Investigation of the Effects of Quadratus Lumborum Block Applied to Patients in Kidney Transplant Surgery

Comparison of the Effects of Quadratus Lumborum Block (QLB) Applied for Preemptive Analgesia on Post-operative Pain in Recipients and Donors in Renal Transplantation Surgery With Intravenous Analgesic (IVA) Group

This study aims to determine the most effective and long-lasting pain relief method for post-operative analgesia in kidney donor and recipient patients in kidney transplantation programme with the least invasive and least drug administration.

For this reason, it is planned to perform Quadratus lumborum plane block (QLB) in a group of patients who will be kidney donors and kidney recipients in kidney transplantation and who meet the American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3 risk classification between the ages of 18-70 years, and to administer intravenous pain medication without block in another group. It is planned to include at least 84 patients in the Quadratus lumborum plan block (QLB) and Intravenous Analgesia group (IVA) without gender discrimination.

Postoperative Sedation-Agitation assessment and NRS (numeric pain scale) at 1st hour, 2nd, 6th, 12th and 24th hours, as well as possible side effects such as nausea, vomiting, shoulder pain, respiratory depression, bradycardia and hypotension, total amount of opioid analgesics consumed within 24 hours and duration of hospital stay will be observed and recorded.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Recipient; Kidney Transplant Donor

Detailed Description

Plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area

• the injection will be administered immediately after general anaesthesia and intubation of the patient
• to monitor compliance with the intervention The medical files and laboratory blood tests of the patients will be examined to determine whether there are any contraindications to the intervention (patients will be excluded in case of bleeding diathesis such as intra-abdominal fluid accumulation, cystic formation, International Normalized Ratio (INR) > 2 or thrombocytopenia).

Blood pressure and heart rate values of the patient and the amount of fentanyl consumed will be recorded throughout the surgery.

The level of sedation-agitation will be evaluated during extubation at the end of surgery.

In the postoperative period, blood pressure, heart rate, pain scoring and the amount of opioid analgesic consumed will be recorded by the anaesthesiologist in the general surgery organ transplant unit and the general surgery specialist and nurses in the organ transplant service at the 1st, 2nd, 6th, 12th, and 24th hours.

The patient's satisfaction level will be evaluated and recorded 24 hours after the operation.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Turkey
  • Diyarbakır, Turkey, 21070
    • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Being a kidney recipient and donor in an organ transplant program

Description

Inclusion Criteria:

• Patients aged 18-70 years,
• American Society of Anesthesiologists (ASA) Physical Status Classification System I-III,
• Being a volunteer kidney recipient or volunteer donor in a kidney transplant programme under general anaesthesia

Exclusion Criteria:

• Age <18 years or > 70 years
• American Society of Anesthesiologists (ASA) Physical Status Classification System >III
• body mass index (BMI) > 35 kg/m2
• known allergy to local anaesthetics or paracetamol/tramadol
• presence of preoperative chronic pain
• presence of accumulated fluid or cystic formation in the abdomen
• presence of coagulopathy
• those who are unable to give written consent

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Kidney Donor QLB Group; Quadratus lumborum block (QLB) will be applied to the kidney donor in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.
Kidney Donor Paracetamol Group; In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney donor before the surgical incision is started, immediately after induction of general anesthesia.
Kidney Recipient QLB Group; Quadratus lumborum block (QLB) will be applied to the kidney recipient in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.
Kidney Recipient Paracetamol Group; In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney recipient before the surgical incision is started, immediately after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain (NRS) level	The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"	postoperative 1st, 2nd, 6th, 12th, 24th hours
Total postoperative tramadol consumption	milligrams	Within 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation- agitation level	The Riker Sedation- Agitation Scale (RSAS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior. Riker sedation-agitation Scale:1- Unarousable, 2 -Very Sedated, 3- Sedated, 4 Calm and Cooperative, 5 -Agitated, 6 -Very Agitated, 7 -Dangerous Agitation	Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
Duration of first analgesic requirement	Time in minutes from the patient's extubation to the first analgesic requirement	During the 24 hours postoperative period
Blood pressure measurement	Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.	It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Measurement of heart rate	The number of heart beats per minute obtained by electrocardiographic monitoring	It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Amount of fentanyl consumed during the operation	Micrograms of fentanyl consumed during surgery	During surgery
Patient satisfaction assessment	Patients' satisfaction with the quality of pain management will be assessed at 24 hours postoperatively using the following scale: 1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfied; 5 = very satisfied.	At the end of 24 hours postoperatively
Nausea-vomiting	Questioning about the presence/absence of nausea and/or vomiting in the postoperative period	During the 24 hours postoperative period
Length of hospital stay	Days of hospitalisation after the operation	It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

General Publications

• Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth. 2020 Jul;64(7):605-610. doi: 10.4103/ija.IJA_21_20. Epub 2020 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): May 6, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 08.04.2023/484

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