Perioperative Analgesic Efficiency of Quadratus Lumborum Block vs Epidural in Radical Cystectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is performed to measure the perioperative analgesic efficiency of bilateral
      quadratus lumborum block versus epidural analgesia in bladder cancer patients undergoing
      radical cystectomy
    

Detailed description: 
      1. Background and rationale:

           Bladder cancer is the ninth most common cancer in the world while being considerably
           common in both developed and developing countries. Bladder cancer is the most common
           malignancy among Egyptian males and it had been previously attributed to Schistosoma
           infection, a major risk factor for squamous cell carcinoma (SCC). Recently, transitional
           cell carcinoma (TCC) incidence has been increasing while SCC has declined. Exposures to
           tobacco smoke, occupational toxins, and environmental sources of heavy metals such as
           arsenic are the major reported risk factors for TCC .

           Acute perioperative pain management has been a matter of attention especially in major
           abdominal surgeries like radical cystectomy. Poor perioperative pain management
           especially with major abdominal surgeries can lead to deterioration of both
           physiological and psychological status of the patient leading to anxiety, stress, and
           patient's dissatisfaction while also leading to severe abdominal pain and diminished
           respiratory functions due to impaired function of accessory respiratory muscles which
           may precipitate shallow breathing, atelectasis, retained secretions, and also lack of
           patient's cooperation.

           Adequate multimodal perioperative pain management improves patient's recovery and
           survival on a general prospective due to decreased surgical stress response leading to
           better immunological functions and coagulation profile, and hence improving the outcome
           of the surgery.

           Perioperative epidural analgesia has been associated with improved overall survival but
           not reduced cancer recurrence. However, patients receiving epidural analgesia with or
           without general anesthesia have shown longer survival over 5 years period
           postoperatively than those receiving general anesthesia alone which can be related to
           better immunological profile and decreased stress response in regional anesthesia group
           of patients.

           Epidural analgesia for perioperative pain management has proven earlier recovery in post
           anesthesia care unit (PACU) with better pain and respiratory tolerance and decreased
           need for intravenous opioid administration. Perioperative continuous epidural analgesia
           was found to reduce hospital stay for patients undergoing major abdominal surgeries.

           Quadratus lumborum (QL) block was first described by Blanco and was previously called
           (the posterior approach of TAP block). Volunteers for QL spread of local anesthetic have
           shown a good spread of local anesthetics from T4 to L1 proving adequacy of QL block for
           analgesia over both posterior and anterior abdominal region surgeries. Further studies
           are being made to assess the adequacy of QL block as an analgesic technique for major
           abdominal surgeries.

           Perioperative analgesia using QL block with the ipsilateral technique following minor
           abdominal surgeries has shown decreased need for intravenous administration of opioids
           and has also shown promising results for adequate perioperative analgesia after major
           abdominal surgeries.

           Many reports have suggested that QL block can provide adequate analgesia not only for
           abdominal wall somatic pain but for severe visceral pain as well. The mechanism for
           visceral pain analgesia is not fully understood but it is suggested to be due to
           paravertebral spread of the injected local anesthetic.

           Early post-operative ambulation of bladder cancer patients undergoing radical cystectomy
           can be achieved using QL block which have a positive impact on both surgical outcome and
           patient survival. Radical cystectomy patients receiving QL block have shown decreased
           hospital stay with earlier discharge due to adequate long lasting analgesia and early
           ambulation.

        2. Objectives:

           Primary Outcome:

           To test feasibility, efficiency, and safety of continuous perioperative QL block for
           perioperative pain management in bladder cancer patients undergoing radical cystectomy
           in comparison to continuous perioperative epidural analgesia for the same surgical
           procedure.

        3. Study Design:

             -  This study will be Prospective Randomized Controlled Study.

             -  The study will be submitted to the Institutional Review Board (IRB) for review.

        4. List of Correlative Studies:

             -  Blanco R, Ansari T, Girgis E (2015): Quadratus lumborum block for postoperative
                pain after caesarean section: a randomised controlled trial. European Journal of
                Anaesthesiology (EJA). 32(11):812-8.

             -  Blanco R, Ansari T, Riad W, & Shetty N (2016). Quadratus lumborum block versus
                transversus abdominis plane block for postoperative pain after cesarean delivery: a
                randomized controlled trial. Regional anesthesia and pain medicine, 41(6), 757-762.

        5. Study Methods:

           • Interventions:

           Pre-interventional preparation:

             -  Sedation for all patients prior to analgesic procedure at preoperative preparatory
                room using midazolam (0.02 mg/kg) intravenously.

             -  Patients will be re-instructed about our anesthetic procedure steps according to
                each group.

             -  Standard ASA monitoring for all patients before and during the anesthetic
                procedure.

             -  Anesthetic procedure will start at the preoperative preparatory room in the form of
                regional block according to each of the study groups with catheter insertion and
                assessment of procedure success as discussed later.

             -  Patients will be subjected to either quadratus lumborum block or epidural catheter
                insertion and analgesia as described later on.

             -  Success of catheter insertion will be evaluated using 5ml of lidocaine 5% per
                catheter injection before proceeding with regular anesthetic doses. Analgesia level
                of T4 will be satisfactory for permitting transfer of patients to OR to proceed
                with general anesthesia and surgical procedure.

             -  Routine assessment of all patients including assessment of patient's medical
                history, clinical examination, laboratory investigations (kidney and liver
                functions, CBC, and coagulation profile), ECG will be conducted on all patients
                above 40 years old and echocardiography for patients with suspected
                cardiomyopathies by medical history or preoperative examination. Chest X-ray for
                all patients suspected for respiratory diseases.

             -  Patients will be subjected to continuous monitoring during surgery for any further
                complications related to anesthetic techniques and to surgery itself.

             -  Patients will be monitored at PACU post-operatively to ensure hemodynamic
                stability, adequate analgesia, and attention for any possible complications that
                may occur due to anesthetic or surgical techniques used.

             -  Patients will be discharged using the modified Aldrete's scoring system, a score of
                9 or more will be sufficient for safe discharge of the patient to ward for further
                monitoring, continuation of analgesic techniques, and assessment of adequacy of
                analgesia post-operatively.

             -  Patients' discharge time till reaching sufficient Aldrete's score for each study
                group will be calculated and included in the study parameters for further
                assessment of safety and efficiency of analgesic techniques used.

                • Possible risks:

             -  Orthostatic hypotension.

             -  Hemodynamic instability (e.g. bradycardia, ECG changes, tachycardia).

             -  Local anesthetic toxicity.

                  -  Source of Funding:

           No source of funding.

             -  Time plan:

                  -  The study is to be started in 2018 and is expected to be finished in 2020.

                  -  The expected publishing date is 2020.

             -  Benefits from the study:

           To test feasibility, efficiency, and safety of continuous perioperative QL block for
           perioperative pain management in bladder cancer patients undergoing radical cystectomy
           in comparison to continuous perioperative epidural analgesia for the same surgical
           procedure.

           • Possible Risk:

             -  Orthostatic hypotension.

             -  Hemodynamic instability (e.g. bradycardia, ECG changes, tachycardia).

             -  Local anesthetic toxicity.

        6. Protection of privacy and confidentiality of patients' information:

           Data collection and presentation will be anonymous and both privacy and confidentiality
           will be protected to the maximal possible standards.

        7. Publication policy:

      Any article arising from this work will carry the names of all participants with the name
      orders according to the degree of contribution to data interpretation and manuscript writing.
      Additional external authors may be added if they add to the content and qualify for
      authorship by the international standards.
    

Intervention name(s): Quadratus Lumborum Block Using Bupivacaine 0.2%; Epidural Analgesia Using Bupivacaine 0.25%
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided transmuscular approach for quadratus lumborum block using an 18 gauge Touhy's epidural needle to insert the catheter. Normal saline 5 mL will be used to identify that plane. A volume of 20 ml of 0.25% of Bupivacaine bolus will be injected in that plane just over QL. This will be followed by epidural catheter insertion to facilitate continuous infusion. A similar procedure will be performed on the other side. A continuous infusion of 0.2% Bupivacaine at 5 ml/h will be administered to the patient.
This transmuscular quadratus lumborum (TQL) block, has been suggested to be a simple and perhaps safer alternative to the anterior approach as was described for the original QL block; With Patients placed in sitting position, puncture site will be identified at (T8-9, T9-10, or T10-11) intervertebral spaces. Using aseptic conditions, an 18G Tuohy epidural needle will be used to insert epidural catheter as appropriate.
Induction of epidural analgesia with 10-15 ml bupivacaine 0.25% preoperatively with top up doses of 5-7 ml bupivacaine 0.25% or equivalent administered judiciously till we achieve analgesic level of T4 to L1. The calculated top up doses will be administered each hour using bupivacaine 0.25% or by using a continuous infusion syringe pump for equivalent doses
Other intervention name(s): Transmuscular QL; Thoracic Epidural
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group (A): 17 cases will be subjected to bilateral Ultrasound-guided Quadratus lumborum block through bilateral catheter insertion for perioperative analgesia.
Group (B): 17 cases will be subjected to epidural catheter insertion for perioperative analgesia (as a control group).
This number is to be increased to 34 patients (17 patients in each group) to account for the necessity to use non-parametric test. Sample size was calculated using G*Power program (University of Düsseldorf, Düsseldorf, Germany) 17, 20, 21.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: quadratus lumborum block; epidural analgesia; bladder cancer; radical cystectomy