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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771339
• Other study ID #: IndonesiaUAnes030
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Additional analgesia required at 2, 6, 12, and 24 hours after surgery	24 hours
Secondary	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.	24 hours
Secondary	First time morphine required	Total time gap from postoperative analgesia procedure administration to first morphine requirement	24 hours
Secondary	Total minimum and maximum dose of vasoactive agents	Minimum and maximum dose of norepinephrine and dobutamine as vasoactive agents within 24 hours after surgery	24 hours
Secondary	Urine output	Urine output (mL/kgBW/hour) after surgery	24 hours
Secondary	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	24 hours
Secondary	Ramsay score	Ramsay score at 2, 6, 12, and 24 hours after surgery to assess patient sedation level.	24 hours
Secondary	Dermatomal coverage of analgesia procedure	dermatome sensory block distribution using cold sensation test	Immediately after anaesthesia completion
Secondary	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)	24 hours