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Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT03520205
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Quadratus Lumborum Block
  • Procedure: Continuous Epidural
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Quadratus Lumborum Block

Patient will receive quadratus lumborum block

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
Active Comparator: Continuous Epidural

Patient will receive epidural anesthesia

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation [Before procedure, at the end of surgery, and 24 hours after abdominal insufflation]

    Measure by ELISA

  2. Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative [2 hours, 6 hours, 12 hours, 24 hours.]

    Cumulative morphine consumption at each time point in 24 hours after surgery

Secondary Outcome Measures

  1. Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure [2, 6, 12, and 24 hours after procedure]

    Measure by how many times patient use morphine PCA analgesia

  2. Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure [2, 6, 12, and 24 hours after procedure]

    Measured by Numerical Rating Scale

  3. Change from Baseline Blood Glucose at 2 hours after abdominal insufflation [Before procedure and 2 hours after abdominal insufflation]

    Measured by finger-stick blood sample

  4. Change from Baseline Blood pressure [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

  5. Change from Baseline Mean Arterial Pressure [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

  6. Change from Baseline Cardiac Index [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

  7. Change from Baseline Heart Rate [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

  8. Change from Baseline hs-CRP at 48 hours after abdominal insufflation [Before procedure, at the end of surgery, and 48 hours after abdominal insufflation]

    Measured with ELISA

  9. Time to first morphine requirement [24 hours]

    Duration from end of anesthesia until first attempt of morphine requirement in minutes

  10. Total bupivacaine used in 24 hours [24 hours]

    Total bupivacaine used until 24 hours postoperatively

  11. Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery [2, 6, 12, and 24 hours after procedure]

    Measured by Bromage score

  12. Number of participants with paresthesia after procedure [24 hours]

    in percentage

  13. Duration of urinary catheter [24 hours]

    in hours

  14. Level of sensory block after procedure [24 hours]

    Measured by cold and pin prick sensation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Aida Rosita Tantri, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier:
NCT03520205
Other Study ID Numbers:
  • IndonesiaUAnes021
First Posted:
May 9, 2018
Last Update Posted:
Oct 22, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aida Rosita Tantri, Anesthesiologist Consultant, Indonesia University
stress response
kidney donor
Cellular Imunological Function
quadratus lumborum block
numerical rating scale
morphine patient controlled analgesia

Study Results

No Results Posted as of Oct 22, 2019