Trial Outcomes & Findings for Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA (NCT NCT02730728)

NCT ID: NCT02730728

Last Updated: 2018-10-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 159 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2018-10-31

Participant Flow

Participant milestones

Measure	Single Shot Adductor Canal Block adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Overall Study STARTED	53	53	53
Overall Study COMPLETED	53	51	52
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Measure	Single Shot Adductor Canal Block adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Overall Study Withdrawal by Subject	0	1	0
Overall Study Lack of Efficacy	0	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Single Shot Adductor Canal Block n=53 Participants adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block n=51 Participants adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block n=52 Participants adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	Total n=156 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	66.5 years STANDARD_DEVIATION 8.5 • n=7 Participants	62.2 years STANDARD_DEVIATION 8.7 • n=5 Participants	64 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	29 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Single Shot Adductor Canal Block n=53 Participants adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block n=51 Participants adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block n=52 Participants adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Patients With Severe Pain at 48 Hours After Surgery	21 percentage of patients with severe pain	14 percentage of patients with severe pain	12 percentage of patients with severe pain

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Single Shot Adductor Canal Block n=53 Participants adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block n=51 Participants adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block n=52 Participants adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Pain Scores at 48 Hours After Surgery	5 units on a scale ( Pain score) Standard Deviation 2	4.3 units on a scale ( Pain score) Standard Deviation 2.5	3.9 units on a scale ( Pain score) Standard Deviation 2.4

SECONDARY outcome

Timeframe: 48 hours

Population: cumulative ambulation distance in second day after surgery

Cumulative ambulation distance in the second postoperative day measured in feet

Outcome measures

Measure	Single Shot Adductor Canal Block n=53 Participants adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block n=51 Participants adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block n=52 Participants adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Functional Recovery After Surgery	155 Feet Interval 62.0 to 240.0	150 Feet Interval 70.0 to 240.0	200 Feet Interval 90.0 to 270.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Single Shot Adductor Canal Block n=53 Participants adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic	24 Hour Continuous Adductor Canal Block n=51 Participants adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic	48 Hour Continuous Adductor Canal Block n=52 Participants adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic
Patient-oriented Outcomes	12 units on a scale ( QoR score) Interval 11.0 to 14.0	13 units on a scale ( QoR score) Interval 11.0 to 15.0	13 units on a scale ( QoR score) Interval 12.0 to 15.0

Adverse Events

Single Shot Adductor Canal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

24 Hour Continuous Adductor Canal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

48 Hour Continuous Adductor Canal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nabil Elkassabany

University of Pennsylvania

Phone: 2156628000

Email: nabil.elkassabany@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place