- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04443634
Adductor Canal Block (ACB) Versus ACB /Saphenous Block in Patients Undergoing Anterior Cruciate Ligament Repair
Presurgical Adductor Canal Block (ACB) Versus ACB and Distal (Intermuscular) Saphenous Nerve Block in Patients Undergoing Anterior Cruciate Ligament Repair Under General Anaesthesia: Randomised Controlled Trial.
Study Overview
Status
Conditions
Detailed Description
Aim of the study is to compare the efficacy of the adductor canal block to the combined adductor canal block and saphenous nerve block at the distal third of thigh in the intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following knee arthroscopic anterior cruciate ligament repair.
After written informed consent, patients will be randomized in three groups:
Group (Adductor 20): Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivcaine 0.5%.
Group (Adductor 30) Ultrasound guided adductor canal block will be performed with injection of 30 ml bupivacaine 0.5%. Group (Adductor/saphenous ): Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound guided saphenous
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bassant abdelhamid, M.D.
- Phone Number: 01224254012
- Email: bassantmohamed197@yahoo.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Anesthesia Department
-
Contact:
- Bassant abdelhamid
- Phone Number: 01224254012
- Email: bassantmohamed197@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Scheduled for knee orthopedic ( ACL repair)
- Physical status ASA I, II.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Exclusion Criteria:
• Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Infection of the skin at the site of needle puncture area.
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Pregnancy.
- Patient with surgery duration more than two hours.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adductor 20
Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine
|
It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe.
Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery.
From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle.
With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal.
the volume of local anesthetic will be selected according to the studied group
General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%. Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control. Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.
20ml bupivacaine 0.5%
|
Experimental: Adductor 30
Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine
|
It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe.
Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery.
From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle.
With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal.
the volume of local anesthetic will be selected according to the studied group
General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%. Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control. Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.
30ml bupivacaine 0.5%
|
Experimental: Adductor /Saphenous
Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.
|
It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe.
Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery.
From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle.
With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal.
the volume of local anesthetic will be selected according to the studied group
General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%. Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control. Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.
20ml bupivacaine 0.5%
It will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh. The US probe will be positioned on the front of the lower part of the thigh immediately above the patella to see both the patella (hyperechoic curved line) and vastus medialis infront of it (closer to skin). The probe is then moved medially over the vastus medialis till we see the end of the muscle and we see an intermuscular plane between it and Sartorius muscle. A 20 guage spinal needle will be then passed in an in plane direction within the substance of vastus medialis muscle and then pass within the vastus medialis until it faces the intermuscular plane between VM muscle and Sartorius. Once the needle tip is located in close proximity to the target structures, gentle aspiration will be performed followed by 20 ml local anesthetic will be injected.
10ml bupivacaine 0.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total dose of morphine consumption in the first 24 hours postoperatively.
Time Frame: 24 hours postoperative
|
The total amount of morphine consumption in the first 24 hours postoperatively.
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total dose of intraoperative fentanyle adminstration
Time Frame: 2 hours intraoperatively
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2 hours intraoperatively
|
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Numeric Pain Rating Scale
Time Frame: 24 hours postoperative
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Numeric Pain Rating Scale, both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24 hours postoperatively.
It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
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24 hours postoperative
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Failure rate of the block
Time Frame: 24 hours
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• Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
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24 hours
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Block related complications
Time Frame: 1 mounth
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o The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded
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1 mounth
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bassant abdelhamid, Cairo University
Publications and helpful links
General Publications
- Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Ilfeld BM, Moeller LK, Mariano ER, Loland VJ, Stevens-Lapsley JE, Fleisher AS, Girard PJ, Donohue MC, Ferguson EJ, Ball ST. Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb;112(2):347-54. doi: 10.1097/ALN.0b013e3181ca4e5d.
- Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- N-27-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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