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

Kidney Transplant Recipient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011850
• Other study ID #: 08.04.2023/484
• Status: Completed
• Start date: October 3, 2023
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 7, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Donor
• Kidney Transplant Recipient

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total postoperative tramadol consumption	milligrams	Within 24 hours postoperatively
Secondary	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.
Secondary	Duration of first analgesic requirement	Time in minutes from the patient's extubation to the first analgesic requirement	During the 24 hours postoperative period
Secondary	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.
Secondary	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.
Secondary	Amount of fentanyl consumed during the operation	Micrograms of fentanyl consumed during surgery	During surgery
Secondary	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
Secondary	Nausea-vomiting	Questioning about the presence/absence of nausea and/or vomiting in the postoperative period	During the 24 hours postoperative period
Secondary	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