NCT03692858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

September 30, 2018

Last Update Submit

October 21, 2019

Conditions

Total Knee Arthroplasty

Keywords

arthroplastyreplacementknee

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Delirium occurence

    48 hours

  • Range of knee motion

    48 hours

  • Complications

    48 hours

  • Patient mobilization

    5 days

  • Patient satisfaction

    48 hours

  • +2 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR
Drug: Adductor Canal Block plus IPACK Block

Group B

ACTIVE COMPARATOR
Drug: Adductor Canal Block

Interventions

Adductor Canal Block plus IPACK BlockDRUG

Adductor Canal Block plus IPACK Block using Ropivacaine

Group A
Adductor Canal BlockDRUG

Adductor Canal Block using Ropivacaine

Group B

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepieion Hospital of Voula

Athens, 16673, Greece

RECRUITING

Central Study Contacts

Alexandros Makris

CONTACT

+306947076446makrisalexandros@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 2, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

GR(1)