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

NCT02584452 | Completed Results

• 1 other identifier: 151095
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture of Anterior Cruciate Ligament; Tear of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (2)

• 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).

  Post Operative Day 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

  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).

  Post Operative Day 1

Secondary Outcomes (10)

• 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 Day 2 and 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.

  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

• 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

Study Arms (2)

Continuous Adductor Canal Nerve Catheter

ACTIVE COMPARATOR

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.

Drug: Mepivacaine; Procedure: adductor canal continuous nerve catheter; Drug: Normal Saline as bolus followed by bupivacaine; Drug: Propofol; Drug: Fentanyl

Long Acting Single Bolus Adductor Canal Nerve Block

ACTIVE COMPARATOR

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.

Drug: Mepivacaine; Procedure: adductor canal nerve block; Drug: ropivacaine and dexamethasone; Drug: Propofol; Drug: Fentanyl

Interventions

Mepivacaine DRUG

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

Also known as: Carbocaine, Polocaine

Continuous Adductor Canal Nerve Catheter; Long Acting Single Bolus Adductor Canal Nerve Block

adductor canal continuous nerve catheter PROCEDURE

Placement of ultrasound guided adductor canal continuous nerve catheter

Continuous Adductor Canal 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

Also known as: Marcaine

Continuous Adductor Canal Nerve Catheter

adductor canal nerve block PROCEDURE

ultrasound guided adductor canal nerve block

Long Acting Single Bolus 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

Also known as: Naeopin

Long Acting Single Bolus Adductor Canal Nerve Block

Propofol DRUG

Anesthesia induction will include a propofol bolus.

Also known as: Diprivan, Propoven

Continuous Adductor Canal Nerve Catheter; Long Acting Single Bolus Adductor Canal Nerve Block

Fentanyl DRUG

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

Also known as: Sublimaze

Continuous Adductor Canal Nerve Catheter; Long Acting Single Bolus Adductor Canal Nerve Block

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (15)

• 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.

  PMID: 11172507 BACKGROUND

• Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

  PMID: 20889937 BACKGROUND

• 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.

  PMID: 16108583 BACKGROUND

• Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24.

  PMID: 23440367 BACKGROUND

• Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

  PMID: 23241723 BACKGROUND

• Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

  PMID: 24121608 BACKGROUND

• Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y.

  PMID: 23897505 BACKGROUND

• Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

  PMID: 22221014 BACKGROUND

• Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.

  PMID: 21039357 BACKGROUND

• Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.

  PMID: 24205802 BACKGROUND

• Espelund M, Grevstad U, Jaeger P, Holmich P, Kjeldsen L, Mathiesen O, Dahl JB. Adductor canal blockade for moderate to severe pain after arthroscopic knee surgery: a randomized controlled trial. Acta Anaesthesiol Scand. 2014 Nov;58(10):1220-7. doi: 10.1111/aas.12407.

  PMID: 25307707 BACKGROUND

• Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.

  PMID: 23549123 BACKGROUND

• Chisholm MF, Bang H, Maalouf DB, Marcello D, Lotano MA, Marx RG, Liguori GA, Zayas VM, Gordon MA, Jacobs J, YaDeau JT. Postoperative Analgesia with Saphenous Block Appears Equivalent to Femoral Nerve Block in ACL Reconstruction. HSS J. 2014 Oct;10(3):245-51. doi: 10.1007/s11420-014-9392-x. Epub 2014 Jun 7.

  PMID: 25264441 BACKGROUND

• Andersen HL, Andersen SL, Tranum-Jensen J. The spread of injectate during saphenous nerve block at the adductor canal: a cadaver study. Acta Anaesthesiol Scand. 2015 Feb;59(2):238-45. doi: 10.1111/aas.12451. Epub 2014 Dec 14.

  PMID: 25496028 BACKGROUND

• Lewek M, Rudolph K, Axe M, Snyder-Mackler L. The effect of insufficient quadriceps strength on gait after anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2002 Jan;17(1):56-63. doi: 10.1016/s0268-0033(01)00097-3.

  PMID: 11779647 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Mepivacaine; Saline Solution; Bupivacaine; Ropivacaine; Dexamethasone; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Christopher Sobey, MD
• Organization: Vanderbilt University Medical Center

christopher.m.sobey@vumc.org

615-322-4311

Study Officials

• Christopher Sobey, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 22, 2015
• Study Start: November 3, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 10, 2018
• Last Updated: December 11, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)