Clinical trial NCT04443634: Adductor Canal Block (ACB) Versus ACB /Saphenous Block in Patients Undergoing Anterior Cruciate Ligament Repair
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The total dose of morphine consumption in the first 24 hours postoperatively.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Total dose of intraoperative fentanyle adminstration
timeFrame: 2 hours intraoperatively
measure: Numeric Pain Rating Scale
timeFrame: 24 hours postoperative
measure: Failure rate of the block
timeFrame: 24 hours
measure: Block related complications
timeFrame: 1 mounth
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia Department
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.