NCT06086483

Brief Summary

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 18, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Knee OsteoarthritisKnee ArthritisKnee ArthropathyKnee Pain Chronic

Keywords

iPACKAdductor Canal Blockpain managementmultimodal analgesiaperipheral nerve blockknee arthroplasty

Outcome Measures

Primary Outcomes (7)

  • postoperative Numeric Pain Rating Scale

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    24 hours after surgery

  • postoperative Numeric Pain Rating Scale et rest

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    48 hours after surgery

  • postoperative Numeric Pain Rating Scale et rest

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    72 hours after surgery

  • postoperative Numeric Pain Rating Scale et rest

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    96 hours after surgery

  • postoperative Numeric Pain Rating Scale during active flexion

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    48 hours after surgery

  • postoperative Numeric Pain Rating Scale during active flexion

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    72 hours after surgery

  • postoperative Numeric Pain Rating Scale during active flexion

    Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    96 hours after surgery

Secondary Outcomes (6)

  • Postoperative opioid consumption

    96 hours after surgery

  • Neutrophil-to-lymphocyte ratio

    12 hours after surgery

  • Neutrophil-to-lymphocyte ratio

    24 hours after surgery

  • Platelet-to-lymphocyte ratio

    12 hours after surgery

  • Platelet-to-lymphocyte ratio

    24 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

iPACK block+ABC block

ACTIVE COMPARATOR

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.

Drug: Ropivacaine 0.2% Injectable Solution

Sham blocks

ACTIVE COMPARATOR

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.

Drug: 0.9%sodium chloride

Interventions

Ropivacaine 0.2% Injectable SolutionDRUG

20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block

Also known as: Ropimol
iPACK block+ABC block
0.9%sodium chlorideDRUG

20 mL 0.9% sodium chloride was injected into the PENG block 20 mL 0.5% sodium chloride was injected into the Adductor Canal block

Also known as: normal saline
Sham blocks

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years old undergoing unilateral total knee arthroplasty

You may not qualify if:

  • refusal to participate
  • \< 18 yo
  • Chronic opioid use
  • localized infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosia

Interventions

RopivacaineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zbigniew Żaba, Ph.D.

    Department of Emergency Medicine Clinic

    STUDY CHAIR

  • Malgorzata Domagalska, Ph.D.

    Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double-blind, placebo-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

June 18, 2020

Primary Completion

July 20, 2022

Study Completion

August 24, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The data presented in this study are available on request from the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
December 2024
Access Criteria
The data presented in this study are available on request from the corresponding author.

Locations

PL(1)