<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443634</url>
  </required_header>
  <id_info>
    <org_study_id>N-27-2017</org_study_id>
    <nct_id>NCT04443634</nct_id>
  </id_info>
  <brief_title>Adductor Canal Block (ACB) Versus ACB /Saphenous Block in Patients Undergoing Anterior Cruciate Ligament Repair</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or&#xD;
      saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries&#xD;
      potential benefits that encourage anesthesiologists to do it. It has a motor sparing&#xD;
      property. Injection of local anesthetics in this lengthy canal that contains a variable&#xD;
      amount of connective or fibrous tissue might lead to a patchy distribution of local&#xD;
      anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important&#xD;
      nerve in knee innervations) cannot be excluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study is to compare the efficacy of the adductor canal block to the combined&#xD;
      adductor canal block and saphenous nerve block at the distal third of thigh in the&#xD;
      intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following&#xD;
      knee arthroscopic anterior cruciate ligament repair.&#xD;
&#xD;
      After written informed consent, patients will be randomized in three groups:&#xD;
&#xD;
      Group (Adductor 20): Ultrasound guided adductor canal block will be performed with injection&#xD;
      of 20 ml bupivcaine 0.5%.&#xD;
&#xD;
      Group (Adductor 30) Ultrasound guided adductor canal block will be performed with injection&#xD;
      of 30 ml bupivacaine 0.5%. Group (Adductor/saphenous ): Ultrasound guided adductor canal&#xD;
      block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound&#xD;
      guided saphenous&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The total dose of morphine consumption in the first 24 hours postoperatively.</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>The total amount of morphine consumption in the first 24 hours postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of intraoperative fentanyle adminstration</measure>
    <time_frame>2 hours intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>24 hours postoperative</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure rate of the block</measure>
    <time_frame>24 hours</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block related complications</measure>
    <time_frame>1 mounth</time_frame>
    <description>o The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Adductor 20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adductor 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Guided Adductor Canal Block</intervention_name>
    <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</description>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
    <arm_group_label>Adductor 20</arm_group_label>
    <arm_group_label>Adductor 30</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound Guided Saphenous Nerve Block</intervention_name>
    <description>It will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh.&#xD;
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.</description>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <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%.&#xD;
Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control.&#xD;
Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.</description>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
    <arm_group_label>Adductor 20</arm_group_label>
    <arm_group_label>Adductor 30</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 20 ml</intervention_name>
    <description>20ml bupivacaine 0.5%</description>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
    <arm_group_label>Adductor 20</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 30ml</intervention_name>
    <description>30ml bupivacaine 0.5%</description>
    <arm_group_label>Adductor 30</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 10ml</intervention_name>
    <description>10ml bupivacaine 0.5%</description>
    <arm_group_label>Adductor /Saphenous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for knee orthopedic ( ACL repair)&#xD;
&#xD;
          -  Physical status ASA I, II.&#xD;
&#xD;
          -  Body mass index (BMI): &gt; 20 kg/m2 and &lt; 35 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with known sensitivity or contraindication to drug used in the study (local&#xD;
             anesthetics, opioids).&#xD;
&#xD;
               -  History of psychological disorders and/or chronic pain.&#xD;
&#xD;
               -  Contraindication to regional anesthesia e.g. local sepsis, pre- existing&#xD;
                  peripheral neuropathies and coagulopathy.&#xD;
&#xD;
               -  Infection of the skin at the site of needle puncture area.&#xD;
&#xD;
               -  Patient refusal.&#xD;
&#xD;
               -  Severe respiratory or cardiac disorders.&#xD;
&#xD;
               -  Advanced liver or kidney disease.&#xD;
&#xD;
               -  Pregnancy.&#xD;
&#xD;
               -  Patient with surgery duration more than two hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bassant abdelhamid</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bassant abdelhamid, M.D.</last_name>
    <phone>01224254012</phone>
    <email>bassantmohamed197@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anesthesia Department</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bassant abdelhamid</last_name>
      <phone>01224254012</phone>
      <email>bassantmohamed197@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <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>
    <PMID>20889937</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20098137</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25386752</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19916251</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Bassant M. Abdelhamid</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443634
org study id: N-27-2017
nct id: NCT04443634
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: The total dose of morphine consumption in the first 24 hours postoperatively.
time frame: 24 hours postoperative
description: The total amount of morphine consumption in the first 24 hours postoperatively.
measure: Total dose of intraoperative fentanyle adminstration
time frame: 2 hours intraoperatively
measure: Numeric Pain Rating Scale
time frame: 24 hours postoperative
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.
measure: Failure rate of the block
time frame: 24 hours
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.
measure: Block related complications
time frame: 1 mounth
description: o The incidence of vascular puncture, and presence or absence of saphenous nerve neuritis during the first month after surgery were also recorded
arm group label: Adductor 20
arm group type: Experimental
description: Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine
arm group label: Adductor 30
arm group type: Experimental
description: Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine
arm group label: Adductor /Saphenous
arm group type: Experimental
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: Ultrasound Guided Adductor Canal Block
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
arm group label: Adductor /Saphenous
arm group label: Adductor 20
arm group label: Adductor 30
intervention type: Procedure
intervention name: Ultrasound Guided Saphenous Nerve Block
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.
arm group label: Adductor /Saphenous
intervention type: Procedure
intervention name: General anesthesia
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.
arm group label: Adductor /Saphenous
arm group label: Adductor 20
arm group label: Adductor 30
intervention type: Drug
intervention name: Bupivacaine 20 ml
description: 20ml bupivacaine 0.5%
arm group label: Adductor /Saphenous
arm group label: Adductor 20
intervention type: Drug
intervention name: Bupivacaine 30ml
description: 30ml bupivacaine 0.5%
arm group label: Adductor 30
intervention type: Drug
intervention name: Bupivacaine 10ml
description: 10ml bupivacaine 0.5%
arm group label: Adductor /Saphenous
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bassant abdelhamid
role: Principal Investigator
affiliation: Cairo University
last name: Bassant abdelhamid, M.D.
phone: 01224254012
email: bassantmohamed197@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
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.
PMID: 20889937
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.
PMID: 20098137
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.
PMID: 25386752
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.
PMID: 19916251
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Bassant M. Abdelhamid
investigator title: associate professor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No