<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/NCT04459026</url>
  </required_header>
  <id_info>
    <org_study_id>ropivacaine</org_study_id>
    <nct_id>NCT04459026</nct_id>
  </id_info>
  <brief_title>Comparison of Administation Routes of Ropivacaine</brief_title>
  <official_title>Comparative Study Between Different Routes of Ropivacaïne Administration to Reduce Post-operative Pain in Gynecological Laparoscopy, a Double Blind Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiteit Antwerpen</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of different routes of local anaesthesia&#xD;
      administration in laparoscopic procedures to reduce post-operative pain (intra-peritoneal&#xD;
      infusion of Ropivacaine 0.75%, port site injection of Ropivacaine 0.75% or a combination of&#xD;
      both techniques), through a randomized one-center double-blinded study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Question What is the best route of Ropivacaine administration in laparoscopic&#xD;
      procedures in decreasing post-operative pain? Is it port site injection, intra-peritoneal&#xD;
      instillation of local anesthetics or is it a combination of both routes? Our hypothesis is&#xD;
      that a combination of port site injection and intra-peritoneal instillation of local&#xD;
      anesthetics will be more effective in lowering pain the first 24 hours after surgery.&#xD;
&#xD;
      3. Characteristics of the patient population Inclusion criteria&#xD;
&#xD;
        1. Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.&#xD;
&#xD;
        2. Successful laparoscopy without surgical or anesthetic complications.&#xD;
&#xD;
        3. Female&#xD;
&#xD;
        4. 18-70 years&#xD;
&#xD;
        5. ASA( American Society of Anesthesia) I-II Exclusion criteria&#xD;
&#xD;
      (1) Hypersensitivity to anaesthetics of the amide-type (2) Obesity, BMI &gt; 35 (3) Patients&#xD;
      with chronic use of analgesics / chronic pain (4) Patients with an abnormal liver function&#xD;
      (5) Urgent surgical procedures (6) Pregnancy (this means we only include patients who use&#xD;
      contraceptives, are sterilized, have a negative dipstick testing or a negative serum testing&#xD;
      or patients who are postmenopausal) 4. Characteristics of the treatment We will be using&#xD;
      ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose&#xD;
      of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the&#xD;
      patient belongs to, this dose will be given in full by either local injection at the trocar&#xD;
      entry points or by intraperitoneal injection or it will be divided between both injection&#xD;
      sites, respectively 1mg at the trocar sites and 2mg intraperitoneal. The unequal dose&#xD;
      distribution is based on the surface area the local anaesthetic has to cover.&#xD;
&#xD;
      5. Methodology Anaesthetic management will be standardized for each person. The anaesthetist&#xD;
      will insert an intravenous line and connect the patient to the monitor. We will be using&#xD;
      routine intraoperative monitoring devices such as an electrocardiograph, a pulse oximetry and&#xD;
      a non-invasive blood pressure monitor. The patient is preoxygenated with 100% O2 before&#xD;
      induction.&#xD;
&#xD;
      Anaesthetic protocol&#xD;
&#xD;
      Induction:&#xD;
&#xD;
        -  fentanyl 2μg/kg&#xD;
&#xD;
        -  Propofol TCI marsh model 6μg/ml - titration based on effect&#xD;
&#xD;
        -  Rocuronium 0.5mg/kg&#xD;
&#xD;
      Maintenance:&#xD;
&#xD;
      - Propofol TCI Marsh model: 4μ/ml - (8-12mg/kg/u) - titration based on effect, blood pressure&#xD;
      and heart rate.&#xD;
&#xD;
      Analgesia intraoperatively:&#xD;
&#xD;
        -  Ketorolac 30mg at induction (if no contraindications; and &gt; 60kg; if the patient weight&#xD;
           is &lt; 60kg the dose will be lowered to 20mg)&#xD;
&#xD;
        -  Paracetamol 1g one half hour before the end of the surgery Different study groups&#xD;
&#xD;
      At the end of the successful gynaecologic laparoscopy, patients will receive the additional&#xD;
      pain management according to their randomly assigned study group:&#xD;
&#xD;
        -  Group A patients will receive 1) intra-abdominal instillation 0.75% Ropivacaine 2 mg /&#xD;
           kg in 200 ml of NaCl through the trocars and 2) Infiltration of the surgical wounds at&#xD;
           the trocar sites with 0.75% Ropivacaine 1 mg / kg in 20 ml of NaCl (Sodiumchloride)&#xD;
&#xD;
        -  Group B patients will receive infiltration of the surgical wounds at the trocar sites&#xD;
           with 0.75% Ropivacaine 3 mg / kg in 20 ml of NaCl.&#xD;
&#xD;
        -  Group C patients will receive intra-abdominal instillation 0.75% Ropivacaine 3 mg / kg&#xD;
           in 200 ml of NaCl through the trocars.&#xD;
&#xD;
      Suction and aspiration is avoided after instillation of local anaesthetic intra-abdominal in&#xD;
      group A and C.&#xD;
&#xD;
      The study medication will be prepared in the operating room right before use. This means that&#xD;
      neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. This&#xD;
