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
Verified date | October 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Central National Hospital | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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
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 ICONĀ® 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06197620 -
Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point Combined With Standard Therapy After Laparoscopic Living Donor Nephrectomy
|
N/A | |
Completed |
NCT02838134 -
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
|
Phase 4 | |
Active, not recruiting |
NCT02811835 -
TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)
|
N/A | |
Terminated |
NCT06458842 -
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy
|
N/A | |
Completed |
NCT04810884 -
Fractures and Bone Disease in Living Kidney Donors
|
||
Completed |
NCT01925677 -
Robotic Single Port Donor Nephrectomy
|
N/A | |
Completed |
NCT02699489 -
Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy
|
Phase 3 | |
Completed |
NCT03353298 -
Lowering Uric Acid in Live Kidney Donors
|
Phase 2 |