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Trial record 33 of 88 for:    Recruiting, Not yet recruiting, Available Studies | "Anterior Cruciate Ligament"

A Novel Analgesia Technique for ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT03292926
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : October 4, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: preservative free Dexamethasone




Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours post-block administration ]
    Average numerical rating scale (NRS) at rest


Secondary Outcome Measures :
  1. Discharge criteria [ Time Frame: 3 hours post-block administration on Post-operative day (POD) 0 ]
    Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system

  2. Pain [ Time Frame: 3 hours post-block administration on Post-operative day (POD) 0 ]
    NRS Pain score with ambulation & stairs



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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292926


Contacts
Contact: Nicole Brunetti, BS 646-714-6794 ext 6794 brunettin@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10023
Principal Investigator: Jonathan Beathe, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jonathan Beathe, MD Hospital for Special Surgery, New York

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03292926     History of Changes
Other Study ID Numbers: 2017-0934
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Knee Injuries
Leg Injuries
Wounds and Injuries
Dexamethasone acetate
Dexamethasone
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents