IPACK Block in Total Knee Arthroplasty

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Alexandros Makris，Asklepieion Voulas General Hospital

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

NRS scores[ Time Frame: 48 hours ]

Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

Morphine consumption[ Time Frame: 24 hours ]

Morphine consumption in mg

Chronic pain[ Time Frame: 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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

IPACK Block in Total Knee Arthroplasty

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Active Comparator: Group A
Active Comparator: Group B

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

14 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Alexandros Makris，Asklepieion Voulas General Hospital

Study Sponsor ^ICMJE

Asklepieion Voulas General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Asklepieion Voulas General Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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