NCT04995861

Brief Summary

A comparison between The analgesic efficacy of adductor canal block alone and adductor canal with IPACK (interspace between popliteal artery and capsule of the knee) block for knee surgeries

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

Study Start

First participant enrolled

April 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

July 24, 2021

Last Update Submit

July 18, 2022

Conditions

Nerve Blocks

Outcome Measures

Primary Outcomes (1)

  • Assessment of post operative pain

    Using visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain)

    One year

Secondary Outcomes (1)

  • Range of movement and ambulation

    One year

Study Arms (2)

Group A (adductor canal only)

ACTIVE COMPARATOR

Will recieve adductor canal block only

Procedure: Adductor canal block and IPACK block

Group AB (adductor canal + IPACK)

ACTIVE COMPARATOR

Will recieve both adductor canal block and IPACK

Procedure: Adductor canal block and IPACK block

Interventions

Adductor canal block and IPACK blockPROCEDURE

Peripheral nerve blocks

Group A (adductor canal only)Group AB (adductor canal + IPACK)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing knee surgery i.e. arthroscopy, total knee replacement, ACL repair.
  • ASA physical status I to III
  • Sex (males and females)
  • Age 21-70 years.

You may not qualify if:

  • Hypersensitivity to local anesthetics. Preexisting peripheral neuropathy. Infection near site of infections e.g. osteomyelitis, septic knee joint. Etc. Patient refusal. PAny contraindications for spinal anesthesia. ( eg: coagulopathy, use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of anesthesia , intensive care and pain management

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 9, 2021

Study Start

April 20, 2021

Primary Completion

September 20, 2022

Study Completion

September 30, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)