Clinical trial NCT03520205: Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
Official title: Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation
timeFrame: Before procedure, at the end of surgery, and 24 hours after abdominal insufflation
measure: Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative
timeFrame: 2 hours, 6 hours, 12 hours, 24 hours.
Secondary outcomes:
measure: Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure
timeFrame: 2, 6, 12, and 24 hours after procedure
measure: Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure
timeFrame: 2, 6, 12, and 24 hours after procedure
measure: Change from Baseline Blood Glucose at 2 hours after abdominal insufflation
timeFrame: Before procedure and 2 hours after abdominal insufflation
measure: Change from Baseline Blood pressure
timeFrame: Intraoperative and 24 hours
measure: Change from Baseline Mean Arterial Pressure
timeFrame: Intraoperative and 24 hours
measure: Change from Baseline Cardiac Index
timeFrame: Intraoperative and 24 hours
measure: Change from Baseline Heart Rate
timeFrame: Intraoperative and 24 hours
measure: Change from Baseline hs-CRP at 48 hours after abdominal insufflation
timeFrame: Before procedure, at the end of surgery, and 48 hours after abdominal insufflation
measure: Time to first morphine requirement
timeFrame: 24 hours
measure: Total bupivacaine used in 24 hours
timeFrame: 24 hours
measure: Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery
timeFrame: 2, 6, 12, and 24 hours after procedure
measure: Number of participants with paresthesia after procedure
timeFrame: 24 hours
measure: Duration of urinary catheter
timeFrame: 24 hours
measure: Level of sensory block after procedure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
References:
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