- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03520205
Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
October 21, 2019 updated by: Aida Rosita Tantri, Indonesia University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Central National Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quadratus Lumborum Block
Patient will receive 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
|
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
Time Frame: Before procedure, at the end of surgery, and 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
Time Frame: 2 hours, 6 hours, 12 hours, 24 hours.
|
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
Time Frame: 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
Time Frame: 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
Time Frame: Before procedure and 2 hours after abdominal insufflation
|
Measured by finger-stick blood sample
|
Before procedure and 2 hours after abdominal insufflation
|
Change from Baseline Blood pressure
Time Frame: Intraoperative and 24 hours
|
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
Time Frame: Intraoperative and 24 hours
|
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
Time Frame: Intraoperative and 24 hours
|
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
Time Frame: Intraoperative and 24 hours
|
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
Time Frame: Before procedure, at the end of surgery, and 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
Time Frame: 24 hours
|
Duration from end of anesthesia until first attempt of morphine requirement in minutes
|
24 hours
|
Total bupivacaine used in 24 hours
Time Frame: 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
Time Frame: 2, 6, 12, and 24 hours after procedure
|
Measured by Bromage score
|
2, 6, 12, and 24 hours after procedure
|
Number of participants with paresthesia after procedure
Time Frame: 24 hours
|
in percentage
|
24 hours
|
Duration of urinary catheter
Time Frame: 24 hours
|
in hours
|
24 hours
|
Level of sensory block after procedure
Time Frame: 24 hours
|
Measured by cold and pin prick sensation
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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