The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
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|ClinicalTrials.gov Identifier: NCT03703206|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Knee Arthroplasty, Total||Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: ACB + iPACK
Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK).
Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)
nerve block for posterior knee pain after a TKA.
Other Name: iPACK
No Intervention: ACB w/o iPACK
Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.
- Percentage of patients presenting with pain in the back of the knee 6 hours after surgery [ Time Frame: Six hours after surgery ]Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator
- Pain score measurement reported by patients [ Time Frame: 24 hours after surgery ]Average of pain scores over the first 24 hours following the regional anesthetic based on numeric rating scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible.
- Quality of recovery (QoR) score [ Time Frame: one week, measurements are obtained at 24 hours, 48 hours, and one week ]Score of QoR-15 survey to determine recovery status. the questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts.Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). the second part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). the total score is obtained by adding the scores of all the 15 questions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703206
|Contact: Nabil Elkassbany, MDemail@example.com|
|Contact: Aliaksei Basatski, BS||2156623772||Aliaksei.Basatski@pennmedicine.upenn.edu|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nabil Elkassabany, MD firstname.lastname@example.org|
|Principal Investigator:||Taras Grosh, MD||University of Pennsylvania|