<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/NCT03824665</url>
  </required_header>
  <id_info>
    <org_study_id>Nalbuphine Versus Fentanyl</org_study_id>
    <nct_id>NCT03824665</nct_id>
  </id_info>
  <brief_title>Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture</brief_title>
  <official_title>Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture for Peribulbar Block During Posterior Segment Surgery in Adult Patients a Prospective Randomized Clinical 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>Yes</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>
      Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal&#xD;
      anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration&#xD;
      of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg&#xD;
      Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block&#xD;
      undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl&#xD;
      20 μg to LAM and LAM alone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      120 patients (40 in each group) scheduled for elective posterior chamber surgery using&#xD;
      peribulbar block. Patients of Group N received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase&#xD;
      (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group F&#xD;
      received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20&#xD;
      μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml&#xD;
      hyaluronidase (75 IU) and1 ml saline (total 8 ml).&#xD;
&#xD;
      Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe&#xD;
      akinesia, total 15-min akinesia score and duration of block.&#xD;
&#xD;
      Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure&#xD;
      and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was&#xD;
      hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of &gt;5.&#xD;
&#xD;
      Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood&#xD;
      pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops&#xD;
      0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam&#xD;
      (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal&#xD;
      oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for&#xD;
      each group was injected in the medial canthus (the tunnel between the caruncle and the medial&#xD;
      canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle&#xD;
      and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction&#xD;
      of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5&#xD;
      ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle&#xD;
      directed downward and medially below the globe. Light orbital compression applied for 1&#xD;
      minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and&#xD;
      chemosis.&#xD;
&#xD;
      All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP,&#xD;
      DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">May 18, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patients were grouped randomly using sealed envelopes prepared by an assistant who was blinded to the grouping and envelops were chosen by patient him/her self or by the nearest relative All patients received 8 ml of LAM which consisted of: 3 ml of mepivacaine 3%,&#xD;
1 ml of hyaluronidase containing 150 IU, 2 ml of bupivacaine 0.5%, 1 ml of lidocaine 2%.Patients were categorized into three groups according to the type of additive used with the LAM as follows:&#xD;
Group C (Control group): included patients assigned to receive 1 ml normal saline.&#xD;
Group F: 1 ml saline containing 20 μg fentanyl was used instead of normal saline.&#xD;
Group N:1 ml saline containing 4mg nalbuphine was used instead of normal saline.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Onset of eyelid and globe akinesia</measure>
    <time_frame>24 hours Postoperative</time_frame>
    <description>The onset of eyelid and globe akinesia was assessed till complete recovery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>24 hours Postoperative</time_frame>
    <description>Blood pressure (mmHg) .Hypotension is defined as a 20% decrease in MAP in relation to baseline measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>24 hours Postoperative</time_frame>
    <description>Heart rate (beat/minute).Bradycardia were defined as a 20% decrease in HR in relation to baseline measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Operative analgesia</measure>
    <time_frame>24 hours Postoperative</time_frame>
    <description>Assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates sever pain sensation. PO analgesia was provided as if VAS was &gt;5 in the form of I.M injection of pethidine50 mg</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Nalbuphine,Fentanyl and Local Anesthetic Mixture</condition>
  <arm_group>
    <arm_group_label>Nalbuphine Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine Group</intervention_name>
    <description>All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive&#xD;
Patients were categorized into three groups according to the type of additive used with the LAM as follows:&#xD;
Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline</description>
    <arm_group_label>Nalbuphine Group</arm_group_label>
    <other_name>Group N</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl Group</intervention_name>
    <description>All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive&#xD;
Patients were categorized into three groups according to the type of additive used with the LAM as follows:&#xD;
Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline</description>
    <arm_group_label>Fentanyl Group</arm_group_label>
    <other_name>Group F</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive&#xD;
Patients were categorized into three groups according to the type of additive used with the LAM as follows:&#xD;
Group C (Control group): included patients assigned to receive 1 ml normal saline.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Group C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 40-70 years.&#xD;
&#xD;
          -  both sex.&#xD;
&#xD;
          -  ASA physical status Ι&amp;II.&#xD;
&#xD;
          -  Patient with axial globe length below 26&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to participate in the study.&#xD;
&#xD;
          -  Coagulation abnormalities(INR&gt;1.4).&#xD;
&#xD;
          -  More than ASA II.&#xD;
&#xD;
          -  High myopia with axial length more than 26 mm.&#xD;
&#xD;
          -  Mentally retarded patients and failure of proper communication as in deafness .&#xD;
&#xD;
          -  Morbidly obese patients(BMI&gt;35)&#xD;
&#xD;
          -  Patients with glaucoma (increased IOP&gt;20mmgh)&#xD;
&#xD;
          -  Patients with history of hypersensitivity to study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Abdalla Mohamed, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Abdalla Mohamed</name>
      <address>
        <city>Cairo</city>
        <zip>11451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdalla</investigator_full_name>
    <investigator_title>Professor of Anesthesia &amp;I.C.U and Pain Clinic, Cairo University</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Till Press</ipd_description>
  </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/NCT03824665
org study id: Nalbuphine Versus Fentanyl
nct id: NCT03824665
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal
      anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration
      of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg
      Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block
      undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl
      20 μg to LAM and LAM alone
120 patients (40 in each group) scheduled for elective posterior chamber surgery using
      peribulbar block. Patients of Group N received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase
      (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group F
      received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20
      μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml
      hyaluronidase (75 IU) and1 ml saline (total 8 ml).

      Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe
      akinesia, total 15-min akinesia score and duration of block.

      Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure
      and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was
      hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.

      Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood
      pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops
      0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam
      (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal
      oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for
      each group was injected in the medial canthus (the tunnel between the caruncle and the medial
      canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle
      and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction
      of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5
      ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle
      directed downward and medially below the globe. Light orbital compression applied for 1
      minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and
      chemosis.

      All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP,
      DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: Patients were grouped randomly using sealed envelopes prepared by an assistant who was blinded to the grouping and envelops were chosen by patient him/her self or by the nearest relative All patients received 8 ml of LAM which consisted of: 3 ml of mepivacaine 3%,
1 ml of hyaluronidase containing 150 IU, 2 ml of bupivacaine 0.5%, 1 ml of lidocaine 2%.Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group C (Control group): included patients assigned to receive 1 ml normal saline.
Group F: 1 ml saline containing 20 μg fentanyl was used instead of normal saline.
Group N:1 ml saline containing 4mg nalbuphine was used instead of normal saline.
measure: Onset of eyelid and globe akinesia
time frame: 24 hours Postoperative
description: The onset of eyelid and globe akinesia was assessed till complete recovery
measure: Blood pressure
time frame: 24 hours Postoperative
description: Blood pressure (mmHg) .Hypotension is defined as a 20% decrease in MAP in relation to baseline measures
measure: Heart rate
time frame: 24 hours Postoperative
description: Heart rate (beat/minute).Bradycardia were defined as a 20% decrease in HR in relation to baseline measures
measure: Post Operative analgesia
time frame: 24 hours Postoperative
description: Assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates sever pain sensation. PO analgesia was provided as if VAS was >5 in the form of I.M injection of pethidine50 mg
arm group label: Nalbuphine Group
arm group type: Active Comparator
description: Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine
arm group label: Fentanyl Group
arm group type: Active Comparator
description: Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl
arm group label: Control group
arm group type: Active Comparator
description: Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline
intervention type: Drug
intervention name: Nalbuphine Group
description: All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline
arm group label: Nalbuphine Group
other name: Group N
intervention type: Drug
intervention name: Fentanyl Group
description: All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline
arm group label: Fentanyl Group
other name: Group F
intervention type: Drug
intervention name: Control Group
description: All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group C (Control group): included patients assigned to receive 1 ml normal saline.
arm group label: Control group
other name: Group C
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Abdalla Mohamed, M.D
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdalla
investigator title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
mesh term: Fentanyl
mesh term: Nalbuphine
sharing ipd: Undecided
ipd description: Till Press