The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

Knee Arthroplasty, Total Clinical Trial

Official title:

The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703206
• Other study ID #: 828618
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: August 27, 2021

Study information

• Verified date: July 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for total knee arthroplasty
• American Society Anesthesiologists (ASA) physical status I- III.
• Mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

• Patient refusal,
• allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
• Revision surgery will be excluded.
• Impaired kidney functions
• patient with coagulopathy will be also excluded.
• Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
• BMI of 45 or more

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients presenting with pain in the back of the knee 6 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	Six hours after surgery
Secondary	Pain score measurement reported by patients	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.	24 hours after surgery
Secondary	Quality of recovery (QoR) score	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	one week, measurements are obtained at 24 hours, 48 hours, and one week