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

NCT06011850 | Completed

• 1 other identifier: 08.04.2023/484
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Recipient; Kidney Transplant Donor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Sedation- agitation level

  Will be assessed from immediately after extubation until transfer from the recovery room to the ward.

• Duration of first analgesic requirement

  During the 24 hours postoperative period

• Blood pressure measurement

  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

  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

  During surgery

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Being a kidney recipient and donor in an organ transplant program

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related 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.

  PMID: 32792737 BACKGROUND

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 25, 2023
• Study Start: October 3, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 7, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

TU (1)