- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486246
Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 0836
- Recruiting
- Hospital Clinic
-
Contact:
- Xavier Sala-Blanch, MD
- Phone Number: 34626353609
- Email: xavi.sala.blanch@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adductor canal block
Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist prior the surgery, after inducction of general anesthesia.
|
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.
Other Names:
|
|
Experimental: Genicular nerve block
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
up to 6 hours postoperative
|
|
Opioid consumption at PACU
Time Frame: up to 6 hours postoperative
|
Metadone consumption in mg.
|
up to 6 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score at home
Time Frame: up to 24 hours
|
Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain)
|
up to 24 hours
|
|
Quality of rest
Time Frame: First night
|
Sleep or wake-up during first night (Pain) (Awake because of pain: Yes / NO)
|
First night
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCAGEN1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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