NCT03502889

Brief Summary

This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. The primary outcome is pain control, which will be measured throughout the post-operative course using morphine equivalents of opioid analgesics used during the first 24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20, and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and vomiting, and extent of motor blockade. The study will aid in answering the question of whether SPANK block is an effective adjunct in preventing pain and decreasing opioid requirement after TKA.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

March 13, 2018

Last Update Submit

April 12, 2019

Conditions

Keywords

Total Knee ArthroplastySPANK BlockAdductor Canal BlockRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Opioid Consumption

    Amount of opioids used within the first 24 hours post-operatively, starting from when the patient leaves the operating room, measured in PO morphine equivalents

    24 hours postoperatively

Secondary Outcomes (2)

  • Postoperative Pain Scores

    4, 8, 12, 16, and 24 hours postoperatively

  • Time to first opioid use

    24 hours postoperatively

Study Arms (2)

Adductor Canal Block Alone

ACTIVE COMPARATOR

Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance

Procedure: Adductor Canal BlockDrug: Ropivacaine Hcl 0.5% Inj Vil 30MlDevice: Pajunk sonoplex stim needle

SPANK Block Plus Adductor Canal Block

EXPERIMENTAL

Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

Procedure: SPANK Block (Sensory Posterior Articular Nerves of the Knee)Procedure: Adductor Canal BlockDrug: Ropivacaine Hcl 0.5% Inj Vil 30MlDevice: Pajunk sonoplex stim needle

Interventions

Injection of local anesthetic into the tissues on the posterior aspect of the knee to provide sensory blockade of the articular nerves of the knee.

SPANK Block Plus Adductor Canal Block

Injection of local anesthetic into the inner thigh under ultrasound guidance to provide sensory blockade to the anterior aspect of the knee

Adductor Canal Block AloneSPANK Block Plus Adductor Canal Block

Amide local anesthetic, this concentration is commonly used to achieve surgical level anesthesia. The drug itself is not being studied and the same concentration will be used in all participants.

Adductor Canal Block AloneSPANK Block Plus Adductor Canal Block

Echogenic needle used for ultrasound guided nerve blockade.

Adductor Canal Block AloneSPANK Block Plus Adductor Canal Block

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia.
  • BMI \<45
  • ASA class III or less

You may not qualify if:

  • Inability to sign consent form
  • Allergy to medications used in the study
  • Repeat surgery
  • History of seizure disorder
  • Simultaneous bilateral TKA
  • History of substance abuse
  • BMI \>45
  • Opioid consumption of greater or equal to 30mg morphine equivalents per day
  • Age \<40 or \>80 years old
  • ASA IV or greater
  • Inability to use a PCA
  • Inability to access the intrathecal space
  • Infection at the site of injection (either for spinal or PNB)
  • INR greater than or equal to 1.4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.

    PMID: 28288050BACKGROUND
  • Gao F, Ma J, Sun W, Guo W, Li Z, Wang W. Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2017 Apr;33(4):356-368. doi: 10.1097/AJP.0000000000000402.

    PMID: 27322397BACKGROUND
  • Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721.

    PMID: 28079176BACKGROUND
  • Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.

    PMID: 28273133BACKGROUND
  • Li D, Ma GG. Analgesic efficacy and quadriceps strength of adductor canal block versus femoral nerve block following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2614-9. doi: 10.1007/s00167-015-3874-3. Epub 2015 Nov 26.

    PMID: 26611901BACKGROUND
  • Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.

    PMID: 25111605BACKGROUND
  • Pelt CE, Anderson AW, Anderson MB, Van Dine C, Peters CL. Postoperative falls after total knee arthroplasty in patients with a femoral nerve catheter: can we reduce the incidence? J Arthroplasty. 2014 Jun;29(6):1154-7. doi: 10.1016/j.arth.2014.01.006. Epub 2014 Jan 16.

    PMID: 24581899BACKGROUND
  • Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.

    PMID: 24641894BACKGROUND
  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PMID: 24401769BACKGROUND
  • Wasserstein D, Farlinger C, Brull R, Mahomed N, Gandhi R. Advanced age, obesity and continuous femoral nerve blockade are independent risk factors for inpatient falls after primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1121-4. doi: 10.1016/j.arth.2012.08.018. Epub 2012 Dec 21.

    PMID: 23265274BACKGROUND
  • Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.

    PMID: 19553071BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Angela M Curell, MD

    San Antonio Uniformed Services Health Education Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Resident

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 19, 2018

Study Start

June 1, 2019

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04