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Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03520205
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Aida Rosita Tantri, Indonesia University

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
Renal Transplant Donor of Left Kidney Procedure: Quadratus Lumborum Block Procedure: Epidural Not Applicable

Detailed Description:
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. 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. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. On epidural group, epidural catheter was inserted (4-6cm depth inside the epidural space) with 1-2 mg IV midazolam as premedication. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given 6 cc of marcain 0.25% and continued epidural with the rate of 6 cc/hour. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Maintenance was done by sevofluran, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed stimuplex 100cc needle with 20 cc of bupivicain 0.25% as regimen. Blood sampel was redrawn 2 hours after abdominal insufflation. Patient were extubated until fully consious and can follow command verbally. Patient will be transported in recovery room post operation. NRS and morphine consumption were measured at 2, 6, 12, and 24 hours after procedure.

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Study Type : Interventional  (Clinical Trial)
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 : August 30, 2018
Actual Study Completion Date : December 31, 2018

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 on patient using stimuplex 100cc needle with 20 cc of bupivicain 0.25% as regimen.

Active Comparator: Epidural
Patient will receive epidural anesthesia
Procedure: Epidural
Patient will be given 6 cc of marcain 0.25% and continued epidural with the rate of 6 cc/hour.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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

  3. 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

  4. Change from Baseline Blood pressure at 5 minutes after procedure [ Time Frame: Before and 5 minute after procedure ]
    Measured by non-invasive blood pressure monitoring

  5. Change from Baseline Pulse at 5 minutes after procedure [ Time Frame: Before and 5 minutes after procedure ]
    Measured by pulse oximetry

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520205


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Additional Information:
Publications:

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Responsible Party: Aida Rosita Tantri, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03520205     History of Changes
Other Study ID Numbers: IndonesiaUAnes021
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aida Rosita Tantri, Indonesia University:
stress response
kidney donor
Cellular Imunological Function
quadratus lumborum block
numerical rating scale
morphine patient controlled analgesia