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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Adductor Canal Block
Ultrasound Guided Saphenous Nerve Block
General anesthesia
Bupivacaine 20 ml
Bupivacaine 30ml
Bupivacaine 10ml
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anesthesia DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Adductor 20

Adductor 30

Adductor /Saphenous

Arm Description

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

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

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%.

Outcomes

Primary Outcome Measures

The total dose of morphine consumption in the first 24 hours postoperatively.
The total amount of morphine consumption in the first 24 hours postoperatively.

Secondary Outcome Measures

Total dose of intraoperative fentanyle adminstration
Numeric Pain Rating Scale
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.
Failure rate of the block
• 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.
Block related complications
o The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded

Full Information

First Posted
June 18, 2020
Last Updated
June 26, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04443634
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
September 25, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adductor 20
Arm Type
Experimental
Arm Description
Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine
Arm Title
Adductor 30
Arm Type
Experimental
Arm Description
Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine
Arm Title
Adductor /Saphenous
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Adductor Canal Block
Intervention Description
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
Intervention Name(s)
Ultrasound Guided Saphenous Nerve Block
Intervention Description
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
Intervention Name(s)
General anesthesia
Intervention Description
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
Drug
Intervention Name(s)
Bupivacaine 20 ml
Intervention Description
20ml bupivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 30ml
Intervention Description
30ml bupivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 10ml
Intervention Description
10ml bupivacaine 0.5%
Primary Outcome Measure Information:
Title
The total dose of morphine consumption in the first 24 hours postoperatively.
Description
The total amount of morphine consumption in the first 24 hours postoperatively.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Total dose of intraoperative fentanyle adminstration
Time Frame
2 hours intraoperatively
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
24 hours postoperative
Title
Failure rate of the block
Description
• 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.
Time Frame
24 hours
Title
Block related complications
Description
o The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded
Time Frame
1 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant abdelhamid, M.D.
Phone
01224254012
Email
bassantmohamed197@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia Department
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20889937
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.
Results Reference
background
PubMed Identifier
20098137
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.
Results Reference
background
PubMed Identifier
25386752
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.
Results Reference
background
PubMed Identifier
19916251
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.
Results Reference
background

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

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