
1-5 days post-surgery

Other outcomes

Sponsors and contacts

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

Region Skane

Lead sponsor

Greta and Johan Kock Foundation

Collaborator

Source ClinicalTrials.gov
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