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Completed

NCT Number: NCT03520205

Quadratus Lumborum Block Versus Epidural for 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

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Key information

Conditions

Renal Transplant Donor of Left Kidney Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quadratus lumborum block

Procedure

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

Continuous Epidural

Procedure

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.

Primary outcomes

  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

  2. 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

Secondary outcomes

  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

    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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Time to first morphine requirement

    Time frame: 24 hours

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

  10. Total bupivacaine used in 24 hours

    Time frame: 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

    Time frame: 2, 6, 12, and 24 hours after procedure

    Measured by Bromage score

  12. Number of participants with paresthesia after procedure

    Time frame: 24 hours

    in percentage

  13. Duration of urinary catheter

    Time frame: 24 hours

    in hours

  14. Level of sensory block after procedure

    Time frame: 24 hours

    Measured by cold and pin prick sensation

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 9, 2018
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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