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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03520205
Enrollment
62
Registered
2018-05-09
Start date
2018-05-01
Completion date
2018-12-31
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant Donor of Left Kidney

Keywords

stress response, kidney donor, Cellular Imunological Function, quadratus lumborum block, numerical rating scale, morphine patient controlled analgesia

Brief summary

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

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.

Interventions

PROCEDUREQuadratus 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

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.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflationBefore procedure, at the end of surgery, and 24 hours after abdominal insufflationMeasure by ELISA
Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative2 hours, 6 hours, 12 hours, 24 hours.Cumulative morphine consumption at each time point in 24 hours after surgery

Secondary

MeasureTime frameDescription
Change from Baseline Blood Glucose at 2 hours after abdominal insufflationBefore procedure and 2 hours after abdominal insufflationMeasured by finger-stick blood sample
Change from Baseline Blood pressureIntraoperative and 24 hoursMeasured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Change from Baseline Mean Arterial PressureIntraoperative and 24 hoursMeasured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Change from Baseline Cardiac IndexIntraoperative and 24 hoursMeasured by cardiometry ICON® at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Change from Baseline Heart RateIntraoperative and 24 hoursMeasured by pulse oximetry at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Change from Baseline hs-CRP at 48 hours after abdominal insufflationBefore procedure, at the end of surgery, and 48 hours after abdominal insufflationMeasured with ELISA
Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure2, 6, 12, and 24 hours after procedureMeasure by how many times patient use morphine PCA analgesia
Total bupivacaine used in 24 hours24 hoursTotal bupivacaine used until 24 hours postoperatively
Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery2, 6, 12, and 24 hours after procedureMeasured by Bromage score
Number of participants with paresthesia after procedure24 hoursin percentage
Duration of urinary catheter24 hoursin hours
Level of sensory block after procedure24 hoursMeasured by cold and pin prick sensation
Time to first morphine requirement24 hoursDuration from end of anesthesia until first attempt of morphine requirement in minutes
Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure2, 6, 12, and 24 hours after procedureMeasured by Numerical Rating Scale

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026