ACL TearNCT06486246
Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
A study testing Adductor canal block in people with ACL Tear and Pain, Postoperative, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Tear, Pain, Postoperative
- What is being tested?
- Adductor canal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jun 2024to 30 Dec 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
- Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Who cannot join
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
- cancer with chemotherapy
- chronic pain state
- Negative of the patient to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 0836
Xavier Sala-Blanch, MD, 34626353609, xavi.sala.blanch@gmail.com
About this study
Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results.
Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement.
The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.
Read the detailed description
Participants scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be allocated to two groups: Adductor canal block or Genicular nerve block- The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2%. The genicular nerve block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2% in total.
Postoperative analgesia will include analgesia (Dexketoprofen 75 mg during first 24 hours), acetomiophen 1 gr every 8 hours and tramadol for rescue pain.
- Conditions
- ACL Tear, Pain, Postoperative
- Being tested
- Adductor canal block
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockProcedure or surgery
Also called Genicular nerve block
Injection of the local anesthetic prior to the surgery, either in the the adductor canal or in the genicular nerves by the anesthesiologist under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block | Experimental | Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist prior the surgery, after inducction of general anesthesia. Receives: Procedure: Adductor canal block |
| Genicular nerve block | Experimental | Injection of local anaesthetics under ultrasound guidance in the genicular nerves ( Superomedial genicular nerve, superolateral genicular nerve and inferomedial genicular nerve) by the anaesthesiologist prior the surgery, after inducction of general anesthesia. Receives: Procedure: Adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by NRS at PACU
Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain)
Measured: up to 6 hours postoperative
Opioid consumption at PACU
Metadone consumption in mg.
Measured: up to 6 hours postoperative
Secondary outcomes (2)
Pain score at home
Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain)
Measured: up to 24 hours
Quality of rest
Sleep or wake-up during first night (Pain) (Awake because of pain: Yes / NO)
Measured: First night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start26 Jun 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- UNIcenter Non-randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Sala-Blanch, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486246
- Sponsor's protocol ID
- LCAGEN1
- Status last verified
- Jun 2024
- First submitted
- 2 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06486246
- Acronym / sponsor ID
- LCAGEN1
- Conditions
- ACL Tear, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results.
Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement.
The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.
Detailed description
Participants scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be allocated to two groups: Adductor canal block or Genicular nerve block- The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2%. The genicular nerve block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2% in total.
Postoperative analgesia will include analgesia (Dexketoprofen 75 mg during first 24 hours), acetomiophen 1 gr every 8 hours and tramadol for rescue pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- UNIcenter Non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block | Experimental | Procedure: Adductor canal blockInjection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist prior the surgery, after inducction of general anesthesia. |
| Genicular nerve block | Experimental | Procedure: Adductor canal blockInjection of local anaesthetics under ultrasound guidance in the genicular nerves ( Superomedial genicular nerve, superolateral genicular nerve and inferomedial genicular nerve) by the anaesthesiologist prior the surgery, after inducction of general anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Key exclusion criteria (8 listed)
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
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 |
|---|---|---|
| Adductor canal blockAlso: Genicular nerve blockInjection of the local anesthetic prior to the surgery, either in the the adductor canal or in the genicular nerves by the anesthesiologist under ultrasound guidance. | Procedure or surgery | Adductor canal block, Genicular nerve block |
Primary outcome
Pain assessed by NRS at PACU
Time frame: up to 6 hours postoperative
Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain)
Opioid consumption at PACU
Time frame: up to 6 hours postoperative
Metadone consumption in mg.
2 secondary outcomes
Pain score at home
Time frame: up to 24 hours
Quality of rest
Time frame: First night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor canal block in people with ACL Tear and Pain, Postoperative, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by NRS at PACU (time frame: up to 6 hours postoperative). The study lists 2 primary outcomes in all. 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 3 Jul 2024.