Trial Outcomes & Findings for A Novel Analgesia Technique for ACL Reconstruction (NCT NCT03292926)
NCT ID: NCT03292926
Last Updated: 2024-09-19
Results Overview
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
24 hours post-block administration
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Adductor Canal Block (ACB)
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Adductor Canal Block & IPACK (ACB/IPACK)
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Analgesia Technique for ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Adductor Canal Block (ACB)
n=39 Participants
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Adductor Canal Block & IPACK (ACB/IPACK)
n=39 Participants
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 7 • n=5 Participants
|
25 years
STANDARD_DEVIATION 8 • n=7 Participants
|
24 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-block administrationPopulation: some patients were lost to follow up
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Outcome measures
| Measure |
Adductor Canal Block (ACB)
n=37 Participants
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Adductor Canal Block & IPACK (ACB/IPACK)
n=37 Participants
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
|---|---|---|
|
Pain While at Rest
|
3.84 score on a scale
Standard Deviation 1.86
|
3.95 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 dayPopulation: some patients lost to follow up
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
Outcome measures
| Measure |
Adductor Canal Block (ACB)
n=39 Participants
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Adductor Canal Block & IPACK (ACB/IPACK)
n=37 Participants
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
|---|---|---|
|
Discharge Criteria
|
180.67 minutes
Standard Deviation 143.84
|
189.92 minutes
Standard Deviation 254.55
|
SECONDARY outcome
Timeframe: 3 hours post-block administration on Post-operative day (POD) 0NRS Pain score with ambulation \& stairs. A lower score is a better outcome. Score range is from 0 to 10.
Outcome measures
| Measure |
Adductor Canal Block (ACB)
n=39 Participants
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
Adductor Canal Block & IPACK (ACB/IPACK)
n=39 Participants
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration
|
|---|---|---|
|
Pain With Ambulation
NRS with Ambulation
|
1.59 score on a scale
Standard Deviation 1.43
|
1.26 score on a scale
Standard Deviation 1.23
|
|
Pain With Ambulation
NRS with Stairs
|
2.05 score on a scale
Standard Deviation 1.92
|
2.1 score on a scale
Standard Deviation 1.81
|
Adverse Events
Adductor Canal Block (ACB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adductor Canal Block & IPACK (ACB/IPACK)
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. Jonathan Beathe
Hospital for Special Surgery, Anesthesiology
Phone: 2126061036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place