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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03502889
Other study ID # SPANK Block
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2019
Est. completion date June 2020

Study information

Verified date April 2019
Source San Antonio Uniformed Services Health Education Consortium
Contact Angela M Curell, MD
Phone (210) 220-7450
Email angela.m.curell2.mil@mail.mil
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date June 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
San Antonio Uniformed Services Health Education Consortium

References & Publications (11)

Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. Review. — View Citation

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. Review. — View Citation

Feibel RJ, Dervin GF, Kim PR, Beaulé 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Postoperative Pain Scores 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
Secondary Time to first opioid use 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
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