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

October 26, 2020 updated by: Dita Aditianingsih, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Epidural Analgesia
Continuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours
Procedure: Continuous Epidural analgesia
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
Experimental: Bilateral Quadratus Lumborum Block
Bilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery
Procedure: Bilateral Quadratus Lumborum block
Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 24 hours
Additional analgesia required at 2, 6, 12, and 24 hours after surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
First time morphine required
Time Frame: 24 hours
Total time gap from postoperative analgesia procedure administration to first morphine requirement
24 hours
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
24 hours
Urine output
Time Frame: 24 hours
Urine output (mL/kgBW/hour) after surgery
24 hours
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:

  1. free movement
  2. partial block
  3. almost complete
  4. complete block
24 hours
Ramsay score
Time Frame: 24 hours
Ramsay score at 2, 6, 12, and 24 hours after surgery to assess patient sedation level.
24 hours
Dermatomal coverage of analgesia procedure
Time Frame: Immediately after anaesthesia completion
dermatome sensory block distribution using cold sensation test
Immediately after anaesthesia completion
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)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Dita Aditianingsih, M.D., Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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