Clinical trial NCT02584452: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Tear of Anterior Cruciate Ligament
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 59
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Post Operative Day 2
measure: 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
timeFrame: Post Operative Day 1
Secondary outcomes:
measure: 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
timeFrame: Post Operative Day 1
measure: 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.
timeFrame: Post Operative Day 2 and 3
measure: 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.
timeFrame: Post Operative Week 6
measure: Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)
timeFrame: Post Operative Day 1
measure: 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
timeFrame: Post Operative Week 6
measure: Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain
timeFrame: Post Operative Week 6
measure: Postoperative Nausea and Vomiting
timeFrame: POD 1 following discharge from PACU
measure: Subjective Assessment of Experience With Analgesia
timeFrame: Post Operative Week 6
measure: 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
timeFrame: Post Operative Day 3
measure: 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.
timeFrame: Post Operative Day1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Christopher Sobey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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