IPACK Block in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692858
• Other study ID #: 8885/20-06-2018
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: October 2019
• Source: Asklepieion Voulas General Hospital
• Contact: Alexandros Makris
• Phone: +306947076446
• Email: makrisalexandros[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• Adductor Canal Block plus IPACK Block
Adductor Canal Block plus IPACK Block using Ropivacaine
• Adductor Canal Block
Adductor Canal Block using Ropivacaine

Locations

Country	Name	City	State
Greece	Asklepieion Hospital of Voula	Athens

Sponsors (3)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital	Aikaterini Kalampokini, Chryssoula Staikou

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS scores	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)	48 hours
Primary	Morphine consumption	Morphine consumption in mg	24 hours
Primary	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	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
Secondary	Range of knee motion	Degrees of flexion	48 hours
Secondary	Complications		48 hours
Secondary	Patient mobilization	Patient reporting time of first standing to the side of the bed and number of steps per day	5 days
Secondary	Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Secondary	Joint function	Maximal flexion / extension	6 months
Secondary	Intestinal function	Time of first passing of rectal gas, reported by the patient	5 days