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NCT Number: NCT02584452

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

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.

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Tear of Anterior Cruciate Ligament Wounds and Injuries

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepivacaine

Drug

20cc of 2% mepivacaine <20 minutes prior to in room time.

Other names: Carbocaine, Polocaine

adductor canal continuous nerve catheter

Procedure

Placement of ultrasound guided adductor canal continuous nerve catheter

Normal Saline as bolus followed by bupivacaine

Drug

normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through adductor canal catheter at 8cc/h

Other names: Marcaine

Adductor Canal Nerve Block

Procedure

ultrasound guided adductor canal nerve block

Ropivacaine and Dexamethasone

Drug

10cc of 0.5% ropivacaine + 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve

Other names: Naeopin

Propofol

Drug

Anesthesia induction will include a propofol bolus.

Other names: Diprivan, Propoven

Fentanyl

Drug

Intraoperative opioid should be limited to no more than 150mcg of fentanyl.

Other names: Sublimaze

Primary outcomes

  1. 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).

  2. 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

  1. 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

    Time frame: Post Operative Day 1

    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).

  2. 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.

    Time frame: Post Operative Day 2 and 3

    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.

  3. 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.

    Time frame: 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 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).

  4. Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)

    Time frame: Post Operative Day 1

  5. 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

    Time frame: Post Operative Week 6

    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).

  6. Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain

    Time frame: Post Operative Week 6

  7. Postoperative Nausea and Vomiting

    Time frame: POD 1 following discharge from PACU

    Postoperative nausea and vomiting score on POD 1 following discharge from PACU

  8. Subjective Assessment of Experience With Analgesia

    Time frame: Post Operative Week 6

    Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations

  9. 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

    Time frame: Post Operative Day 3

    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).

  10. 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.

    Time frame: Post Operative Day1

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2015
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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