Health TrialsbyHealthPanel

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

ConditionsTotal Knee ReplacementKnee Arthroplasty
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.

This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Disqualifiers

Refusal of consent

Pregnancy

Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine-Liposomal Bupivacaine

    Drug

    A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.

  • Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

    Drug

    A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: B-LB in left knee and B-DEX-MPA in right kneeExperimental treatment 2 interventions
Group B: B-LB in right knee and B-DEX-MPA in left kneeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Postoperative Knee Pain Score

Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

Time frame
Day 1 and Day 2
2

Postoperative opioid consumption

In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time

Time frame
From anesthesia end time to discharge time, up to 48 hours

Secondary outcomes

1

Average Postoperative Knee Pain Score

Average postoperative knee pain scores for each surgical knee for postoperative day 7 using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

Time frame
Day 7
2

Worst and best pain score

Worst and best postoperative knee pain scores for each surgical knee for days 1, 2 and 7 using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

Time frame
Day 1, Day 2 and Day 7
3

Change in functional pain using Brief Pain Inventory (BPI)

Compare functional pain using the BPI at baseline, 6 weeks and 3 months. The BPI scale defines pain as follows: Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.

Time frame
baseline, 6 weeks and 3 months
4

Change in neuropathic pain using PainDetect

Compare neuropathic pain at baseline, 6 weeks and 3 months using PainDetect: a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.

Time frame
baseline, 6 weeks and 3 months

Other outcomes

Sponsors and contacts

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

Yale University

Lead sponsor

Department of Anesthesiology Faculty Development Fund

Collaborator

Source ClinicalTrials.gov
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