Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03520205
• Date of registration: 15/04/2018
• Prospective Registration: Yes
• Primary sponsor: Indonesia University
• Public title: Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
• Scientific title: Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
• Date of first enrolment: May 1, 2018
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03520205
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Indonesia

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Renal Transplant Donor of Left Kidney

Intervention(s)

Procedure: Quadratus Lumborum Block

Procedure: Continuous Epidural

Primary Outcome(s)

Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative [Time Frame: 2 hours, 6 hours, 12 hours, 24 hours.]

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]

Secondary Outcome(s)

Change from Baseline Mean Arterial Pressure [Time Frame: Intraoperative and 24 hours]

Number of participants with paresthesia after procedure [Time Frame: 24 hours]

Change from Baseline Blood pressure [Time Frame: Intraoperative and 24 hours]

Change from Baseline Cardiac Index [Time Frame: Intraoperative and 24 hours]

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]

Level of sensory block after procedure [Time Frame: 24 hours]

Total bupivacaine used in 24 hours [Time Frame: 24 hours]

Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure [Time Frame: 2, 6, 12, and 24 hours after procedure]

Time to first morphine requirement [Time Frame: 24 hours]

Change from Baseline Blood Glucose at 2 hours after abdominal insufflation [Time Frame: Before procedure and 2 hours after abdominal insufflation]

Change from Baseline Heart Rate [Time Frame: Intraoperative and 24 hours]

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]

Duration of urinary catheter [Time Frame: 24 hours]

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]

Secondary ID(s)

IndonesiaUAnes021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors