<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/NCT03013361</url>
  </required_header>
  <id_info>
    <org_study_id>9157/PG2Trg/2012/15727</org_study_id>
    <nct_id>NCT03013361</nct_id>
  </id_info>
  <brief_title>Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery</brief_title>
  <official_title>Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or&#xD;
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)&#xD;
      block, infraorbital nerve block and nasociliary block. As the current evidences regarding the&#xD;
      benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block&#xD;
      will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients&#xD;
      undergoing FESS under general anaesthesia in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the&#xD;
      treatment of sinonasal disease. Although it is a minimally invasive and less traumatic&#xD;
      procedure, it is usually associated with pain of mild to moderate intensity which reaches its&#xD;
      maximum level in the first few postoperative hours. However, even low-level postoperative&#xD;
      pain may be associated with delayed functional recovery and it frequently contributes to&#xD;
      dissatisfaction with the procedure delay in return to work and readmission after surgery.&#xD;
      Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or&#xD;
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)&#xD;
      block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG&#xD;
      supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide&#xD;
      perioperative analgesia after FESS. Integration of regional anaesthesia with general&#xD;
      anaesthesia technique can provide a better hemodynamic control, less perioperative opioid&#xD;
      use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding&#xD;
      in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use&#xD;
      may be translated into a less postoperative nausea &amp; vomiting, rapid recovery and early&#xD;
      hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS&#xD;
      is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion&#xD;
      block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult&#xD;
      patients undergoing FESS under general anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 3</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery</measure>
    <time_frame>30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first administration of rescue analgesia was recorded.</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Functional Endoscopic Sinus Surgery (FESS)</condition>
  <arm_group>
    <arm_group_label>Group B (n=20)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group R (n=20):</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group S (n=20, Control):</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Post operative pain control</description>
    <arm_group_label>Group B (n=20)</arm_group_label>
    <other_name>Anawin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Post operative pain control</description>
    <arm_group_label>Group R (n=20):</arm_group_label>
    <other_name>Ropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Acts as comparator</description>
    <arm_group_label>Group S (n=20, Control):</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 American Society of Anesthesiologists (ASA) physical status I and II patients&#xD;
&#xD;
          -  aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for&#xD;
             sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were&#xD;
             enrolled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or&#xD;
             coagulopathy&#xD;
&#xD;
          -  History of allergy to any of the medications being used in the study&#xD;
&#xD;
          -  Previous surgery for sinonasal disease&#xD;
&#xD;
          -  Pre-existing chronic pain not related to chronic rhinosinusitis&#xD;
&#xD;
          -  Taking prescription pain medications or antidepressants&#xD;
&#xD;
          -  Chronic alcohol or drug abuse&#xD;
&#xD;
          -  Inability to comprehend the study protocol&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameer Sethi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMER, Chandigarh,India</affiliation>
  </overall_official>
  <results_reference>
    <citation>1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.</citation>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr Sameer Sethi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ropivacaine, bupivacaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganglion Cysts</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</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/NCT03013361
org study id: 9157/PG2Trg/2012/15727
nct id: NCT03013361
lead sponsor: 
has dmc: Yes
Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)
      block, infraorbital nerve block and nasociliary block. As the current evidences regarding the
      benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block
      will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients
      undergoing FESS under general anaesthesia in this study.
Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the
      treatment of sinonasal disease. Although it is a minimally invasive and less traumatic
      procedure, it is usually associated with pain of mild to moderate intensity which reaches its
      maximum level in the first few postoperative hours. However, even low-level postoperative
      pain may be associated with delayed functional recovery and it frequently contributes to
      dissatisfaction with the procedure delay in return to work and readmission after surgery.
      Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)
      block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG
      supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide
      perioperative analgesia after FESS. Integration of regional anaesthesia with general
      anaesthesia technique can provide a better hemodynamic control, less perioperative opioid
      use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding
      in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use
      may be translated into a less postoperative nausea & vomiting, rapid recovery and early
      hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS
      is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion
      block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult
      patients undergoing FESS under general anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery
time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.
measure: Time to first administration of rescue analgesia was recorded.
time frame: 8 hours
measure: Patient satisfaction score
time frame: 8 hours
arm group label: Group B (n=20)
arm group type: Active Comparator
description: Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.
arm group label: Group R (n=20):
arm group type: Active Comparator
description: Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.
arm group label: Group S (n=20, Control):
arm group type: Placebo Comparator
description: Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.
intervention type: Drug
intervention name: Bupivacaine
description: Post operative pain control
arm group label: Group B (n=20)
other name: Anawin
intervention type: Drug
intervention name: Ropivacaine
description: Post operative pain control
arm group label: Group R (n=20):
other name: Ropin
intervention type: Other
intervention name: Normal Saline
description: Acts as comparator
arm group label: Group S (n=20, Control):
other name: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sameer Sethi, MD
role: Principal Investigator
affiliation: PGIMER, Chandigarh,India
citation: 1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr Sameer Sethi
investigator title: Principal Investigator
mesh term: Ganglion Cysts
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: No