Postoperative PainNCT04656743
Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
A study testing intra-articular injection and genicular nerve block in people with Postoperative Pain, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- intra-articular injection and genicular nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Revision knee arthroscopy,
- previous surgery or trauma to the knee,
- drug allergy,
- regular narcotic use,
- renal \&/ or hepatic impairments,
- neuromuscular diseases
- and coagulopathy disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- intra-articular injection, genicular nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular injectionProcedure or surgery
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.
genicular nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: genicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
first time of rescue analgesia
first time of rescue morphine analgesia
Measured: postoperative first day
Secondary outcomes (2)
Number of patients received rescue analgesia.
number of patients required postoperative rescue morphine analgesis
Measured: postoperative first day
Total doses of postoperative morphine consumption
Total doses of postoperative morphine consumption as rescue analgesia
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start10 Dec 2020
- Primary completion1 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656743
- Sponsor's protocol ID
- pain in knee arthroscopy
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT04656743
- Acronym / sponsor ID
- pain in knee arthroscopy
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-articular injection group | Experimental | Procedure: intra-articular injectionwill 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. |
| genicular nerve block group | Experimental | Procedure: genicular nerve blockwill 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Revision knee arthroscopy,
- previous surgery or trauma to the knee,
- drug allergy,
- regular narcotic use,
- renal \&/ or hepatic impairments,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-articular injectionThe 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. | Procedure or surgery | intra-articular injection group |
| genicular nerve blockThe 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. | Procedure or surgery | genicular nerve block group |
Primary outcome
first time of rescue analgesia
Time frame: postoperative first day
first time of rescue morphine analgesia
2 secondary outcomes
Number of patients received rescue analgesia.
Time frame: postoperative first day
Total doses of postoperative morphine consumption
Time frame: postoperative first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular injection and genicular nerve block in people with Postoperative Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first time of rescue analgesia (time frame: postoperative first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.