NCT07046377

Brief Summary

Comparative Study between Adductor canal block combined with infiltration OF The interspace between popliteal artery and the capsule of the knee block versus genicular nerves Block combined with IPACK in Postoperative analgesia after knee replacement surgery

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

July 1, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 6, 2025

Last Update Submit

June 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1- Comparing both groups regarding the time needed ( in hours) for the first call rescue analgesia post operatively.

    Total knee replacement (TKR) is a well-known popular surgical procedure for knee diseases, including end-stage knee osteoarthritis that causes severe postoperative pain and prolonged immobility. Acute pain control can be provided with multimodal analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. However, NSAIDs cause many side effects as peptic ulcer and gastritis, also opioids have gastrointestinal side effects as constipation, nausea and vomiting as well as respiratory depression. Regional analgesia has been used as another modality to provide sufficient perioperative pain relief with minimal opioid consumption to avoid it's adverse effects peripheral nerve blocks (PNBs) is a common practice in orthopedic surgery. PNBs provide excellent pain management after TKA, promote early mobilization, and reduce the consumption of opioids, the incidence of opioid-related adverse effects, and the hospital stay

    5 minutes after ending of operation

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Adductor canal block + IPACK group

Procedure: ACB - IPACK

Group 2

ACTIVE COMPARATOR

Genicular nerves block + IPACK block.

Procedure: GNB - IPACK

Interventions

ACB - IPACKPROCEDURE

will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.

Group 1
GNB - IPACKPROCEDURE

will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.

Group 2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-85 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status Class I to III.
  • Patients scheduled for unilateral TKA under spinal anesthesia.

You may not qualify if:

  • Patient's refusal.
  • American Society of Anesthesiologists (ASA) Physical Status Class above III.
  • local infection.
  • History of allergy to the medications used in the study. 5. Psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mai Ma Abd ElAziz, MBBCH

    Ain Shams University

    PRINCIPAL INVESTIGATOR
  • Mai Ma Abd ElAziz Ibrahim, MBBCH

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

July 1, 2025

Study Start

January 29, 2025

Primary Completion

July 29, 2025

Study Completion

July 29, 2025

Last Updated

July 1, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All data will be shared once Study is completed

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Before 1/2026
Access Criteria
Free

Locations