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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Continuous Epidural analgesia

Bilateral Quadratus Lumborum block

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring quadratus lumborum block, continuous epidural, postoperative analgesia, kidney transplant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Rumah Sakit Cipto Mangunkusumo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Epidural Analgesia

Bilateral Quadratus Lumborum Block

Arm Description

Continuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours

Bilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery

Outcomes

Primary Outcome Measures

Morphine consumption

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

Secondary Outcome Measures

Pain Intensity

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.

First time morphine required

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

Total minimum and maximum dose of vasoactive agents

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

Urine output

Urine output (mL/kgBW/hour) after surgery

Bromage score

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

Ramsay score

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

Dermatomal coverage of analgesia procedure

dermatome sensory block distribution using cold sensation test

Blood ropivacaine level

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)

Full Information

NCT ID

NCT03771339

First Posted

December 6, 2018

Last Updated

October 26, 2020

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT03771339

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

January 31, 2020 (Actual)

Study Completion Date

January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

quadratus lumborum block, continuous epidural, postoperative analgesia, kidney transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Epidural Analgesia

Arm Type

Active Comparator

Arm Description

Continuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours

Arm Title

Bilateral Quadratus Lumborum Block

Arm Type

Experimental

Arm Description

Bilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery

Intervention Type

Procedure

Intervention Name(s)

Continuous Epidural analgesia

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Bilateral Quadratus Lumborum block

Intervention Description

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

Primary Outcome Measure Information:

Title

Morphine consumption

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Pain Intensity

Description

Time Frame

24 hours

Title

First time morphine required

Description

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

Time Frame

24 hours

Title

Total minimum and maximum dose of vasoactive agents

Description

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

Time Frame

24 hours

Title

Urine output

Description

Urine output (mL/kgBW/hour) after surgery

Time Frame

24 hours

Title

Bromage score

Description

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

Time Frame

24 hours

Title

Ramsay score

Description

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

Time Frame

24 hours

Title

Dermatomal coverage of analgesia procedure

Description

dermatome sensory block distribution using cold sensation test

Time Frame

Immediately after anaesthesia completion

Title

Blood ropivacaine level

Description

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dita Aditianingsih, M.D.

Organizational Affiliation

Indonesia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rumah Sakit Cipto Mangunkusumo

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

Citation

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

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