Comparison of Administation Routes of Ropivacaine
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): combination; infiltration; instillation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): instillation and infiltration of ropivacaine; local infiltration ropivacaine; intraperitoneal ropivacaine instillation
Other intervention name(s): ropivacaine intraperitoneal and local; ropivacaine local; intraperitoneal ropivacaine
Intervention MeSH terms: Ropivacaine
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
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ropivacaine; laparoscopy