IPACK Block in Total Knee Arthroplasty

IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study

100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.

Study Overview

• Status: Unknown
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: Adductor Canal Block plus IPACK Block; Drug: Adductor Canal Block

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 16673
    • Recruiting
    • Asklepieion Hospital of Voula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physical status according to American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for total knee arthroplasty

Exclusion Criteria:

• Previous operation on same knee
• Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
• BMI above 32
• Serious psychiatric, mental and cognitive disorders
• Language barrier
• Block failure
• Chronic opioid, gabapentinoid use
• Severe kidney disfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group B	Drug: Adductor Canal Block; Adductor Canal Block using Ropivacaine
ACTIVE_COMPARATOR: Group A	Drug: Adductor Canal Block plus IPACK Block; Adductor Canal Block plus IPACK Block using Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS scores	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)	48 hours
Morphine consumption	Morphine consumption in mg	24 hours
Chronic pain	Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Delirium occurence	Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.	48 hours
Range of knee motion	Degrees of flexion	48 hours
Complications		48 hours
Patient mobilization	Patient reporting time of first standing to the side of the bed and number of steps per day	5 days
Joint function	Maximal flexion / extension	6 months
Intestinal function	Time of first passing of rectal gas, reported by the patient	5 days

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital
• Collaborators: Chryssoula Staikou; Aikaterini Kalampokini

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: September 30, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: knee; arthroplasty; replacement
• Other Study ID Numbers: 8885/20-06-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No