Trial Outcomes & Findings for Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty (NCT NCT02798835)
NCT ID: NCT02798835
Last Updated: 2020-09-04
Results Overview
Post-operative analgesia at 24 hours
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
24 hours (Day 1)
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
Adductor Canal Block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Adductor Canal Block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8.9 • n=60 Participants
|
64.6 years
STANDARD_DEVIATION 9.1 • n=60 Participants
|
65.6 years
STANDARD_DEVIATION 7.7 • n=57 Participants
|
NA years
STANDARD_DEVIATION NA • n=177 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=60 Participants
|
42 Participants
n=60 Participants
|
33 Participants
n=57 Participants
|
112 Participants
n=177 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=60 Participants
|
18 Participants
n=60 Participants
|
24 Participants
n=57 Participants
|
65 Participants
n=177 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
31.3 kg/m^2
STANDARD_DEVIATION 5.8 • n=60 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.1 • n=60 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 5 • n=57 Participants
|
NA kg/m^2
STANDARD_DEVIATION NA • n=177 Participants
|
PRIMARY outcome
Timeframe: 24 hours (Day 1)Post-operative analgesia at 24 hours
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Cumulative 24 Hour Oral Morphine Equivalent Consumption
|
111.8 mg
Interval 79.5 to 150.0
|
118 mg
Interval 69.0 to 155.8
|
153 mg
Interval 100.5 to 170.0
|
SECONDARY outcome
Timeframe: 12 hours (Day 0)Post-operative analgesia at 12 hours
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Cumulative 12 Hour Oral Morphine Equivalent Consumption
|
61.5 mg
Interval 40.8 to 75.0
|
49.5 mg
Interval 30.0 to 82.5
|
82 mg
Interval 49.0 to 104.0
|
SECONDARY outcome
Timeframe: 48 hours (Day 2)Post-operative analgesia at 48 hours
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Cumulative 48 Hour Oral Morphine Equivalent Consumption
|
192.9 mg
Interval 137.6 to 274.0
|
196 mg
Interval 127.9 to 277.5
|
223.5 mg
Interval 175.5 to 282.0
|
SECONDARY outcome
Timeframe: 12, 24 and 48 hoursPatient's level of pain using NRS (Numeric Ratings Scale) pain scale where the range is 0 (no pain) to 10 (worst pain)
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Pain Score
12h
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Pain Score
24h
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Pain Score
48h
|
2 score on a scale
Interval 2.0 to 3.0
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 48 hours (Day 2)Quality of recovery measured using the QoR-40 at 48 hours postoperatively. This is a validated scale where a higher score denotes better recovery/satisfaction after surgery. The range is 40-200.
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Quality of Recovery (QoR-40)
|
160.5 score on a scale
Standard Deviation 20.1
|
166.5 score on a scale
Standard Deviation 19.3
|
167.2 score on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: From surgical date until hospital discharge, up to 3 weeksTime to hospital discharge
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Length of Stay
|
70.8 hours
Interval 66.9 to 96.5
|
71.5 hours
Interval 66.3 to 89.3
|
71.5 hours
Interval 65.8 to 94.3
|
SECONDARY outcome
Timeframe: 0 to 48 hoursNumber of Participants with Nausea/Vomiting requiring anti-emetics from 0-48 hours after surgery.
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
0-12h
|
19 Participants
|
14 Participants
|
19 Participants
|
|
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
12-24h
|
26 Participants
|
17 Participants
|
24 Participants
|
|
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
24-48h
|
15 Participants
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 0 to 48 hoursfrom time zero to first press of PCA button
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Time to First Use of PCA
|
4.1 hours
Interval 2.6 to 5.1
|
4.9 hours
Interval 3.4 to 6.1
|
3.8 hours
Interval 3.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From time of catheter insertion until catheter removal, up to Day2/48 hoursIncidence of catheter dislodgement or site infection
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Adductor Canal Block Complications
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 48 hoursNerve block complications at any time point during study
Outcome measures
| Measure |
Adductor Canal Block
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
Adductor Canal Block With Dexamethasone
n=60 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
Dexamethasone: To be given intravenously at time of nerve block to one of the study arms.
|
Adductor Canal Catheter
n=57 Participants
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
Bupivacaine: Used in spinal anesthetic
Fentanyl: May or may not be used in spinal anesthetic
Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
|
|---|---|---|---|
|
Nerve Block Complications
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Adductor Canal Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adductor Canal Block With Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adductor Canal Catheter
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. Steven Lee
Department of Anesthesia and Perioperative Care, Vancouver General Hospital, Vancouver, BC, Canada.
Phone: 6048754111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place