Acute Pain Clinical Trial
Official title:
A Prospective Randomized Parallel Study to Compare Post-operative Pain Control With Addition of Sensory Posterior Articular Nerve Block to Adductor Canal Block (SPANK) and Intraoperative Periarticular Infiltration in Total Knee Arthroplasty.
Verified date | November 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 1, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 90 Years |
Eligibility | Inclusion Criteria: Patients between the ages of 19 and 90 years old. BMI 18-45 ASA class I-II-III Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Shadyside Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Bruce Ben-David |
United States,
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
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pain scores at rest and with movement at 6, 12 and 24 hours after the surgery measured using Numerical Rating Scale (NRS). | Patient will describe the pain experienced after surgery in rest and in movement at 6,12,24 hours on a scale from 1-10 being 10 the worst pain ever experienced. | It will be measured at 6 hours, 12 hours, 24 hours after surgery | |
Secondary | Time to first opioid Consumption | The amount of time measured from the end of the surgery when the patient leaves the operating room to the time when they receive their first dose of any opioid medication. | During the first 24 after surgery | |
Secondary | Opioid consumption | will be measured using morphine equivalents during first 24 hours after knee surgery, starting when the patient leaves the operating room | During the first 24 after surgery | |
Secondary | Extent of motor blockade in various lower extremity muscle groups | This outcome will be reported by physical therapy on medical records | During the first 24 after surgery | |
Secondary | Time that the patient takes to walk 100 feet after surgery | This outcome will be reported by physical therapy on medical records | During the first 24 after surgery | |
Secondary | Patient satisfaction with the pain management strategy provided after first 24 hours. | patient satisfaction survey will be answered by the patient at 24 hours after surgery. This questionnaire will have a score of satisfaction from1-5, being 5 the maximum satisfaction experienced by the patient. | During the first 24 after surgery | |
Secondary | Local anesthetic toxicity reported in the medical records if is present. | Local Anesthetic Toxicity is defined by symptoms such as metallic taste, tinnitus, drowsiness, after administering a dose of local anesthetics.This will be reported in the medical record and by the physician on call.t We will measure the number of participants that present these kind of symptoms if any. | During the first 24 after surgery | |
Secondary | Nausea and vomiting | The presence or absence of nausea and vomiting, and the number of episodes during the first 24 hours after surgery.The outcome assessor will ask directly to the patient about this symptoms.we will measure the number of patients that report these symptoms. | During the first 24 after surgery |
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