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NCT Number: NCT03771339

Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery

Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

Epidural analgesia is the main choice of analgesia following kidney transplant surgery. However, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum (QL) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of QL block techniques for patients who underwent kidney transplant surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing elective kidney transplant laparotomy surgery
  • Agrees to participate in research
  • BMI < 30 kg/m2

Exclusion criteria

  • Declines to participate in research
  • Contraindications to intervention procedures (epidural or quadratus lumborum block)
  • History of local anaesthetic allergy
  • Systemic allergic reactions, anaphylactic reaction, cardiac arrest
  • Failure of intervention procedures (epidural or quadratus lumborum block)
  • Intraoperative complications (massive bleeding, hypotension)

Treatment and study plan

Continuous Epidural Analgesia

Procedure

Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy

Bilateral Quadratus Lumborum Block

Procedure

Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours

    Additional analgesia required at 2, 6, 12, and 24 hours after surgery

Secondary outcomes

  1. Pain Intensity

    Time frame: 24 hours

    Pain intensity measured using the Visual Analogue Scale (VAS) at 2, 6, 12, and 24 hours after surgery. VAS assessed with horizontal line 0-100 mm for no pain to the worst pain, with range 0-30 mm for none to mild pain, 31-70 mm for moderate pain, 71-100 mm for severe pain.

  2. First time morphine required

    Time frame: 24 hours

    Total time gap from postoperative analgesia procedure administration to first morphine requirement

  3. Total minimum and maximum dose of vasoactive agents

    Time frame: 24 hours

    Minimum and maximum dose of norepinephrine and dobutamine as vasoactive agents within 24 hours after surgery

  4. Urine output

    Time frame: 24 hours

    Urine output (mL/kgBW/hour) after surgery

  5. Bromage score

    Time frame: 24 hours

    Bromage score at 2, 6, 12, and 24 hours after surgery to assess lower limb motoric block.

    Score for Bromage:

    • free movement
    • partial block
    • almost complete
    • complete block

  6. Ramsay score

    Time frame: 24 hours

    Ramsay score at 2, 6, 12, and 24 hours after surgery to assess patient sedation level.

  7. Dermatomal coverage of analgesia procedure

    Time frame: Immediately after anaesthesia completion

    dermatome sensory block distribution using cold sensation test

  8. Blood ropivacaine level

    Time frame: 24 hours

    Arterial blood sample of all subjects will be withdrawn approximately 3 mL from the arterial line at 0, 30, 45, 60 minute, and 2, 4, 6,12,18, 24 hours after designated analgesia procedure, and will be used for ropivacaine blood level measurements using High-Performance Liquid Chromatography (HPLC), to measure Total plasma ropivacaine concentration (Cstop), maximum plasma concentration (Cmax), time of maximum plasma concentration, area under the curve (AUC)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Quadratus Lumborum Block and Epidural Analgesia for Postoperative Pain Management After Renal Transplantation

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Oct 28, 2020

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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