NCT05684107

Brief Summary

Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major 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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

December 20, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

IPACK , Sciatic nerve block , adductor canal block

Outcome Measures

Primary Outcomes (1)

  • change of visual analogue scale

    a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome

    change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement

Secondary Outcomes (2)

  • time for fisrt analgesic request

    up to 48 hours

  • total morphine consumption

    up to 48 hours

Study Arms (3)

IPACK block

ACTIVE COMPARATOR
Procedure: IPACK block

sciatic nerve block

ACTIVE COMPARATOR
Procedure: sciatic nerve block

adductor canal block

ACTIVE COMPARATOR
Procedure: adductor canal block

Interventions

IPACK blockPROCEDURE

the probe is applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe is slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches is advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reached the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn

IPACK block

the transducer is placed anteromedially, approximately at the junction between the middle and distal third of the thigh or somewhat lower. The saphenous nerve block should be performed at the most distal level where the artery still lies immediately deep to the sartorius muscle, thus minimizing the amount of motor nerve block of the vastus medialis; an adductor canal nerve block is typically performed more proximally, around the mid-thigh level. The needle is inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip is visualized anterior to the artery and after careful aspiration, 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn

adductor canal block

patient in a supine position with the hip and knee on the operated side flexed and the leg externally rotated at approximately 45 degrees. The ultrasound transducer is first positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location is then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter is obtained. a spinal needle 22G x 3.5 inches is advanced parallel and in line with the ultrasound transducer while the sciatic nerve is kept in the middle of the screen. The needle is advanced slowly under real-time ultrasound guidance until it is near the nerve then negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn

sciatic nerve block

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II physical status
  • undergoing elective major knee surgery

You may not qualify if:

  • refusal of the patients to give informed consent,
  • preexisting coagulation disorders,
  • known allergies to aminoamide local anesthetics,
  • local infection at the site of the block,
  • morbid obesity,
  • hepatic and renal diseases
  • patients with psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

mostafa saieed saieed mansour, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 13, 2023

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations