NCT03316118

US Guided GNB vs Saline Injection for TKA

Terminated Phase 4 Results posted Last updated 28 September 2022

What this trial tests

Phase 4 trial testing bupivacaine in Postoperative Pain in 2 participants. Terminated before completion.

Timeline

5 October 2017

Primary endpoint
21 June 2021

21 June 2021

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	2
Start date	5 October 2017
Primary completion	21 June 2021
Estimated completion	21 June 2021
Sites	1 location across United States

Drugs / interventions tested

• bupivacaine (BUPIVACAINE) — full drug profile →
• saline

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
• Nerve Block — all drugs for Nerve Block →

Sponsor

Northwestern University

Who can join

Adults 40 to 85, any sex, with Postoperative Pain or Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-operative Opioid Consumption During the Hospital Stay Primary · 36 hours after surgery

Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.

Group	Value	95% CI
Group 1	24.17	23 – 27.2

Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery Secondary · 48 hours after surgery

Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain.

Group	Value	95% CI
Group 1	3.05	2.6 – 3.5

Overall Satisfaction With Pain Control 72 Hours After Surgery Secondary · 72 hours after surgery

Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied

Group	Value	95% CI
Group 1	7	6 – 8

Length of Hospitalization Secondary · Admission to discharge from hospital

Length of hospitalization in hours from time to admission to time of discharge.

Group	Value	95% CI
Group 1	38.29	30.57 – 46

Adverse events — posted to ClinicalTrials.gov

Time frame: 72 hours after surgical procedure.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1

Serious: 0/2 (0%)

Deaths: 0/2

Group 2

Serious: 0

Deaths: 0

Other adverse events (1 terms — click to expand)

Reaction	System	Group 1	Group 2
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03316118 adverse events section.

Sponsor's own description

Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection?

Hypotheses:

The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.