      isn't a problem since it is already at the end of the procedure and they will not be the ones&#xD;
      following up on the patients for study purposes.&#xD;
&#xD;
      End of the procedure After surgery, the patients will be transferred to the recovery room. A&#xD;
      standard postoperative analgesic regimen will be used in all patients with Numeric Rating&#xD;
      Scale (NRS) &gt;= 3.&#xD;
&#xD;
      As long as the patient is in the hospital, she will receive paracetamol 1g every 6 hours,&#xD;
      preferably given orally. If, despite this regimen, the NRS score is higher than 3, they will&#xD;
      receive tramadol 100mg IV + alizapride 50 mg. There will be a re-evaluation after 30 minutes.&#xD;
      If the NRS is still higher than 3, an anaesthesiologist will be consulted and a subcutaneous&#xD;
      dose of morphine will be given. The dose will be 5 mg if the body weight of the patient is&#xD;
      less than 90 kg and the patient is less than 70 years old. In a patient heavier than 90 kg&#xD;
      and younger than 70 years, the dose will be 10mg morphine subcutaneously.&#xD;
&#xD;
      The nurses of the day hospital will complete the first page(s) of the patient's&#xD;
      questionnaire.&#xD;
&#xD;
      Later that day the patient will be discharged from the hospital if all the discharge criteria&#xD;
      are met according to standard operating procedures.&#xD;
&#xD;
      When going home all patients receive a map with their questionnaire, a prescription for&#xD;
      paracetamol 1g if necessary, max 4 times a day, and a last reminder to not forget about the&#xD;
      questionnaire. In this study, we will focus about the first week postoperatively.&#xD;
&#xD;
      6. Questionnaire In total 7 parameters will be questioned: abdominal pain, shoulder pain,&#xD;
      nausea, vomiting, itching, urinating and activity level. The questionnaire that will be given&#xD;
      to the patients consists of an introduction page and 5 identical questionnaires. Assessment&#xD;
      will take place at respectively 1 h, 2 h, 6 h, 24 h and 1 w postoperatively. Abdominal pain&#xD;
      will be scored by the patients using the numeric rating scale. The patients will be asked to&#xD;
      rate the severity of pain via NRS ranging from no pain (score 0) to the worst possible pain&#xD;
      (score 10).&#xD;
&#xD;
      This method is explained in the introduction page and is the method of choice to evaluate&#xD;
      pain in the recovery room. This means that all the patients will already be familiar with the&#xD;
      scoring system before going home. Intra-abdominal pain will be assessed during rest and&#xD;
      during an effort, for example coughing. In the postoperative period, the time to first&#xD;
      analgesic administration and total analgesic requirements (paracetamol, tramadol and&#xD;
      morphine) will be recorded.&#xD;
&#xD;
      For the other parameters, our interests lie in the presence or absence of these elements so&#xD;
      we chose for a simple &quot;yes&quot; or &quot;no&quot; question.&#xD;
&#xD;
      The individuals filling in the questionnaires, the patients or the nurses of the recovery&#xD;
      room will always be blinded to the study groups, as will the nurse contacting the patients&#xD;
      for the follow up. The research nurses will contact the patients through telephone 24 h after&#xD;
      surgery and again 1 week after surgery to get the answers of the questionnaires. They will be&#xD;
      unaware of the study group the patient was subdivided into. The responses will be recorded&#xD;
      and analysed by members of the research group. If the patients are not pain free after one&#xD;
      week, we will contact them again after one month. After that, they will be called once a&#xD;
      month until they are pain free or 6 months have passed. Postoperative pain lasting more than&#xD;
      one week could be and indicator for the onset of chronic pain. (13) However, this topic will&#xD;
      need additional research that, for the moment, is beyond the scope of our investigation.&#xD;
&#xD;
      7. Statistics: Comparison of the categorical or ordinal variables will be performed using Chi&#xD;
      square or Fisher exact test and relative risk with 95 % confidence intervals as appropriate&#xD;
      Continuous variables will be presented in median values and will be compared using ANOVA.&#xD;
      Multivariate logistic regression analysis will be performed. P values of less than 0.05 will&#xD;
      be regarded statistically significant. All the calculations will be performed with the SPSS&#xD;
      11.0 statistical package (SPSS, Inc., Chicago, IL) (Dupont WD, Plummer WD,&#xD;
      http://www.spss.com). According to that the sample size should be at least 16 cases for each&#xD;
      group when we want the power of the study to be 80%.æ&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>We will be using ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the patient belongs to, this dose will be given in full by either local injection at the trocar entry points or by intraperitoneal injection or it will be divided between both injection sites</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The participant won't know to what study group they are assigned and will be under general anaesthesia. The study medication will be prepared in the operating room right before use. This means that neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. The investigators filling in the questionnaires, the patients or the nurses of the recovery room will always be blinded to the study groups, as will the nurse contacting the patients for the follow up.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominale Pain scores postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>Numeric rating scale NRS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>need of pain medication postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>note in file</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative nausea and vomiting</measure>
    <time_frame>one week</time_frame>
    <description>score yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>shoulder pain postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>score yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>itching postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>score yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>problems with urinating postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>score yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity level postoperatively: return to normal</measure>
    <time_frame>one week</time_frame>
    <description>score yes/no</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>group A - combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A patients will receive intra-abdominal instillation 0.75% Ropivacaine 2 mg / kg in 200 ml of NaCl through the trocars and 2) Infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 1 mg / kg in 20 ml of NaCl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B patients will receive infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 3 mg / kg in 20 ml of NaCl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C - instillation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group C patients will receive intra-abdominal instillation 0.75% Ropivacaine 3 mg / kg in 200 ml of NaCl through the trocars.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combination</intervention_name>
    <description>instillation and infiltration of ropivacaine</description>
    <arm_group_label>group A - combination</arm_group_label>
    <other_name>ropivacaine intraperitoneal and local</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>infiltration</intervention_name>
    <description>local infiltration ropivacaine</description>
    <arm_group_label>Group B - infiltration</arm_group_label>
    <other_name>ropivacaine local</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>instillation</intervention_name>
    <description>intraperitoneal ropivacaine instillation</description>
    <arm_group_label>Group C - instillation</arm_group_label>
    <other_name>intraperitoneal ropivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.&#xD;
&#xD;
          2. Successful laparoscopy without surgical or anesthetic complications.&#xD;
&#xD;
          3. Female&#xD;
&#xD;
          4. 18-70 years&#xD;
&#xD;
          5. ASA I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to anaesthetics of the amide-type&#xD;
&#xD;
          2. Obesity, BMI &gt; 35&#xD;
&#xD;
          3. Patients with chronic use of analgesics / chronic pain&#xD;
&#xD;
          4. Patients with an abnormal liver function&#xD;
&#xD;
          5. Urgent surgical procedures&#xD;
&#xD;
          6. Pregnancy (this means we only include patients who use contraceptives, are sterilized,&#xD;
             have a negative dipstick testing or a negative serum testing or patients who are&#xD;
             postmenopausal)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UZA</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 28, 2018</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Prof Yves Jacquemyn</investigator_full_name>
    <investigator_title>Professor Jacquemyn</investigator_title>
  </responsible_party>
  <keyword>ropivacaine</keyword>
  <keyword>laparoscopy</keyword>
  <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>Ropivacaine</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/NCT04459026
org study id: ropivacaine
nct id: NCT04459026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the effect of different routes of local anaesthesia
      administration in laparoscopic procedures to reduce post-operative pain (intra-peritoneal
      infusion of Ropivacaine 0.75%, port site injection of Ropivacaine 0.75% or a combination of
      both techniques), through a randomized one-center double-blinded study.
Research Question What is the best route of Ropivacaine administration in laparoscopic
      procedures in decreasing post-operative pain? Is it port site injection, intra-peritoneal
      instillation of local anesthetics or is it a combination of both routes? Our hypothesis is
      that a combination of port site injection and intra-peritoneal instillation of local
      anesthetics will be more effective in lowering pain the first 24 hours after surgery.

      3. Characteristics of the patient population Inclusion criteria

        1. Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.

        2. Successful laparoscopy without surgical or anesthetic complications.

        3. Female

        4. 18-70 years

        5. ASA( American Society of Anesthesia) I-II Exclusion criteria

      (1) Hypersensitivity to anaesthetics of the amide-type (2) Obesity, BMI > 35 (3) Patients
      with chronic use of analgesics / chronic pain (4) Patients with an abnormal liver function
      (5) Urgent surgical procedures (6) Pregnancy (this means we only include patients who use
      contraceptives, are sterilized, have a negative dipstick testing or a negative serum testing
      or patients who are postmenopausal) 4. Characteristics of the treatment We will be using
      ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose
      of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the
      patient belongs to, this dose will be given in full by either local injection at the trocar
      entry points or by intraperitoneal injection or it will be divided between both injection
      sites, respectively 1mg at the trocar sites and 2mg intraperitoneal. The unequal dose
      distribution is based on the surface area the local anaesthetic has to cover.

      5. Methodology Anaesthetic management will be standardized for each person. The anaesthetist
      will insert an intravenous line and connect the patient to the monitor. We will be using
      routine intraoperative monitoring devices such as an electrocardiograph, a pulse oximetry and
      a non-invasive blood pressure monitor. The patient is preoxygenated with 100% O2 before
      induction.

      Anaesthetic protocol

      Induction:

        -  fentanyl 2μg/kg

        -  Propofol TCI marsh model 6μg/ml - titration based on effect

        -  Rocuronium 0.5mg/kg

      Maintenance:

      - Propofol TCI Marsh model: 4μ/ml - (8-12mg/kg/u) - titration based on effect, blood pressure
      and heart rate.

      Analgesia intraoperatively:

        -  Ketorolac 30mg at induction (if no contraindications; and > 60kg; if the patient weight
           is < 60kg the dose will be lowered to 20mg)

        -  Paracetamol 1g one half hour before the end of the surgery Different study groups

      At the end of the successful gynaecologic laparoscopy, patients will receive the additional
      pain management according to their randomly assigned study group:

        -  Group A patients will receive 1) intra-abdominal instillation 0.75% Ropivacaine 2 mg /
           kg in 200 ml of NaCl through the trocars and 2) Infiltration of the surgical wounds at
           the trocar sites with 0.75% Ropivacaine 1 mg / kg in 20 ml of NaCl (Sodiumchloride)

        -  Group B patients will receive infiltration of the surgical wounds at the trocar sites
           with 0.75% Ropivacaine 3 mg / kg in 20 ml of NaCl.

        -  Group C patients will receive intra-abdominal instillation 0.75% Ropivacaine 3 mg / kg
           in 200 ml of NaCl through the trocars.

      Suction and aspiration is avoided after instillation of local anaesthetic intra-abdominal in
      group A and C.

      The study medication will be prepared in the operating room right before use. This means that
      neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. This
      isn't a problem since it is already at the end of the procedure and they will not be the ones
      following up on the patients for study purposes.

      End of the procedure After surgery, the patients will be transferred to the recovery room. A
      standard postoperative analgesic regimen will be used in all patients with Numeric Rating
      Scale (NRS) >= 3.

      As long as the patient is in the hospital, she will receive paracetamol 1g every 6 hours,
      preferably given orally. If, despite this regimen, the NRS score is higher than 3, they will
      receive tramadol 100mg IV + alizapride 50 mg. There will be a re-evaluation after 30 minutes.
      If the NRS is still higher than 3, an anaesthesiologist will be consulted and a subcutaneous
      dose of morphine will be given. The dose will be 5 mg if the body weight of the patient is
      less than 90 kg and the patient is less than 70 years old. In a patient heavier than 90 kg
      and younger than 70 years, the dose will be 10mg morphine subcutaneously.

      The nurses of the day hospital will complete the first page(s) of the patient's
      questionnaire.

      Later that day the patient will be discharged from the hospital if all the discharge criteria
      are met according to standard operating procedures.

      When going home all patients receive a map with their questionnaire, a prescription for
      paracetamol 1g if necessary, max 4 times a day, and a last reminder to not forget about the
      questionnaire. In this study, we will focus about the first week postoperatively.

      6. Questionnaire In total 7 parameters will be questioned: abdominal pain, shoulder pain,
      nausea, vomiting, itching, urinating and activity level. The questionnaire that will be given
      to the patients consists of an introduction page and 5 identical questionnaires. Assessment
      will take place at respectively 1 h, 2 h, 6 h, 24 h and 1 w postoperatively. Abdominal pain
      will be scored by the patients using the numeric rating scale. The patients will be asked to
      rate the severity of pain via NRS ranging from no pain (score 0) to the worst possible pain
      (score 10).

      This method is explained in the introduction page and is the method of choice to evaluate
      pain in the recovery room. This means that all the patients will already be familiar with the
      scoring system before going home. Intra-abdominal pain will be assessed during rest and
      during an effort, for example coughing. In the postoperative period, the time to first
      analgesic administration and total analgesic requirements (paracetamol, tramadol and
      morphine) will be recorded.

      For the other parameters, our interests lie in the presence or absence of these elements so
      we chose for a simple "yes" or "no" question.

      The individuals filling in the questionnaires, the patients or the nurses of the recovery
      room will always be blinded to the study groups, as will the nurse contacting the patients
      for the follow up. The research nurses will contact the patients through telephone 24 h after
      surgery and again 1 week after surgery to get the answers of the questionnaires. They will be
      unaware of the study group the patient was subdivided into. The responses will be recorded
      and analysed by members of the research group. If the patients are not pain free after one
      week, we will contact them again after one month. After that, they will be called once a
      month until they are pain free or 6 months have passed. Postoperative pain lasting more than
      one week could be and indicator for the onset of chronic pain. (13) However, this topic will
      need additional research that, for the moment, is beyond the scope of our investigation.

      7. Statistics: Comparison of the categorical or ordinal variables will be performed using Chi
      square or Fisher exact test and relative risk with 95 % confidence intervals as appropriate
      Continuous variables will be presented in median values and will be compared using ANOVA.
      Multivariate logistic regression analysis will be performed. P values of less than 0.05 will
      be regarded statistically significant. All the calculations will be performed with the SPSS
      11.0 statistical package (SPSS, Inc., Chicago, IL) (Dupont WD, Plummer WD,
      http://www.spss.com). According to that the sample size should be at least 16 cases for each
      group when we want the power of the study to be 80%.æ
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will be using ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the patient belongs to, this dose will be given in full by either local injection at the trocar entry points or by intraperitoneal injection or it will be divided between both injection sites
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The participant won't know to what study group they are assigned and will be under general anaesthesia. The study medication will be prepared in the operating room right before use. This means that neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. The investigators filling in the questionnaires, the patients or the nurses of the recovery room will always be blinded to the study groups, as will the nurse contacting the patients for the follow up.
measure: Abdominale Pain scores postoperatively
time frame: one week
description: Numeric rating scale NRS
measure: need of pain medication postoperatively
time frame: one week
description: note in file
measure: postoperative nausea and vomiting
time frame: one week
description: score yes/no
measure: shoulder pain postoperatively
time frame: one week
description: score yes/no
measure: itching postoperatively
time frame: one week
description: score yes/no
measure: problems with urinating postoperatively
time frame: one week
description: score yes/no
measure: Activity level postoperatively: return to normal
time frame: one week
description: score yes/no
arm group label: group A - combination
arm group type: Experimental
description: Group A patients will receive intra-abdominal instillation 0.75% Ropivacaine 2 mg / kg in 200 ml of NaCl through the trocars and 2) Infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 1 mg / kg in 20 ml of NaCl
arm group label: Group B - infiltration
arm group type: Experimental
description: Group B patients will receive infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 3 mg / kg in 20 ml of NaCl.
arm group label: Group C - instillation
arm group type: Active Comparator
description: Group C patients will receive intra-abdominal instillation 0.75% Ropivacaine 3 mg / kg in 200 ml of NaCl through the trocars.
intervention type: Procedure
intervention name: combination
description: instillation and infiltration of ropivacaine
arm group label: group A - combination
other name: ropivacaine intraperitoneal and local
intervention type: Procedure
intervention name: infiltration
description: local infiltration ropivacaine
arm group label: Group B - infiltration
other name: ropivacaine local
intervention type: Procedure
intervention name: instillation
description: intraperitoneal ropivacaine instillation
arm group label: Group C - instillation
other name: intraperitoneal ropivacaine
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Prof Yves Jacquemyn
investigator title: Professor Jacquemyn
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: Undecided