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Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction

Primary Purpose

Rupture of Anterior Cruciate Ligament, Tear of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mepivacaine
adductor canal continuous nerve catheter
Normal Saline as bolus followed by bupivacaine
adductor canal nerve block
ropivacaine and dexamethasone
Propofol
Fentanyl
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 14 and older
  • Patients who are scheduled to undergo an ACL reconstruction with patella or allograft
  • Patient does not have a contraindication to receiving regional anesthesia

Exclusion Criteria:

  • Allergy to local anesthetics, dexamethasone, or adhesive tape
  • Patients undergoing hamstring graft for ACL
  • Preexisting infection at site of needle insertion
  • Immunocompromised patients
  • Preexisting sensory or motor deficit in operative extremity
  • Patient on chronic opioid treatment.
  • Patient having a revision of previous ACL reconstruction.
  • Pregnancy and lactating women

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous Adductor Canal Nerve Catheter

Long Acting Single Bolus Adductor Canal Nerve Block

Arm Description

Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.

Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.

Outcomes

Primary Outcome Measures

Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU.
Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU
Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).

Secondary Outcome Measures

Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.
Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.
Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter.
Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).
Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)
Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain).
Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain
Postoperative Nausea and Vomiting
Postoperative nausea and vomiting score on POD 1 following discharge from PACU
Subjective Assessment of Experience With Analgesia
Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations
Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.
Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.

Full Information

First Posted
October 14, 2015
Last Updated
November 27, 2019
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02584452
Brief Title
Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction
Official Title
Randomized Controlled Trial Evaluating Postoperative Analgesia and Muscle Strength Between Single Versus Continuous Adductor Canal Block for Ambulatory ACL Reconstruction.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite the apparent multifaceted benefit in differentiating blockade sites and duration of nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in ACL reconstruction has not been extensively studied. This study will test the hypothesis that the use of the adductor canal continuous nerve catheter will result in lower subjective pain scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.
Detailed Description
Study participants will be randomized to 2 groups: (1) continuous adductor canal nerve catheter or (2) long-acting single bolus adductor canal nerve block. Following random selection via random envelope selection patients will receive the following procedures. Both groups will receive ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative care will consist of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert, Group 1 patients 1 will receive ultrasound guided adductor canal continuous nerve catheter using normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through catheter at 8cc/h. Group 2 will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine + 2mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve14. After adequate instruction including catheter education (if applicable) patients are to be discharged home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament, Tear of Anterior Cruciate Ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Adductor Canal Nerve Catheter
Arm Type
Active Comparator
Arm Description
Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.
Arm Title
Long Acting Single Bolus Adductor Canal Nerve Block
Arm Type
Active Comparator
Arm Description
Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
Carbocaine, Polocaine
Intervention Description
20cc of 2% mepivacaine <20 minutes prior to in room time.
Intervention Type
Procedure
Intervention Name(s)
adductor canal continuous nerve catheter
Intervention Description
Placement of ultrasound guided adductor canal continuous nerve catheter
Intervention Type
Drug
Intervention Name(s)
Normal Saline as bolus followed by bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through adductor canal catheter at 8cc/h
Intervention Type
Procedure
Intervention Name(s)
adductor canal nerve block
Intervention Description
ultrasound guided adductor canal nerve block
Intervention Type
Drug
Intervention Name(s)
ropivacaine and dexamethasone
Other Intervention Name(s)
Naeopin
Intervention Description
10cc of 0.5% ropivacaine + 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan, Propoven
Intervention Description
Anesthesia induction will include a propofol bolus.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze
Intervention Description
Intraoperative opioid should be limited to no more than 150mcg of fentanyl.
Primary Outcome Measure Information:
Title
Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU.
Description
Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Time Frame
Post Operative Day 2
Title
Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU
Description
Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).
Time Frame
Post Operative Day 1
Secondary Outcome Measure Information:
Title
Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Description
Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Time Frame
Post Operative Day 1
Title
Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.
Description
Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.
Time Frame
Post Operative Day 2 and 3
Title
Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter.
Description
Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).
Time Frame
Post Operative Week 6
Title
Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)
Time Frame
Post Operative Day 1
Title
Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Description
Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain).
Time Frame
Post Operative Week 6
Title
Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain
Time Frame
Post Operative Week 6
Title
Postoperative Nausea and Vomiting
Description
Postoperative nausea and vomiting score on POD 1 following discharge from PACU
Time Frame
POD 1 following discharge from PACU
Title
Subjective Assessment of Experience With Analgesia
Description
Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations
Time Frame
Post Operative Week 6
Title
Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block
Description
Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
Time Frame
Post Operative Day 3
Title
Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.
Description
Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.
Time Frame
Post Operative Day1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 14 and older Patients who are scheduled to undergo an ACL reconstruction with patella or allograft Patient does not have a contraindication to receiving regional anesthesia Exclusion Criteria: Allergy to local anesthetics, dexamethasone, or adhesive tape Patients undergoing hamstring graft for ACL Preexisting infection at site of needle insertion Immunocompromised patients Preexisting sensory or motor deficit in operative extremity Patient on chronic opioid treatment. Patient having a revision of previous ACL reconstruction. Pregnancy and lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sobey, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11172507
Citation
Mulroy MF, Larkin KL, Batra MS, Hodgson PS, Owens BD. Femoral nerve block with 0.25% or 0.5% bupivacaine improves postoperative analgesia following outpatient arthroscopic anterior cruciate ligament repair. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):24-9. doi: 10.1053/rapm.2001.20773.
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Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.
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Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction

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