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Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery

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ClinicalTrials.gov Identifier: NCT03771339
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Brief Summary:
Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Continuous Epidural analgesia Procedure: Bilateral Quadratus Lumborum block Not Applicable

Detailed Description:
Epidural analgesia is the main choice of analgesia following kidney transplant surgery. However, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum (QL) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of QL block techniques for patients who underwent kidney transplant surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-Guided Quadratus Lumborum Block and Epidural Analgesia for Postoperative Pain Management After Renal Transplantation
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous Epidural Analgesia
Continuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours
Procedure: Continuous Epidural analgesia
Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy

Experimental: Bilateral Quadratus Lumborum Block
Bilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery
Procedure: Bilateral Quadratus Lumborum block
Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 24 hours ]
    pain measurement using Visual Analogue Scale (VAS) presented with horisontal line 0-100 mm for no pain to the worst pain, with range 0-30 mm for none to mild pain, 31-70 mm for moderate pain, 71-100 mm for severe pain


Secondary Outcome Measures :
  1. Morphine consumption [ Time Frame: 24 hours ]
    addtional analgesia required

  2. Blood ropivacaine level [ Time Frame: 24 hours ]
    Arterial blood sample of all subjects will be withdrawn 2 mL from the arterial line at baseline, 30,45,60 minute, and at 2,4,6,12, 18, 22 hours, and will be used for ropivacaine blood level measurements using High Performance Liquid Chromatography (HPLC), to measure Total plasma ropivacaine concentration (Cstop), maximum plasma concentration (Cmax), time of maximum palsma concentration, area under the curve (AUC)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing elective kidney transplant laparotomy surgery
  • Agrees to participate in research
  • BMI < 30 kg/m2

Exclusion Criteria:

  • Declines to participate in research
  • Contraindications to intervention procedures (epidural or quadratus lumborum block)
  • History of local anaesthetic allergy
  • Systemic allergic reactions, anaphylactic reaction, cardiac arrest
  • Failure of intervention procedures (epidural or quadratus lumborum block)
  • Intraoperative complications (massive bleeding, hypotension)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771339


Contacts
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Contact: Dita Aditianingsih, M.D. +628151819244 ditaaditiaa@gmail.com
Contact: Ronald Aritonang, M.D. +628118820050 ronald.christian.aa@gmail.com

Locations
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Indonesia
Rumah Sakit Cipto Mangunkusumo Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Dita Aditianingsih, M.D.    +628151819244    ditaaditiaa@gmail.com   
Contact: Ronald Aritonang, M.D.    +628118820050    ronald.christian.aa@gmail.com   
Principal Investigator: Dita Aditianingsih, M.D.         
Principal Investigator: Ronald Aritonang, M.D.         
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dita Aditianingsih, M.D. Indonesia University

Publications:
Mochtar CA, Alfarissi F, Soeroto AA, Hamid ARAH, Wahyudi I, Marbun MBH, et al. Milestones of kidney transplantation in Indonesia. Med J Indones. 2017 Nov 27;26(3):229.
Kakaei F, Nikeghbalian S, Ali S. Kidney Transplantation Techniques. In: Rath T, editor. Current Issues and Future Direction in Kidney Transplantation [Internet]. InTech; 2013 [cited 2018 Jun 6]. Available from: http://www.intechopen.com/books/current-issues-and-future-direction-in-kidney-transplantation/kidney-transplantation-techniques
Abdelsalam K., Sultan S. Effectiveness of ultrasound-guided transversus abdominis plane block for intraoperative and postoperative analgesia in kidney transplantation. Ain-Shams J Anaesthesiol. 2015;8(1):140.
S Martinez B. Anesthesia for Kidney Transplantation-A Review. J Anesth Clin Res [Internet]. 2013 [cited 2018 Jun 6];04(01). Available from: https://www.omicsonline.org/anesthesia-for-kidney-transplantation-a-review-2155-6148.1000270.php?aid=11555
Ashok J, Mayur M, Asit K P, Neelam S.Postoperative Analgesia by Transmuscular Quadratus Lumborum Block Catheters. J Anest & Inten Care Med. 2016; 1(3) : 555562
Agrawal P, Farag E. Ultrasound-guided quadratus lumborum and subcostal transversus abdominis plane blocks. Tech Reg Anesth Pain Manag. 2014 Oct;18(4):163-5
Brull R, MacFarlane AJR, Chan VWS. Spinal, Epidural, and Caudal Anesthesia. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's anesthesia. Eighth edition. Philadelphia, PA: Elsevier/Saunders; 2015. p. 1684-720
Butterworth JF, Mackey DC, Wasnick JD, Morgan GE, Mikhail MS, Morgan GE. Spinal, Epidural, & Caudal Blocks. In: Morgan and Mikhail's clinical anesthesiology. 5th ed. McGraw-Hill; 2013. p. 937-74

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Responsible Party: Dita Aditianingsih, Principal investigator, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03771339     History of Changes
Other Study ID Numbers: IndonesiaUAnes030
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dita Aditianingsih, Indonesia University:
quadratus lumborum block
continuous epidural
postoperative analgesia
kidney transplant

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents