Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

Renal Transplant Donor of Left Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520205
• Other study ID #: IndonesiaUAnes021
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Donor of Left Kidney

Intervention

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
• 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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (14)

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. — View Citation

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. Epub 2004 May 12. Review. — View Citation

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. — View Citation

Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206. Review. — View Citation

Øyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. — View Citation

SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. Review. — View Citation

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. Review. — View Citation

Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor(®)) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to first morphine requirement	Duration from end of anesthesia until first attempt of morphine requirement in minutes	24 hours
Secondary	Total bupivacaine used in 24 hours	Total bupivacaine used until 24 hours postoperatively	24 hours
Secondary	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
Secondary	Number of participants with paresthesia after procedure	in percentage	24 hours
Secondary	Duration of urinary catheter	in hours	24 hours
Secondary	Level of sensory block after procedure	Measured by cold and pin prick sensation	24 hours

External Links

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