Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intra-articular injection
genicular nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Revision knee arthroscopy,
- previous surgery or trauma to the knee,
- drug allergy,
- regular narcotic use,
- renal &/ or hepatic impairments,
- neuromuscular diseases
- and coagulopathy disorders.
Sites / Locations
- Tarek Abdel HayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intra-articular injection group
genicular nerve block group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
first time of rescue analgesia
first time of rescue morphine analgesia
Secondary Outcome Measures
Number of patients received rescue analgesia.
number of patients required postoperative rescue morphine analgesis
Total doses of postoperative morphine consumption
Total doses of postoperative morphine consumption as rescue analgesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04656743
Brief Title
Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
Official Title
Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Arthroscopic knee surgery has become increasingly popular in modern orthopedics. Post-operative knee pain management has become a challenge to provide early relief and pain-free postoperative care to the patient.
Pain management has become a priority for management as a daycare procedure. Patients operated as a daycare procedure should have minimal postoperative pain which influences the timing of discharge. Pain is due to multifactorial causes such as irritation of free nerve endings of the joint capsule, synovial tissue, anterior fat pad.
Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves patient satisfaction.
Postoperative pain after knee arthroscopy is commonly moderate to severe and can affect the patient's activity level and satisfaction.
In an effort to provide safe, effective, and long-lasting post-arthroscopy pain relief, many drug regimens were injected intra-articularly including local anesthetics alone or with additive drugs to prolong and improve the quality of postoperative analgesia.
Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intra-articular injection group
Arm Type
Experimental
Arm Description
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.
Arm Title
genicular nerve block group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intra-articular injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
genicular nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
first time of rescue analgesia
Description
first time of rescue morphine analgesia
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Number of patients received rescue analgesia.
Description
number of patients required postoperative rescue morphine analgesis
Time Frame
postoperative first day
Title
Total doses of postoperative morphine consumption
Description
Total doses of postoperative morphine consumption as rescue analgesia
Time Frame
postoperative first day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Revision knee arthroscopy,
previous surgery or trauma to the knee,
drug allergy,
regular narcotic use,
renal &/ or hepatic impairments,
neuromuscular diseases
and coagulopathy disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tarek mostafa, MD
Phone
0201003591332
Email
dr.tarek311@yahoo.com
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek abdel hay mostafa, MD
Phone
0201003591332
Email
dr.tarek311@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
We'll reach out to this number within 24 hrs