Single Dose Adductor Canal Block vs SPANK Block for TKA

April 12, 2019 updated by: Angela Curell, San Antonio Uniformed Services Health Education Consortium

Single Dose Adductor Canal Block With SPANK (Sensory Posterior Articular Nerves of the Knee) Block Compared to Single Dose Adductor Canal Block and Pain Control After Total Knee Arthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adductor Canal Block Alone
Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance
Procedure: 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
Drug: Ropivacaine Hcl 0.5% Inj Vil 30Ml
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.
Device: Pajunk sonoplex stim needle
Echogenic needle used for ultrasound guided nerve blockade.
Experimental: SPANK Block Plus Adductor Canal Block
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: 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
Drug: Ropivacaine Hcl 0.5% Inj Vil 30Ml
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.
Device: Pajunk sonoplex stim needle
Echogenic needle used for ultrasound guided nerve blockade.
Procedure: SPANK Block (Sensory Posterior Articular Nerves of the Knee)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Consumption
Time Frame: 24 hours postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: 4, 8, 12, 16, and 24 hours postoperatively
Verbal pain score measured via numerical rating scale from 1-10 at 4 hrs, 8 hrs, 12hrs, 16hrs, and 24 hours.
4, 8, 12, 16, and 24 hours postoperatively
Time to first opioid use
Time Frame: 24 hours postoperatively
The amount of time measured from when the patient leaves the operating room to the time when they receive their first dose of any opioid medication.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Antonio Uniformed Services Health Education Consortium

Investigators

  • Principal Investigator: Angela M Curell, MD, San Antonio Uniformed Services Health Education Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPANK Block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If shared, will plan to provide. All IPD that underlie results in publication

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Starting 6 months after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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