NCT06404658

Brief Summary

One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

April 8, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

April 8, 2024

Last Update Submit

May 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS score

    Measuring pain intensity regarding mean visual analogue score (VAS score ) ranging from 0 (no pain) to 10 (the worst imaginable pain.

    48 hour

Secondary Outcomes (5)

  • Ambulatory score

    Within 48 hour

  • Time of first rescue analgesia

    within 24 hour

  • Total opioid consumption post operative

    Within 24 hour

  • Incidence of occurrence of systemic toxicity

    Within 24 hour

  • The length of hospital stay .

    within one week

Study Arms (3)

Control group

NO INTERVENTION

did not receive any block just spinal anathesia.

Genicular nerve block

ACTIVE COMPARATOR

patients who receive Genicular nerve block with spinal anathesia .

Procedure: Genicular nerve block

IPACK block

ACTIVE COMPARATOR

patients who receive IPACK block with spinal anathesia.

Procedure: Genicular nerve block

Interventions

patients who receive Genicular nerve block with spinal anathesia .

Genicular nerve blockIPACK block

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) \<40 kg/m2

You may not qualify if:

  • Patients were excluded if they refused consent.
  • Patients who are Not cooperative.
  • BMI \>40 kg/m2.
  • Allergy to local anesthetics.
  • Patients with anticoagulation or bleeding problems.
  • Previous nerve dysfunction.
  • Physical status ASA class IV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef University Hospital

Benisuef, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Mariana AbdElsayed Mansour

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anaesthesia, surgical intensive care and pain managment

Study Record Dates

First Submitted

April 8, 2024

First Posted

May 8, 2024

Study Start

May 12, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations