Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Study Overview

• Status: Completed
• Conditions: Renal Transplant Donor of Left Kidney
• Intervention / Treatment: Procedure: Quadratus Lumborum Block; Procedure: Continuous Epidural

Detailed Description

Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Kidney donor patients undergoing laparoscopic nephrectomy
• Body mass index below 30
• Duration of surgery 4 to 6 hours
• Patients who agreed to participate in this study and sign informed consent.

Exclusion Criteria:

Have contraindication for quadratus lumborum block

• Have contraindication for epidural
• Previous history of local anesthetic drug allergy
• inability to communicate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum Block; Patient will receive quadratus lumborum block	Procedure: Quadratus Lumborum Block; Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia
Active Comparator: Continuous Epidural; Patient will receive epidural anesthesia	Procedure: Continuous Epidural; Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation	Measure by ELISA	Before procedure, at the end of surgery, and 24 hours after abdominal insufflation
Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative	Cumulative morphine consumption at each time point in 24 hours after surgery	2 hours, 6 hours, 12 hours, 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure	Measure by how many times patient use morphine PCA analgesia	2, 6, 12, and 24 hours after procedure
Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure	Measured by Numerical Rating Scale	2, 6, 12, and 24 hours after procedure
Change from Baseline Blood Glucose at 2 hours after abdominal insufflation	Measured by finger-stick blood sample	Before procedure and 2 hours after abdominal insufflation
Change from Baseline Blood pressure	Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery	Intraoperative and 24 hours
Change from Baseline Mean Arterial Pressure	Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery	Intraoperative and 24 hours
Change from Baseline Cardiac Index	Measured by cardiometry ICON® at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery	Intraoperative and 24 hours
Change from Baseline Heart Rate	Measured by pulse oximetry at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery	Intraoperative and 24 hours
Change from Baseline hs-CRP at 48 hours after abdominal insufflation	Measured with ELISA	Before procedure, at the end of surgery, and 48 hours after abdominal insufflation
Time to first morphine requirement	Duration from end of anesthesia until first attempt of morphine requirement in minutes	24 hours
Total bupivacaine used in 24 hours	Total bupivacaine used until 24 hours postoperatively	24 hours
Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery	Measured by Bromage score	2, 6, 12, and 24 hours after procedure
Number of participants with paresthesia after procedure	in percentage	24 hours
Duration of urinary catheter	in hours	24 hours
Level of sensory block after procedure	Measured by cold and pin prick sensation	24 hours

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
• Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
• SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.
• Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.
• Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.
• Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
• Das W, Bhattacharya S, Ghosh S, Saha S, Mallik S, Pal S. Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial. Saudi J Anaesth. 2015 Apr-Jun;9(2):184-8. doi: 10.4103/1658-354X.152881.
• Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.
• Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206.
• Oyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. doi: 10.1016/j.transproceed.2006.08.102.
• Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.
• Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.
• Spiro MD, Eilers H. Intraoperative care of the transplant patient. Anesthesiol Clin. 2013 Dec;31(4):705-21. doi: 10.1016/j.anclin.2013.09.005. Epub 2013 Nov 6.
• Bhosale G, Shah V. Combined spinal-epidural anesthesia for renal transplantation. Transplant Proc. 2008 May;40(4):1122-4. doi: 10.1016/j.transproceed.2008.03.027.
• Aditianingsih D, Pryambodho, Anasy N, Tantri AR, Mochtar CA. A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019 Dec 5;19(1):221. doi: 10.1186/s12871-019-0891-7.

Helpful Links

• STRESS RESPONSE AND ANAESTHESIA ALTERING THE PERI AND POST-OPERATIVE MANAGEMENT
• Efficacy of parecoxib on the level of IL-6, CRP, and postoperative pain relief after percutaneous nephrolithotomy

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 15, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: stress response; quadratus lumborum block; kidney donor; Cellular Imunological Function; numerical rating scale; morphine patient controlled analgesia
• Other Study ID Numbers: IndonesiaUAnes021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No