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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03692858
Enrollment
100
Registered
2018-10-02
Start date
2018-10-01
Completion date
2020-07-31
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

arthroplasty, replacement, knee

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.

Interventions

Adductor Canal Block plus IPACK Block using Ropivacaine

DRUGAdductor Canal Block

Adductor Canal Block using Ropivacaine

Sponsors

Aikaterini Kalampokini
CollaboratorUNKNOWN
Chryssoula Staikou
CollaboratorUNKNOWN
Asklepieion Voulas General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NRS scores48 hoursNumerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption24 hoursMorphine consumption in mg
Chronic pain6 monthsUsing 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

MeasureTime frameDescription
Patient mobilization5 daysPatient reporting time of first standing to the side of the bed and number of steps per day
Patient satisfaction48 hoursPatients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Delirium occurence48 hoursNu-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.
Intestinal function5 daysTime of first passing of rectal gas, reported by the patient
Joint function6 monthsMaximal flexion / extension
Range of knee motion48 hoursDegrees of flexion
Complications48 hours

Countries

Greece

Contacts

Primary ContactAlexandros Makris
makrisalexandros@hotmail.com+306947076446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026