IPACK Block in Total Knee Arthroplasty

Phase 2

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: Adductor Canal Block plus IPACK Block; Drug: Adductor Canal Block

• Registration Number: NCT03692858
• Lead Sponsor: Asklepieion Voulas General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-09-30
• Study Start: 2018-10-01
• Study First Posted: 2018-10-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Adductor Canal Block plus IPACK Block	-
Group B	Adductor Canal Block	-

Primary Outcome Measures

Name	Time	Method
NRS scores	48 hours	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption	24 hours	Morphine consumption in mg
Chronic pain	6 months	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	48 hours	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Intestinal function	5 days	Time of first passing of rectal gas, reported by the patient
Patient mobilization	5 days	Patient reporting time of first standing to the side of the bed and number of steps per day
Range of knee motion	48 hours	Degrees of flexion
Delirium occurence	48 hours	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.
Joint function	6 months	Maximal flexion / extension
Complications	48 hours

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Greece