A Novel Analgesia Technique for ACL Reconstruction

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03292926
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Injury	Drug: Bupivacaine; Device: Ultrasound; Drug: Dexamethasone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
• Actual Study Start Date: Oct 4, 2017
• Actual Primary Completion Date: Mar 16, 2021
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Bupivacaine; Bupivacaine will help treat pain and sensation after ACL repair; Device: Ultrasound; Ultrasound will guide anesthesiologist in performing the different nerve blocks; Drug: Dexamethasone; Dexamethasone will be used to prolong block duration; Other Names: preservative free Dexamethasone
Active Comparator: 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.	Drug: Bupivacaine; Bupivacaine will help treat pain and sensation after ACL repair; Device: Ultrasound; Ultrasound will guide anesthesiologist in performing the different nerve blocks; Drug: Dexamethasone; Dexamethasone will be used to prolong block duration; Other Names: preservative free Dexamethasone

Outcome Measures

Primary Outcome Measures

1. Pain While at Rest [24 hours post-block administration]

   Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.

Secondary Outcome Measures

1. Discharge Criteria [3 hours post-block administration on Post-operative day (POD) 0]

   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.

2. Pain With Ambulation [3 hours post-block administration on Post-operative day (POD) 0]

   NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing BTB ACL reconstruction with participating surgeon

• Age 13 or greater

• Planned use of regional anesthesia

• Ability to follow study protocol

• English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion Criteria:

• Hepatic or renal insufficiency

• Younger than 13 years old

• Patients undergoing general anesthesia

• Allergy or intolerance to one of the study medications

• BMI > 40

• Diabetes

• American Society of Anesthesiology (ASA) score IV

• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

• Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)

• Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10023

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Jonathan Beathe, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 25, 2019

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03292926
• Other Study ID Numbers: 2017-0934
• First Posted: Sep 26, 2017
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries; Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101

Study Results

Participant Flow

Arm/Group Title	Adductor Canal Block (ACB)	Adductor Canal Block & IPACK (ACB/IPACK)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	39	39
COMPLETED	39	39
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Adductor Canal Block (ACB)	Adductor Canal Block & IPACK (ACB/IPACK)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	39	39	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23 (7)	25 (8)	24 (7)
Sex: Female, Male (Count of Participants)
Female	13 33.3%	12 30.8%	25 32.1%
Male	26 66.7%	27 69.2%	53 67.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 10.3%	6 15.4%	10 12.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 12.8%	5 12.8%	10 12.8%
White	26 66.7%	20 51.3%	46 59%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 10.3%	8 20.5%	12 15.4%
Region of Enrollment (participants) [Number]
United States	39 100%	39 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Pain While at Rest
Description	Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Time Frame	24 hours post-block administration

Outcome Measure Data

Analysis Population Description

some patients were lost to follow up

Arm/Group Title	Adductor Canal Block (ACB)	Adductor Canal Block & IPACK (ACB/IPACK)
Arm/Group Description	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	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
Measure Participants	37	37
Mean (Standard Deviation) [score on a scale]	3.84 (1.86)	3.95 (2.58)

2. Secondary Outcome

Title	Discharge Criteria
Description	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.
Time Frame	3 hours post-block administration on Post-operative day (POD) 0

Outcome Measure Data

Analysis Population Description

some patients lost to follow up

Arm/Group Title	Adductor Canal Block (ACB)	Adductor Canal Block & IPACK (ACB/IPACK)
Arm/Group Description	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	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
Measure Participants	39	37
Mean (Standard Deviation) [minutes]	180.67 (143.84)	189.92 (254.55)

3. Secondary Outcome

Title	Pain With Ambulation
Description	NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.
Time Frame	3 hours post-block administration on Post-operative day (POD) 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adductor Canal Block (ACB)	Adductor Canal Block & IPACK (ACB/IPACK)
Arm/Group Description	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	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
Measure Participants	39	39
NRS with Ambulation	1.59 (1.43)	1.26 (1.23)
NRS with Stairs	2.05 (1.92)	2.1 (1.81)

Adverse Events

Time Frame	up to 7 days after surgery
Arm/Group Title	Adductor Canal Block (ACB)		Adductor Canal Block & IPACK (ACB/IPACK)
Arm/Group Description	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		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
All Cause Mortality
	Adductor Canal Block (ACB)		Adductor Canal Block & IPACK (ACB/IPACK)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Serious Adverse Events
	Adductor Canal Block (ACB)		Adductor Canal Block & IPACK (ACB/IPACK)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Adductor Canal Block (ACB)		Adductor Canal Block & IPACK (ACB/IPACK)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.