Trial Outcomes & Findings for Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty? (NCT NCT02276495)

Results Overview

The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

within 24 hours postoperative

Results posted on

2024-10-29

Participant Flow

Subjects were recruited from the main operating room from January 2015 through December of 2019. Recruitment was prolonged due to PI changes secondary to personnel leaving the university.

Participant milestones

Participant milestones
Measure	Joint Infiltration Only ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB + Joint Infiltration ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Only ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
Overall Study STARTED	18	17	20
Overall Study COMPLETED	18	17	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACB Control + Local Infiltration n=18 Participants ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Study + Local Infiltration n=17 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Study Only n=20 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)	Total n=55 Participants Total of all reporting groups
Age, Continuous	65 years n=18 Participants	68 years n=17 Participants	67 years n=20 Participants	67 years n=55 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	9 Participants n=17 Participants	9 Participants n=20 Participants	29 Participants n=55 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	8 Participants n=17 Participants	11 Participants n=20 Participants	26 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 Participants n=18 Participants	17 Participants n=17 Participants	20 Participants n=20 Participants	55 Participants n=55 Participants
Height (cm)	169 centimeters n=18 Participants	167 centimeters n=17 Participants	169 centimeters n=20 Participants	169 centimeters n=55 Participants
Weight (lbs)	198 pounds n=18 Participants	207 pounds n=17 Participants	181 pounds n=20 Participants	188 pounds n=55 Participants

PRIMARY outcome

Timeframe: within 24 hours postoperative

The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.

Outcome measures

Outcome measures
Measure	Joint Infiltration Only n=18 Participants ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB + Joint Infiltration n=17 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Only n=20 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
Pain Score	5 units on a scale Interval 3.5 to 6.0	4.5 units on a scale Interval 2.0 to 5.0	4 units on a scale Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: within 24 hours postoperative

24 Hour post-surgical opioid use

Outcome measures

Outcome measures
Measure	Joint Infiltration Only n=18 Participants ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB + Joint Infiltration n=17 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Only n=20 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
Opioid Use	38 Daily mg morphine equivalents Interval 18.0 to 66.0	0 Daily mg morphine equivalents Interval 0.0 to 22.0	26 Daily mg morphine equivalents Interval 0.0 to 45.0

SECONDARY outcome

Timeframe: First 24 hours post-operative

Total distance ambulated during physical therapy during first 24 hours

Outcome measures

Outcome measures
Measure	Joint Infiltration Only n=18 Participants ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB + Joint Infiltration n=17 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)	ACB Only n=20 Participants ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
Ambulation Distance	140 feet Interval 100.0 to 360.0	350 feet Interval 225.0 to 370.0	95 feet Interval 20.0 to 160.0

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-operative day of surgery

Population: Data was incompletely collected across the study so no analysis performed

Self-reported subject anxiety prior to surgery

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperatively day of surgery

Population: Study data was incompletely collected across the study period so no analysis was performed

Baseline pain preoperatively

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Preop, PACU, and 4,8, 12, and 24 hours post-operatively.

Population: NRS scores were not collected during the study, so no analysis is performed.

A modified pain score similar to VAS but rated from 0-10

Outcome measures

Outcome data not reported

Adverse Events

Joint Infiltration Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACB + Joint Infiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACB Only

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. Joseph Rinehart

UC Irvine Health Department of Anesthesiology & Perioperative Care

Phone: 714-456-7415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place