NCT02730728

Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA

Completed NA Results posted Last updated 31 October 2018

What this trial tests

NA trial testing 20ml bolus of 0.5% ropivicaine in Total Knee Arthroplasty in 159 participants. Completed in 1 January 2017.

Timeline

1 November 2015

Primary endpoint
30 June 2016

1 January 2017

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	159
Start date	1 November 2015
Primary completion	30 June 2016
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

• 20ml bolus of 0.5% ropivicaine — full drug profile →
• 0.2% Ropivicaine at 8 milliliter/hour — full drug profile →
• 5ml bolus of 0.5% ropivicaine — full drug profile →

Conditions studied

• Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
• Osteoarthritis — all drugs for Osteoarthritis →
• Post Operative Pain Control — all drugs for Post Operative Pain Control →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Total Knee Arthroplasty or Osteoarthritis. 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.

Patients With Severe Pain at 48 Hours After Surgery Primary · 48 hours

The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day

Group	Value	95% CI
Single Shot Adductor Canal Block	21
24 Hour Continuous Adductor Canal Block	14
48 Hour Continuous Adductor Canal Block	12

Pain Scores at 48 Hours After Surgery Secondary · 48 hours

Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale

Group	Value	95% CI
Single Shot Adductor Canal Block	5	± 2
24 Hour Continuous Adductor Canal Block	4.3	± 2.5
48 Hour Continuous Adductor Canal Block	3.9	± 2.4

Functional Recovery After Surgery Secondary · 48 hours

Cumulative ambulation distance in the second postoperative day measured in feet

Group	Value	95% CI
Single Shot Adductor Canal Block	155	62 – 240
24 Hour Continuous Adductor Canal Block	150	70 – 240
48 Hour Continuous Adductor Canal Block	200	90 – 270

Patient-oriented Outcomes Secondary · 48 hours

Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers

Group	Value	95% CI
Single Shot Adductor Canal Block	12	11 – 14
24 Hour Continuous Adductor Canal Block	13	11 – 15
48 Hour Continuous Adductor Canal Block	13	12 – 15

Sponsor's own description

The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.