Adductor Canal Vs Adductor Canal Plus SPANK Block for Postoperative Pain in Knee Arthroplasty Surgery

NCT04290442 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY19120105
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will prospectively investigate the efficacy of Adductor canal block with periarticular infiltration Vs Adductor canal block, Periarticluar infiltration and Sensory posterior articular nerve of the knee block in patients undergoing total knee arthroplasty. The study will aid in answering question whether SPANK block is an effective adjunct in preventing posterior knee pain without causing motor blockade.

Conditions

Arthroplasty, Replacement, Knee; Anesthesia, Conduction; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Pain score using Numerical rating Scale (NRS) with ambulation at 24 hours after total knee arthroplasty

  Patient will describe the pain experienced after surgery on a scale from 1-10 being 10 the worst pain ever experienced, this will be registered in the format designed for this purpose and at the end of the study will be analyzed

  At 24 hours after surgery

Secondary Outcomes (8)

• Pain scores at rest and with movement at 6, 12 and 24 hours after the surgery measured using Numerical Rating Scale (NRS).

  It will be measured at 6 hours, 12 hours, 24 hours after surgery

• Time to first opioid Consumption

  During the first 24 after surgery

• Opioid consumption

  During the first 24 after surgery

• Extent of motor blockade in various lower extremity muscle groups

  During the first 24 after surgery

• Time that the patient takes to walk 100 feet after surgery

  During the first 24 after surgery

Study Arms (2)

Adductor canal block (ACB)

ACTIVE COMPARATOR

Procedure: adductor canal block; Drug: Ropivacaine

Adductor canal block plus SPANK block

EXPERIMENTAL

Procedure: adductor canal block; Procedure: SPANK; Drug: Ropivacaine

Interventions

adductor canal block PROCEDURE

The block is performed in supine position under ultrasound guidance using 22 G Touhy needle advanced in plane and 15 cc of 0.5% Ropivacaine ( local anesthetic) with dexmedetomidine 20-30 mcg depending on the age of the patient is injected at midthigh level lateral to the femoral artery in adductor canal to provide sensory blockade to the anterior aspect of the knee.

Adductor canal block (ACB); Adductor canal block plus SPANK block

SPANK PROCEDURE

SPANK: The block is performed in supine position, using 22 G Touhy needle, under ultrasound guidance, needle is advanced in plane to posteromedial shaft of femur taking care to avoid popliteal artery, and 0.5% ropivacaine 15 cc, dexmedetomidine 20-30mcg and dexamethasone 4 mg is injected into inner thigh above the knee provide sensory block to posterior aspect of the knee.

Adductor canal block plus SPANK block

Ropivacaine DRUG

ropivacaine 0.5% will be use in the block

Adductor canal block (ACB); Adductor canal block plus SPANK block

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 19 and 90 years old. BMI 18-45 ASA class I-II-III

You may not qualify if:

• Simultaneous bilateral TKA.
• History of substance abuse.
• BMI \>45.
• Patients that did not received Intrathecal anesthesia.
• Infection at the site of injection (either for spinal or PNB).
• Pregnancy.
• Non english speaking or inability to participate in the study.
• Patients with coagulopathy or With INR \>1,5 the day of the surgery.
• Pharmacologic coagulopathy: patients on xarelto, plavix, or any kind of "Blood Thinners".
• Chronic steroid use: patients with consumption of steroid for more than 3 months.
• Chronic pain: pain for more than 3 months.
• Chronic opiate use : consumption of opioids for more than 3 months.

Sponsors & Collaborators

• Bruce Ben-David: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (3)

• 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: 28273133 BACKGROUND

• Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.

  PMID: 27871547 BACKGROUND

• Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.

  PMID: 29721648 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bruce Ben-David, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the office of acute pain management, one member of the research team will be responsible for providing the anesthesiologist in charge of performing the block with a sealed envelope. Each envelope will be labeled with a number corresponding to a matching number labeled on each patient binder. This envelope will contain the information regarding the block type based on randomization to be administered to the patient. Once the anesthesiologist knows which block he is going to administer, he will reseal the envelope and return it to the research team member. This process will allow only the anesthesiologist performing the block to have knowledge of the block type he or she is administering, keeping research team members blinded. The envelopes and binders will be kept by the principal investigator in a safe place and only reopened to be analyzed at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The study will be conducted as prospective, randomized, single blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: January 1, 2021
• Primary Completion: March 15, 2021
• Study Completion: June 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)