Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the study to compare between intraoperative and postoperative analgesic effect of
      ultrasound guided continuous quadratus lumborum block and continuous thoracic paravertebral
      block in patients operated for radical cystectomy (primary outcome). Side effects, length of
      hospital stay and patient satisfaction(secondary outcome).
    

Detailed description: 
      The analgesic efficacy of ultrasound guided continuous quadratus lumborum block versus
      continuous paravertebral block in radical cystectomy

      Protocol of a thesis submitted to the Faculty of Medicine University of Alexandria In partial
      fulfillment of the requirements of the degree of Master of Anaesthesia And Surgical Intensive
      Care

      By

      Amr Ragheb Hieba MBBCh, Alex. Resident Alexandria University Hospitals Department of
      Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria 2017

      SUPERVISORS

      Prof. Dr. Ramadan Abdelazeem Ammar Professor of Anaesthesia and Surgical Intensive care,
      Faculty of Medicine University of Alexandria

      CO-SUPERVISOR

      Dr.Mohamad Hazem Ibrahim Ahmed Sabry

      Lecturer in Anaesthesia and Surgical Intensive Care, Faculty of Medicine, University of
      Alexandria. For his experience in regional anaesthesia.

      INTRODUCTION Bladder cancer is the most common malignancy of the urinary tract and radical
      cystectomy remains the gold standard for management of muscle invasive disease.(1) Despite
      improvement in perioperative period it remains associated with a greater morbidity and more
      prolonged inpatient stay than other urological studies. Bowel complications particularly
      ileus are amongst the commonest problems that patients experience.)2,3) Pain is common after
      major abdominal surgeries.Uncontrolled postoperative pain increases the incidence of
      postoperative complications.Multimodal analgesia can improve pain control in postoperative
      period and reduces complications that may arise from using a single mode of analgesia.(4)
      Effective regional anesthesia techniques for abdominal surgery include epidural,paravertebral
      , transverses abdominis plane (TAP) block .multiple approaches have been used for TAP block
      with ultrasound guided midaxillary approach but are sometimes patchy with variable wound
      coverage . the use of ultrasound approach at the level of quadratus lumborum muscle is new
      and may provide wider spread of the local anesthetic ( T5-L1) than TAP and paravertebral
      blocks.(5) Studies of quadratus lumborum block show its use in postoperative analgesia in
      major abdominal surgery. Results have shown widespread and long-lasting analgesic effect
      after ovarian surgery and resulted in lower peak arterial concentrations of injected
      bupivacaine as compared to lateral TAPB.(6)

      Similarly, thoracic paravertebral block (PVB) has been demonstrated to provide effective
      postoperative analgesia in patients undergoing minor and major abdominal surgery by blocking
      sensory innervations of the abdominal wall. PVB significantly reduces the need for
      supplemental opioid administration, reduces postoperative nausea and vomiting (PONV), and in
      some patient groups shortens length of hospital stay. Although PVB has been demonstrated to
      be effective in patients undergoing abdominal and thoracic surgery, its analgesic efficacy
      after major gynecological surgery has not, as yet, been reported .(7,8) Studies have shown
      that regional anesthetic technique for cancer surgery could affect recurrence or metastasis.
      This retrospective study suggests that paravertebral anaesthesia and analgesia for breast
      cancer surgery reduces the risk of recurrence or metastasis during the initial years of
      follow up. (9)

      AIM OF THE WORK The aim of the study to compare between intraoperative and postoperative
      analgesic effect of ultrasound guided continuous quadratus lumborum block and continuous
      thoracic paravertebral block in patients operated for radical cystectomy (primary outcome).
      Side effects, length of hospital stay and patient satisfaction(secondary outcome).

      PATIENTS

        -  After approval of Local Ethics Committee, and written informed consent from each patient
           or oral consent if illiteracy prevent a written consent, The present study will be
           carried out in the Urosurgery department at Alexandria Main University hospital on 60
           adult patients scheduled for radical cystectomy, males and females.

        -  Patients will be randomly assigned into two equal groups (30 patients each) according to
           type of the block:

             1. Group I:

                Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg
                bupivacaine 0.25% on each side with catheter insertion for maintenance doses
                0.1ml/kg/hr on each side.

             2. Group II:

      Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg
      bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on
      each side.

      Exclusion Criteria:

        -  Patient refusal.

        -  Coagulopathy/ thrombocytopenia.

        -  Localized infection at the proposed site of injection.

        -  Inability to comprehend the scoring systems to be employed due to mental problems.

        -  known allergy to the drugs to be used (local anesthetics, opioids)

        -  Opioid tolerance/ dependence

        -  Back abnormalities.

        -  Neurological deficits

      METHODS

      Pre-operative assessment and preparation:

        1. History taking ,

        2. Clinical examination ,

        3. All needed laboratory investigations. The technique ofanaesthesiawill be explained to
           patients.

      Premedication:

      All patients will be premedicated with midazolam 0.05 mg/kg IV 30 min before surgery.

      Anaesthetic technique:

      A multichannel monitor will be connected to the patient to display continuous
      electrocardiography monitoring for heart rate (beat/min) and detection of dysrhythmias,
      noninvasive arterial blood pressure (mmHg), respiratory rate and arterial oxygen saturation
      (SpO2) .

      Baseline monitoring data (blood pressure, heart rate, respiratory rate and oxygen saturation)
      will be recorded.

      Induction of anaesthesia will be carried out with fentanyl citrate (1µ/kg)i.v, propofol
      2mg/kg i.v will be injected till loss of verbal communication and endotracheal intubation
      will be facilitated by rocuronium bromide 0.6mg/kg.

      Ventilation will be maintained with Drager fabius plus ventilator as IPPV volume control.

      Anaesthesia will be maintained with Isoflurane in 100% oxygen, intermittent boluses of
      Rocuroniun (0.1mg/kg).

      Technique of QL block group After induction of general anesthesia,the patient will be
      positioned for lateral position to obtain appropriate view of QL and thoracic PV
      block.Aseptic measures will be taken by wearing sterile gown and sterile drapes .Ultrasound
      will be used with linear probe covered with sterile elastic sheath. Probe will be placed
      horizontally between the costal margin and iliac crest. The 3 muscle layer of the abdominal
      wall will be identified as external oblique, internal oblique , transverses abdominis muscles
      .The fascia surrounding transverses abdominis will be tracked until its origin, where
      transverses abdominis muscle merge with thoracolumbar fascia surrounding quadratus lumborum
      muscle .

      18 G 3 inch long non stimulating echoic needle will be inserted in plane with the ultrasound
      probe and targeted toward fascia transversalis . Normal saline 3 ml will be used to identify
      the splitting of the fascia .Then injection of 0.3 ml/kg bupivacaine 0.25% in the same plane
      after negative aspiration.

      This will be seen spreading around quadratus lumborum muscle. Echogenic catheter will be
      advanced 7 cm beyond the tip of the needle with minimal resistance.(10) Maintenance will be
      0.1 ml\kg\hr. The procedure will be repeated on the other side after placing the patient in
      the opposite position.

      Technique for thoracic paravertebral block After general anesthesia, the patient will be
      positioned to lateral position. Under strict aseptic technique, Ultrasound will be used with
      linear probe covered with sterile elastic sheath .Probe is applied longitudinal at level of
      T10.

      For most of patients, the depth of field is set to 3 cm to start scanning. The transverse
      processes and ribs are shown as hyperechoic structures with acoustic shadowing between them.

      Once the transverse processes and ribs are identified, the transducer is moved slightly
      cauded into the intercostals space between adjacent ribs to identify the thoracic PVS and
      adjoining intercostal space.

      The PVS appears as a wedge shaped hypoechoic layer demarcated by the hyperechoic reflections
      of the pleura below and internal intercostal membrane above.

      The hyperechoic line of the pleura and underlying hyperechoic air artifacts move with
      respiration .the goal of the technique is to insert the needle into PVS to inject 0.3ml∕kg
      bupivacaine 0.25% .(11) Echogenic catheter is advanced 7 cm beyond the tip of the needle with
      minimal resistance.

      Maintenance will be 0.1ml\kg\hr. The same procedure will be repeated on the other side after
      placing the patient in the opposite position .

      Measurements

      The following parameters will be measured :

      A- Hemodynamic parameters :

        -  Heart rate (beat per minute )

        -  Mean arterial blood pressure (mmHg)

        -  Oxygen saturation using pulse oximetry . All previous parameters will be continuously
           monitored and recorded at the following periods : preoperative , every 30 minutes
           intraoperative till the end of surgery and every 12 hrs postoperative for 3 days .

      B - Intensity of postoperative pain :

      Patients will be asked to quantify their pain on a visual analogue scale between 0 - 10 with
      (0) representing no pain and ( 10 ) representing the worst imaginable pain .(12)

      It will be measured postoperative every 12hrs for 3 days .

      C - Analgesic requirements :

        -  First request of analgesia .

        -  Rescue analgesia in the form of nalbuphine 0.1 mg / kg will be given when VAS score ≥4 .
           VAS to be assessed every 12 hrs and give rescue analgesia accordingly .

        -  Total dose of analgesia given .

      ETHICS OF RESEARCH

      Research on human or human products:

      Prospective study: Informed consent will be taken from patients. In case of incompetent
      patients the informed consent will be taken from the guardians.

      All drugs used in the research are approved by the Egyptian Ministry of Health

      RESULTS Results will be put in tables. Appropriate statistical analysis test will be done.

      DISCUSSION The results of the study will be discussed in view of achievement of the aim and
      will be compared to the other studies.
    

Intervention name(s): US guided Quadratus Lumborum block; US guided Paravertebral block.
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.; Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded randomized study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment