NCT07382297

Brief Summary

the aim of this study is to determine the analgesic effect of iPACK in combination to ACB after the excision of tumors around the Knee regarding the following:

  • Time to the 1st rescue analgesia.
  • Postoperative morphine consumption.
  • Postoperative visual analogue scale (VAS). This study will include patients, aged 18 to 65 years, belonging to the American Society of Anesthesiologists (ASA) physical status II to IV , undergoing excision of tumors around the knee under spinal anesthesia. Patients will be randomly allocated Group iPACK plus Adductor canal block (ACB) : patients will receive ACB plus iPACK block.
  • Control group : patients will not receive any block but will take morphine 3mg bolus at VAS more than 4 and regular NSAIDS and paracetamol iv.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
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 Progress83%
Aug 2025Jun 2026

Study Start

First participant enrolled

August 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 2, 2026

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

January 25, 2026

Last Update Submit

January 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time to the 1st rescue analgesia

    24 hours postoperative

Secondary Outcomes (2)

  • Total morphine consumption

    first 24 hour

  • pain score ( visual analogue scale)

    at 2 hours ,4 hours,6 hours, 12 hours,18 hours and 24 h postoperatively

Study Arms (2)

adductor canal block with iPACK

ACTIVE COMPARATOR

The adductor canal will be identified. a spinal needle 22 gauge x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique, and 15ml of 0.5% bupivacaine will be injected then IPACK block will be performed The probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe will be 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 will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and 15ml of 0.5% bupivacaine will be injected incrementally as the needle will be withdrawn.

Procedure: adductor canal block with iPACK

control group

OTHER

visualizing the adductor canal without doing any block for the control group

Other: control group

Interventions

The adductor canal will be identified. a spinal needle 22 gauge x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique ,and 15ml of 0.5% bupivacaine will be injected then IPACK block will be performed. The probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe will be 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 will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and 15ml of 0.5% bupivacaine will be injected incrementally as the needle will be withdrawn

adductor canal block with iPACK

The probe will be positioned at the midpoint between the anterior superior iliac spine and the upper pole of the patella. The adductor canal, which is a hyperechoic structure situated beneath the sartorius muscle, will be identified but no block will be done

control group

Eligibility Criteria

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

You may qualify if:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • American Society of Anesthesiologists (ASA) physical status II-IV.
  • Patients undergoing excision of tumors around the knee under spinal anesthesia

You may not qualify if:

  • Patient refusal.
  • Neuromuscular disorders
  • Allergy to local anesthetics
  • Previous history of knee surgery
  • Patients with a prior knee infection
  • Contraindications to spinal anesthesia as coagulopathies and severe aortic stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National cancer institute

Cairo, 11769, Egypt

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ghada Gamal Eldin Elsayed, MD

    National Cancer Institute (NCI)

    STUDY DIRECTOR

Central Study Contacts

Norma Osama Abdallah Zayed, MD

CONTACT

Fady Attef, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

August 15, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 2, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations