NCT05813834

Brief Summary

Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay. in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

April 3, 2023

Last Update Submit

November 12, 2024

Conditions

Genicular Nerve Block for Pain in ACL Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • post operative VAS

    vas score

    24 hours

Secondary Outcomes (4)

  • total morphine consumption

    24 hours

  • time to first morphine analgesia

    24 hours

  • range of motion

    24 hours

  • post operative MAP

    24 hours

Study Arms (2)

genicular nerve block group

ACTIVE COMPARATOR

patients will receive genicular nerves block

Procedure: Genicular Nerves Block

control group

NO INTERVENTION

patients will not receive genicular nerves block

Interventions

Genicular Nerves BlockPROCEDURE

US guided genicular nerves block

genicular nerve block group

Eligibility Criteria

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

You may qualify if:

  • both genders
  • age 18 - 65
  • ASA i, ii, iii

You may not qualify if:

  • ROM less than 90
  • advanced renal or liver diseases
  • patient refusal
  • substance abuse
  • site infection
  • known sensitivity to any of study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Cairo university

Cairo, Egypt

Location

Study Officials

  • Dalia K Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Genicular Nerves Block
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

April 3, 2023

First Posted

April 14, 2023

Study Start

June 1, 2023

Primary Completion

February 15, 2024

Study Completion

March 30, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)