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Clinical Trials/NCT02584452
NCT02584452
Completed
N/A

Randomized Controlled Trial Evaluating Postoperative Analgesia and Muscle Strength Between Single Versus Continuous Adductor Canal Block for Ambulatory ACL Reconstruction.

Vanderbilt University Medical Center1 site in 1 country59 target enrollmentNovember 3, 2015

Overview

Phase
N/A
Intervention
Mepivacaine
Conditions
Rupture of Anterior Cruciate Ligament
Sponsor
Vanderbilt University Medical Center
Enrollment
59
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2015
End Date
April 10, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Sobey

Assistant Professor of Anesthesiology & Pain Medicine

Vanderbilt University Medical Center

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

Arms & Interventions

Continuous Adductor Canal Nerve Catheter

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.

Intervention: Mepivacaine

Continuous Adductor Canal Nerve Catheter

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.

Intervention: adductor canal continuous nerve catheter

Long Acting Single Bolus Adductor Canal Nerve Block

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: adductor canal nerve block

Continuous Adductor Canal Nerve Catheter

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.

Intervention: Normal Saline as bolus followed by bupivacaine

Continuous Adductor Canal Nerve Catheter

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.

Intervention: Propofol

Continuous Adductor Canal Nerve Catheter

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.

Intervention: Fentanyl

Long Acting Single Bolus Adductor Canal Nerve Block

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: Mepivacaine

Long Acting Single Bolus Adductor Canal Nerve Block

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: ropivacaine and dexamethasone

Long Acting Single Bolus Adductor Canal Nerve Block

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: Propofol

Long Acting Single Bolus Adductor Canal Nerve Block

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: Fentanyl

Outcomes

Primary Outcomes

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.

Time Frame: Post Operative Day 2

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

Time Frame: Post Operative Day 1

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 Outcomes

  • Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain(Post Operative Week 6)
  • Subjective Assessment of Experience With Analgesia(Post Operative Week 6)
  • 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(Post Operative Day 1)
  • 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.(Post Operative Day1)
  • 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(Post Operative Week 6)
  • 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.(Post Operative Week 6)
  • Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)(Post Operative Day 1)
  • Postoperative Nausea and Vomiting(POD 1 following discharge from PACU)
  • 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(Post Operative Day 3)

Study Sites (1)

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