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.
1 other identifier
interventional
88
1 country
1
Brief Summary
Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jun 2020
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
June 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJune 29, 2020
June 1, 2020
3 months
June 18, 2020
June 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The total dose of morphine consumption in the first 24 hours postoperatively.
The total amount of morphine consumption in the first 24 hours postoperatively.
24 hours postoperative
Secondary Outcomes (4)
Total dose of intraoperative fentanyle adminstration
2 hours intraoperatively
Numeric Pain Rating Scale
24 hours postoperative
Failure rate of the block
24 hours
Block related complications
1 mounth
Study Arms (3)
Adductor 20
EXPERIMENTALUltrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine
Adductor 30
EXPERIMENTALUltrasound guided adductor canal block will be performed with injection of 30ml bupivacaine
Adductor /Saphenous
EXPERIMENTALUltrasound 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%.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- Scheduled for knee orthopedic ( ACL repair)
- Physical status ASA I, II.
- Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Anesthesia Department
Cairo, Egypt
Related Publications (4)
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.
PMID: 20889937BACKGROUNDIlfeld 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.
PMID: 20098137BACKGROUNDJaeger 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.
PMID: 25386752BACKGROUNDManickam 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.
PMID: 19916251BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bassant abdelhamid
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 23, 2020
Study Start
June 25, 2020
Primary Completion
September 25, 2020
Study Completion
October 1, 2020
Last Updated
June 29, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share