Adductor Canal Block (ACB) Versus ACB /Saphenous Block in Patients Undergoing Anterior Cruciate Ligament Repair

NCT ID: NCT04443634

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2020-10-01

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

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adductor 20

Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine

Group Type: EXPERIMENTAL

Ultrasound Guided Adductor Canal Block

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Bupivacaine 20 ml

Intervention Type: DRUG

20ml bupivacaine 0.5%

Adductor 30

Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine

Group Type: EXPERIMENTAL

Ultrasound Guided Adductor Canal Block

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Bupivacaine 30ml

Intervention Type: DRUG

30ml bupivacaine 0.5%

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%.

Group Type: EXPERIMENTAL

Ultrasound Guided Adductor Canal Block

Intervention Type: PROCEDURE

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

Ultrasound Guided Saphenous Nerve Block

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Bupivacaine 20 ml

Intervention Type: DRUG

20ml bupivacaine 0.5%

Bupivacaine 10ml

Intervention Type: DRUG

10ml bupivacaine 0.5%

Interventions

Ultrasound Guided Adductor Canal Block

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

Intervention Type: PROCEDURE

Ultrasound Guided Saphenous Nerve Block

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.

Intervention Type: PROCEDURE

General anesthesia

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.

Intervention Type: PROCEDURE

Bupivacaine 20 ml

20ml bupivacaine 0.5%

Intervention Type: DRUG

Bupivacaine 30ml

30ml bupivacaine 0.5%

Intervention Type: DRUG

Bupivacaine 10ml

10ml bupivacaine 0.5%

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Bassant M. Abdelhamid

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bassant abdelhamid

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Anesthesia Department

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Bassant abdelhamid, M.D.

Role: CONTACT

bassantmohamed197@yahoo.com

01224254012

Facility Contacts

Bassant abdelhamid

Role: primary

bassantmohamed197@yahoo.com

01224254012

References

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.

Reference Type: BACKGROUND

PMID: 20889937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20098137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25386752 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19916251 (View on PubMed)

Other Identifiers

N-27-2017

Identifier Type: -

Identifier Source: org_study_id