<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/NCT03241875</url>
  </required_header>
  <id_info>
    <org_study_id>Nakhli anesthesia sahloul</org_study_id>
    <nct_id>NCT03241875</nct_id>
  </id_info>
  <brief_title>Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy</brief_title>
  <official_title>Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculty of Medicine, Sousse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculty of Medicine, Sousse</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of premedication with pregabalin or&#xD;
      gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to&#xD;
      surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and&#xD;
      vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in&#xD;
      the intensity of postoperative pain after laparoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative shoulder pain</measure>
    <time_frame>VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery</time_frame>
    <description>Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>remifentanil consumption during anesthesia</measure>
    <time_frame>one hour after tracheal tube removal</time_frame>
    <description>Remifentanil requirements during anesthesia were calculated (µg/kg/mn)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative sleep quality during the first night</measure>
    <time_frame>first night after surgery</time_frame>
    <description>Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative nausea and vomiting</measure>
    <time_frame>2, 6, 12, 24 and 48 hours after surgery.</time_frame>
    <description>The intensity of post operative nausea and vomiting was assessed by a 0 to 3 score (0: no nausea or vomiting, 1: slight mild nausea, 2: moderate nausea, 3: vomiting).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Cholecystectomy, Laparoscopic</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin 75mg</intervention_name>
    <description>In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.</description>
    <arm_group_label>pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin 300mg</intervention_name>
    <description>In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.</description>
    <arm_group_label>gabapentin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uncomplicated laparoscopic cholecystectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) status &lt; 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute cholecystitis&#xD;
&#xD;
          -  conversion to open cholecystectomy&#xD;
&#xD;
          -  history of epilepsia, psychiatric disorders and cognitive impairment&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#xD;
&#xD;
          -  allergy to pregabalin and/or gabapentin&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory&#xD;
             drugs&#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>Mohamed Said Nakhli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Sousse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahloul Teaching Hospital</name>
      <address>
        <city>Sousse</city>
        <zip>4054</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <results_reference>
    <citation>Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.</citation>
    <PMID>17513656</PMID>
  </results_reference>
  <results_reference>
    <citation>Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.</citation>
    <PMID>26705527</PMID>
  </results_reference>
  <results_reference>
    <citation>Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.</citation>
    <PMID>18716003</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculty of Medicine, Sousse</investigator_affiliation>
    <investigator_full_name>Mohamed Said NAKHLI</investigator_full_name>
    <investigator_title>MD, anesthesia and intensive care</investigator_title>
  </responsible_party>
  <keyword>pregabalin</keyword>
  <keyword>gabapentin</keyword>
  <keyword>post operative pain</keyword>
  <keyword>laparoscopic cholecystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03241875
org study id: Nakhli anesthesia sahloul
nct id: NCT03241875
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to evaluate the effect of premedication with pregabalin or
      gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.
Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to
      surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and
      vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in
      the intensity of postoperative pain after laparoscopic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Post operative shoulder pain
time frame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
description: Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).
measure: remifentanil consumption during anesthesia
time frame: one hour after tracheal tube removal
description: Remifentanil requirements during anesthesia were calculated (µg/kg/mn)
measure: Post operative sleep quality during the first night
time frame: first night after surgery
description: Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.
measure: Post operative nausea and vomiting
time frame: 2, 6, 12, 24 and 48 hours after surgery.
description: The intensity of post operative nausea and vomiting was assessed by a 0 to 3 score (0: no nausea or vomiting, 1: slight mild nausea, 2: moderate nausea, 3: vomiting).
arm group label: placebo
arm group type: Placebo Comparator
description: Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.
arm group label: pregabalin
arm group type: Experimental
description: patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.
arm group label: gabapentin
arm group type: Experimental
description: patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.
intervention type: Drug
intervention name: Pregabalin 75mg
description: In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
arm group label: pregabalin
intervention type: Drug
intervention name: Gabapentin 300mg
description: In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
arm group label: gabapentin
intervention type: Drug
intervention name: Placebo oral capsule
description: In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
arm group label: placebo
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mohamed Said Nakhli, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Sousse
facility: 
country: Tunisia
citation: Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
PMID: 17513656
citation: Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.
PMID: 26705527
citation: Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
PMID: 18716003
responsible party type: Principal Investigator
investigator affiliation: Faculty of Medicine, Sousse
investigator full name: Mohamed Said NAKHLI
investigator title: MD, anesthesia and intensive care
mesh term: Shoulder Pain
mesh term: Pain, Postoperative
mesh term: Pregabalin
mesh term: Gabapentin
sharing ipd: Undecided