NCT06802419

Brief Summary

This study aims to evaluate the effect of Continuous Adductor Canal Block only versus adding posterior knee block, known as the Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block with Continuous Adductor Canal Block (CACB) after arthroscopic knee surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 21, 2025

Last Update Submit

January 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    The degree of pain will be assessed using the Visual Analogue Scale (VAS). VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

    24 hours postoperatively

Secondary Outcomes (4)

  • Total Nalbuphine consumption

    24 hours postoperatively

  • Straight leg rise

    24 hours postoperatively

  • Range of motion

    24 hours postoperatively

  • Rate of complications

    24 hours postoperatively

Study Arms (2)

Group 1

EXPERIMENTAL

Patients will receive continuous adductor canal block.

Other: Continuous adductor canal block

Group 2

EXPERIMENTAL

Patients will receive Continuous Adductor Canal Block with additional Infiltration between The Popliteal Artery and Capsule of The Knee

Other: Continuous Adductor Canal Block with additional Infiltration between The Popliteal Artery and Capsule

Interventions

Patients will receive continuous adductor canal block.

Group 1

Patients will receive Continuous Adductor Canal Block with additional Infiltration between The Popliteal Artery and Capsule of The Knee

Group 2

Eligibility Criteria

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

You may qualify if:

  • Age from 21 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status Class I to II.
  • Patients with successful spinal anesthesia.
  • Patients scheduled for elective arthroscopic knee surgery for anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) repair.

You may not qualify if:

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Polytrauma patients having lower limb fractures.
  • Patients with pre-existing myopathy or neuropathy on the operating limb.
  • Patients with diabetes mellitus.
  • Psychiatric disorder.
  • Morbid obesity \[body mass index (BMI) \> 45kg/m2\].
  • Complicated Surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

Nada E Hussein, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 31, 2025

Study Start

January 30, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations