NCT07058493

Brief Summary

Dexmedetomidine used as an Additive for Ipack Block in Knee Surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

May 5, 2024

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale at rest score during first postoperative 48 hours

    Visual Analog Scale at rest during first postoperative 48 hours a line 10centimeters long from zero to10 where 10 is the worst pain ever

    48 postoperative hours

Secondary Outcomes (6)

  • Visual Analog Scale at rest and during movement at 30 minuts, 2, 8, 16, 24, 36, and 48 hours

    48 postoperative hours

  • Duration of the block

    48 hours

  • Heart Rate

    48 hours

  • Mean Arterial Pressure

    48 hours

  • Block performance time in minutes

    preoperative

  • +1 more secondary outcomes

Study Arms (2)

Bupivacaine

EXPERIMENTAL

IPACK block with 20ml bupivacaine 0.25% alone. .

Drug: Bupivacaine

Dexmedetomidine

EXPERIMENTAL

IPACK block with 20 ml of bupivacaine 0.25% with dexmedetomidine 100 μg as adjuvant.

Drug: Dexmedetomidine

Interventions

dexmedetomidine 100 μg as adjuvant to IPACK block with 20 ml of bupivacaine 0.25%.

Dexmedetomidine

20 ml of bupivacaine 0.25%.

Bupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • ASA I, II .patients undergoing knee surgeries.

You may not qualify if:

  • patient Refusal
  • bleeding disorders
  • skin lesion
  • infection
  • known allergy
  • contradictions of spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dalia K Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University

Study Record Dates

First Submitted

May 5, 2024

First Posted

July 10, 2025

Study Start

January 2, 2024

Primary Completion

July 10, 2024

Study Completion

July 30, 2024

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations