<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/NCT03243032</url>
  </required_header>
  <id_info>
    <org_study_id>201707814</org_study_id>
    <nct_id>NCT03243032</nct_id>
  </id_info>
  <brief_title>Pre-Emptive Analgesia in Dental Implant Surgery</brief_title>
  <official_title>Pain Management Using Pre-Emptive Analgesia in Dental Implant Surgery - A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Satheesh Elangovan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      To determine the clinical effectiveness of combined use of pre-emptive analgesia and long&#xD;
      acting anesthesia for pain suppression following dental implant surgery as measured by a&#xD;
      validated numerical rating scale and the information related to consumption of post-operative&#xD;
      medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental practitioners often prescribe opioids for the relief of moderate - severe acute&#xD;
      post-operative pain.1 There is evidence that alternative approaches, such as the use of long&#xD;
      acting local anesthetics along with the combination of non-opioid analgesics such as&#xD;
      acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), may prevent the need for&#xD;
      opioid medications. With the current national opioid overdose epidemic, government officials&#xD;
      have introduced new prescribing recommendations for the management of acute pain. Dentists&#xD;
      can play a role to address this epidemic by wider recognition and adoption of the new&#xD;
      prescribing recommendations for fast acting pre-emptive non-opioid analgesics to prevent&#xD;
      acute dental pain.2 Dentists are the fifth leading prescribers of opioids among health care&#xD;
      professionals accounting for 12% of the total immediate-release opioids prescribed in the&#xD;
      United States (U.S).3 With the increasing trends of opioid prescribing for dental surgeries&#xD;
      in the past few decades, dental implant procedures hold the highest increasing rate for&#xD;
      opioid prescribing.4 In the U.S alone, there has been as many as 183,000 prescription opioid&#xD;
      overdose related deaths from 1999 to 2015. Since 1999, the mortality rate from opioid&#xD;
      overdose has more than quadrupled.5 With more than 650,000 opioid prescriptions being&#xD;
      dispensed daily in the U.S,6 there has been a national call to alter the current prescribing&#xD;
      patterns of opioids to ensure appropriate indications and patient selection.7 There are&#xD;
      multiple adverse effects that may develop from opioid pain medications: nausea, vomiting,&#xD;
      constipation, dizziness, headache.8 However, two major concerns associated with the excessive&#xD;
      prescribing of opioids are overdosing leading to life threatening respiratory depression&#xD;
      problems and the creation of an environment that fosters the development of opioid&#xD;
      dependency, abuse and addiction.8 The U.S. Senate passed the 'Comprehensive Addiction and&#xD;
      Recovery Act' of 2016 to combat the opioid epidemic.9 This legislation is designed to prevent&#xD;
      opioid-related morbidity and misuse via physician and patient education, risk awareness,&#xD;
      proper prescribing practices, and efforts to improve safer handling of prescription opioids.9&#xD;
      NSAIDs are widely used for their anti-inflammatory, pain and fever reducing properties. In&#xD;
      the periphery, these drugs interfere with the formation of pro-inflammatory modulating&#xD;
      prostaglandins and thromboxane A2 via reversible inhibition of the cyclooxygenase enzymes&#xD;
      (Cox-1 and Cox-2). NSAIDs exact their effects through a variety of peripheral and central&#xD;
      mechanisms. Their efficacy in the reduction of post-operative pain has been widely&#xD;
      documented.10 It has been demonstrated that a single dose of an NSAID (i.e. etoricoxib,&#xD;
      ketoprofen, diclofenac potassium, diflunisan, ibuprofen) may provide better acute&#xD;
      post-operative analgesia than some commonly prescribed single dose opioids, even when they&#xD;
      are prescribed in combination with other NSAIDs.10 There is also sound evidence that some&#xD;
      individuals receive synergistic analgesic effects when NSAIDs are combined with&#xD;
      acetaminophen.11 However, these effects can vary, as not everyone will achieve adequate pain&#xD;
      relief even from the most potent drugs. Simple drug combinations of fast acting&#xD;
      anti-inflammatories with acetaminophen can reliably provide successful analgesia for many&#xD;
      acute pain patients in reasonably low doses.10 While modern dental literature contains&#xD;
      numerous articles that support the tolerability, safety and efficacy of NSAIDs, many dental&#xD;
      practices continue to prescribe opioids in cases which would likely respond better to other&#xD;
      analgesics. Many dentists still underrate the risks and abuse of opioids. That is why it is&#xD;
      important to design and test more lucid protocols for prescribing analgesics in dental care&#xD;
      settings.&#xD;
&#xD;
      Severity of post-operative pain in periodontal and dental implant surgery can vary between&#xD;
      mild to severe 12,13 and patient-reported outcome measures (PROMs) can be adverse at times.14&#xD;
      There is evidence that straightforward implant placement procedure is a surgical procedure&#xD;
      associated with relatively low postoperative pain and pain management following dental&#xD;
      implants is usually achieved by the use of drugs such as NSAIDs, acetaminophen, and/or&#xD;
      opioids.11,15 Pre-emptive analgesia refers to the reduction of pain severity that occurs&#xD;
      post-operatively by suppressing pain pre-emptively prior to the performance of the surgical&#xD;
      procedure.16,17 Previous studies have shown the rationale and efficacy of using pre-emptive&#xD;
      analgesia in periodontal and oral surgical models.18-25 Long acting local anesthetics such as&#xD;
      bupivacaine have been shown to prolong the onset of and suppress postoperative pain better&#xD;
      than lidocaine, an intermediate duration anesthetic.26,27 With successful pre-emptive&#xD;
      analgesia including NSAIDs and long acting local anesthetics, the need for stronger&#xD;
      post-operative analgesics, like opioids, may be significantly decreased.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB requirements to start study could not be met in a timely manner&#xD;
  </why_stopped>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">November 6, 2017</completion_date>
  <primary_completion_date type="Actual">November 6, 2017</primary_completion_date>
  <phase>Early Phase 1</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>Randomized, parallel arms, double-blinded, placebo-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will not know which arm they will be in initially. At the 2 week post-operative visit they may be notified of which arm they participated in if they so choose to find out.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain as measured by numerical rating scale</measure>
    <time_frame>24 hours</time_frame>
    <description>Difference in pain scores between test and control groups during the time points assessed (0 min, 30, 60, 90, 120, 150, 180, 210, 240 minutes and 24 hours) will be analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total pain medication consumption between test and control</measure>
    <time_frame>14 days</time_frame>
    <description>Difference in pain medication consumption between test and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time duration to take first pain medication between test and control</measure>
    <time_frame>14 days</time_frame>
    <description>Difference in the time duration to take the first post-operative pain medication between test and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain with anterior versus posterior site of surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Within the control and test groups, correlation between sites (anterior versus posterior) and post-operative pain levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain as it correlates with the duration of the surgical procedure</measure>
    <time_frame>24 hours</time_frame>
    <description>The duration of each surgical procedure will be recorded and separate correlation analyses will be performed to assess the correlation between procedural duration and post-operative pain, within each arm of the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-surgical anxiety correlated with post-surgical pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Association between pre-surgical anxiety level and post-surgical pain level as measured by the pain scale within the control group, within the test group and together.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications following surgery</measure>
    <time_frame>14 days</time_frame>
    <description>Any complications encountered from medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Local Anesthetic Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 (Pre-emptive analgesia with long acting local anesthesia - experimental group): Ibuprofen 600mg given 30 minutes prior to beginning of surgery. Surgery will be performed only using 0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg four times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local Anesthetic Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group 2 (Control / standard of care group): Placebo oral capsule (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery. Surgery will be performed using 2% lidocaine with 1:100,000 epinephrine as the local anesthesia. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg 4 times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen 600 mg</intervention_name>
    <description>Ibuprofen 600mg given 30 minutes prior to beginning of surgery</description>
    <arm_group_label>Local Anesthetic Group 1</arm_group_label>
    <other_name>non-steroidal anti-inflammatory (NSAID)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local anesthetic Group 1</intervention_name>
    <description>0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic for Group 1 Experimental.</description>
    <arm_group_label>Local Anesthetic Group 1</arm_group_label>
    <other_name>anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery</description>
    <arm_group_label>Local Anesthetic Control</arm_group_label>
    <other_name>Placebo - Microcrystalline Cellulose NF (Avicel PH 105)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local anesthetic Control</intervention_name>
    <description>2% lidocaine with 1:100,000 epinephrine as the local anesthetic for Group 2 - Control</description>
    <arm_group_label>Local Anesthetic Control</arm_group_label>
    <other_name>anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients 18 years of age and under 65 years of age&#xD;
&#xD;
          -  ASA Type I &amp; II&#xD;
&#xD;
          -  Single tooth edentulous site requiring dental implant placement without any additional&#xD;
             bone or soft tissue augmentation at the time of implant placement&#xD;
&#xD;
          -  Patients not requiring use of any form of sedation for dental implant surgery&#xD;
             (nitrous, oral or IV sedation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to NSAIDs, salicylates, or microcrystalline cellulose NF (Avicel PH&#xD;
             105)&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Hypertension and taking angiotensin-converting-enzyme inhibitors and/or diuretics&#xD;
&#xD;
          -  Significant respiratory conditions including acute or severe asthma.&#xD;
&#xD;
          -  Cardiovascular disease that will prevent the patient from going through the surgical&#xD;
             procedure or consuming the required medications: cardiac disease, cardiomyopathy,&#xD;
             cardiac arrhythmias, coronary heart disease, acute MI, angina, history of MI, coronary&#xD;
             artery bypass grafting (CABG), Aspirin intake, peripheral vascular disease, cerebral&#xD;
             vascular disease (stroke, TIA)&#xD;
&#xD;
          -  Gastrointestinal disease including irritable bowel disease and gastric ulcers&#xD;
&#xD;
          -  Hematological diseases (coagulopathy, hemophilia or thrombocytopenia)&#xD;
&#xD;
          -  Pregnancy/lactation at the time of surgery&#xD;
&#xD;
          -  Heavy smoking (&gt;10 cigarettes per day)&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Allergies or intolerance to ibuprofen, opioids, and local anesthetic (lidocaine and&#xD;
             bupivacaine)&#xD;
&#xD;
          -  History of recreational drug abuse&#xD;
&#xD;
          -  History of heavy alcohol use. Substance Abuse and Mental Health Services&#xD;
             Administration (SAMSHA)30 defines heavy alcohol use as binge drinking on 5 or more&#xD;
             days in the past month. SAMSHA defines binge drinking as 5 or more alcoholic drinks&#xD;
             for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the&#xD;
             same time or within a couple of hours of each other) on at least 1 day in the past&#xD;
             month.&#xD;
&#xD;
          -  Patients currently taking prescription pain medications or have taken over-the-counter&#xD;
             pain medications within 4 days of surgery.&#xD;
&#xD;
          -  Patients with drug-drug or drug-disease state interactions&#xD;
&#xD;
          -  Other significant medical conditions (not reported above) that are likely to prevent&#xD;
             the patient from going through the surgical procedure or consuming the required&#xD;
             medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sathesh Elangovan, BDS</last_name>
    <role>Study Director</role>
    <affiliation>University of Iowa College of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univerity of Iowa College of Dentsitry Dental Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Satheesh Elangovan</investigator_full_name>
    <investigator_title>Principal Investigator</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>Ibuprofen</mesh_term>
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</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/NCT03243032
org study id: 201707814
nct id: NCT03243032
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To determine the clinical effectiveness of combined use of pre-emptive analgesia and long
      acting anesthesia for pain suppression following dental implant surgery as measured by a
      validated numerical rating scale and the information related to consumption of post-operative
      medications.
Dental practitioners often prescribe opioids for the relief of moderate - severe acute
      post-operative pain.1 There is evidence that alternative approaches, such as the use of long
      acting local anesthetics along with the combination of non-opioid analgesics such as
      acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), may prevent the need for
      opioid medications. With the current national opioid overdose epidemic, government officials
      have introduced new prescribing recommendations for the management of acute pain. Dentists
      can play a role to address this epidemic by wider recognition and adoption of the new
      prescribing recommendations for fast acting pre-emptive non-opioid analgesics to prevent
      acute dental pain.2 Dentists are the fifth leading prescribers of opioids among health care
      professionals accounting for 12% of the total immediate-release opioids prescribed in the
      United States (U.S).3 With the increasing trends of opioid prescribing for dental surgeries
      in the past few decades, dental implant procedures hold the highest increasing rate for
      opioid prescribing.4 In the U.S alone, there has been as many as 183,000 prescription opioid
      overdose related deaths from 1999 to 2015. Since 1999, the mortality rate from opioid
      overdose has more than quadrupled.5 With more than 650,000 opioid prescriptions being
      dispensed daily in the U.S,6 there has been a national call to alter the current prescribing
      patterns of opioids to ensure appropriate indications and patient selection.7 There are
      multiple adverse effects that may develop from opioid pain medications: nausea, vomiting,
      constipation, dizziness, headache.8 However, two major concerns associated with the excessive
      prescribing of opioids are overdosing leading to life threatening respiratory depression
      problems and the creation of an environment that fosters the development of opioid
      dependency, abuse and addiction.8 The U.S. Senate passed the 'Comprehensive Addiction and
      Recovery Act' of 2016 to combat the opioid epidemic.9 This legislation is designed to prevent
      opioid-related morbidity and misuse via physician and patient education, risk awareness,
      proper prescribing practices, and efforts to improve safer handling of prescription opioids.9
      NSAIDs are widely used for their anti-inflammatory, pain and fever reducing properties. In
      the periphery, these drugs interfere with the formation of pro-inflammatory modulating
      prostaglandins and thromboxane A2 via reversible inhibition of the cyclooxygenase enzymes
      (Cox-1 and Cox-2). NSAIDs exact their effects through a variety of peripheral and central
      mechanisms. Their efficacy in the reduction of post-operative pain has been widely
      documented.10 It has been demonstrated that a single dose of an NSAID (i.e. etoricoxib,
      ketoprofen, diclofenac potassium, diflunisan, ibuprofen) may provide better acute
      post-operative analgesia than some commonly prescribed single dose opioids, even when they
      are prescribed in combination with other NSAIDs.10 There is also sound evidence that some
      individuals receive synergistic analgesic effects when NSAIDs are combined with
      acetaminophen.11 However, these effects can vary, as not everyone will achieve adequate pain
      relief even from the most potent drugs. Simple drug combinations of fast acting
      anti-inflammatories with acetaminophen can reliably provide successful analgesia for many
      acute pain patients in reasonably low doses.10 While modern dental literature contains
      numerous articles that support the tolerability, safety and efficacy of NSAIDs, many dental
      practices continue to prescribe opioids in cases which would likely respond better to other
      analgesics. Many dentists still underrate the risks and abuse of opioids. That is why it is
      important to design and test more lucid protocols for prescribing analgesics in dental care
      settings.

      Severity of post-operative pain in periodontal and dental implant surgery can vary between
      mild to severe 12,13 and patient-reported outcome measures (PROMs) can be adverse at times.14
      There is evidence that straightforward implant placement procedure is a surgical procedure
      associated with relatively low postoperative pain and pain management following dental
      implants is usually achieved by the use of drugs such as NSAIDs, acetaminophen, and/or
      opioids.11,15 Pre-emptive analgesia refers to the reduction of pain severity that occurs
      post-operatively by suppressing pain pre-emptively prior to the performance of the surgical
      procedure.16,17 Previous studies have shown the rationale and efficacy of using pre-emptive
      analgesia in periodontal and oral surgical models.18-25 Long acting local anesthetics such as
      bupivacaine have been shown to prolong the onset of and suppress postoperative pain better
      than lidocaine, an intermediate duration anesthetic.26,27 With successful pre-emptive
      analgesia including NSAIDs and long acting local anesthetics, the need for stronger
      post-operative analgesics, like opioids, may be significantly decreased.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, parallel arms, double-blinded, placebo-controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will not know which arm they will be in initially. At the 2 week post-operative visit they may be notified of which arm they participated in if they so choose to find out.
measure: Post-operative pain as measured by numerical rating scale
time frame: 24 hours
description: Difference in pain scores between test and control groups during the time points assessed (0 min, 30, 60, 90, 120, 150, 180, 210, 240 minutes and 24 hours) will be analyzed.
measure: Total pain medication consumption between test and control
time frame: 14 days
description: Difference in pain medication consumption between test and control groups
measure: Time duration to take first pain medication between test and control
time frame: 14 days
description: Difference in the time duration to take the first post-operative pain medication between test and control groups
measure: Post-operative pain with anterior versus posterior site of surgery
time frame: 24 hours
description: Within the control and test groups, correlation between sites (anterior versus posterior) and post-operative pain levels
measure: Post-operative pain as it correlates with the duration of the surgical procedure
time frame: 24 hours
description: The duration of each surgical procedure will be recorded and separate correlation analyses will be performed to assess the correlation between procedural duration and post-operative pain, within each arm of the trial.
measure: Pre-surgical anxiety correlated with post-surgical pain
time frame: 24 hours
description: Association between pre-surgical anxiety level and post-surgical pain level as measured by the pain scale within the control group, within the test group and together.
measure: Complications following surgery
time frame: 14 days
description: Any complications encountered from medications
arm group label: Local Anesthetic Group 1
arm group type: Experimental
description: Group 1 (Pre-emptive analgesia with long acting local anesthesia - experimental group): Ibuprofen 600mg given 30 minutes prior to beginning of surgery. Surgery will be performed only using 0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg four times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.
arm group label: Local Anesthetic Control
arm group type: Placebo Comparator
description: Group 2 (Control / standard of care group): Placebo oral capsule (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery. Surgery will be performed using 2% lidocaine with 1:100,000 epinephrine as the local anesthesia. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg 4 times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.
intervention type: Drug
intervention name: Ibuprofen 600 mg
description: Ibuprofen 600mg given 30 minutes prior to beginning of surgery
arm group label: Local Anesthetic Group 1
other name: non-steroidal anti-inflammatory (NSAID)
intervention type: Drug
intervention name: Local anesthetic Group 1
description: 0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic for Group 1 Experimental.
arm group label: Local Anesthetic Group 1
other name: anesthesia
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery
arm group label: Local Anesthetic Control
other name: Placebo - Microcrystalline Cellulose NF (Avicel PH 105)
intervention type: Drug
intervention name: Local anesthetic Control
description: 2% lidocaine with 1:100,000 epinephrine as the local anesthetic for Group 2 - Control
arm group label: Local Anesthetic Control
other name: anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sathesh Elangovan, BDS
role: Study Director
affiliation: University of Iowa College of Dentistry
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Satheesh Elangovan
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Ibuprofen
mesh term: Anti-Inflammatory Agents
mesh term: Anesthetics
mesh term: Anesthetics, Local
sharing ipd: No