NCT04656743

Brief Summary

This prospective double-blinded randomized study will be conducted to compare ultrasound-guided intra-articular injection and ultrasound-guided genicular nerve block for postoperative analgesia after knee arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable postoperative-pain

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

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

November 30, 2020

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • first time of rescue analgesia

    first time of rescue morphine analgesia

    postoperative first day

Secondary Outcomes (2)

  • Number of patients received rescue analgesia.

    postoperative first day

  • Total doses of postoperative morphine consumption

    postoperative first day

Study Arms (2)

intra-articular injection group

EXPERIMENTAL

will receive ultrasound guided intraarticular injection consisting of 20 mL of 0.25% bupivacaine before surgical procedure. The surgical procedure will be started 30 min after intraarticular injection.

Procedure: intra-articular injection

genicular nerve block group

EXPERIMENTAL

will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% before surgical procedure. The surgical procedure will be started 30 min after genicular nerve block.

Procedure: genicular nerve block

Interventions

The injection will be performed under ultrasound guidance by placing the patient's knee in approximately 90° of flexion with the leg hanging off the side of the bed (left). A high-frequency linear transducer ultrasound probe is placed in the superolateral corner of the patella, directed medially toward the patellofemoral joint space. In the extended leg, from anterior to posterior, the right image shows the quadriceps femoris tendon (QF), suprapatellar fat pad (SF), suprapatellar bursa (SB), prefemoral fat pad (PF), and femur (F). When the knee is flexed to 90°, the size of the suprapatellar bursa image is increased. Using an in-plane approach, the needle will be directed into the suprapatellar joint space, and 20 ml of bupivacaine 0.25% will be injected.

intra-articular injection group

The transducer will be first placed parallel to the long bone shaft and moved up or down to identify the epicondyle of the long bone. The genicular arteries will be identified near the periosteal areas, confirmed by color Doppler ultrasound. Accordingly, genicular nerve block target points should be next to each genicular artery. After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view. a gentle aspiration will be performed and a 2 mL injection volume will be administered.

genicular nerve block group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • scheduled for unilateral knee arthroscopy surgery (ligament reconstruction, cartilage procedures, and diagnostic arthroscopic procedures)
  • aged between 18 and 50 years
  • of both genders,
  • have ASA physical status I and II.

You may not qualify if:

  • Revision knee arthroscopy,
  • previous surgery or trauma to the knee,
  • drug allergy,
  • regular narcotic use,
  • renal \&/ or hepatic impairments,
  • neuromuscular diseases
  • and coagulopathy disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

December 10, 2020

Primary Completion

March 1, 2024

Study Completion

April 15, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations