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NCT Number: NCT06011850

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

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.

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Key information

Conditions

Kidney Transplant Recipient Kidney Transplant Donor

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assessment of pain (NRS) level

    Time frame: postoperative 1st, 2nd, 6th, 12th, 24th hours

    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"

Secondary outcomes

  1. Sedation- agitation level

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

    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

  2. Duration of first analgesic requirement

    Time frame: During the 24 hours postoperative period

    Time in minutes from the patient's extubation to the first analgesic requirement

  3. Blood pressure measurement

    Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.

    Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.

  4. Measurement of heart rate

    Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.

    The number of heart beats per minute obtained by electrocardiographic monitoring

  5. Amount of fentanyl consumed during the operation

    Time frame: During surgery

    Micrograms of fentanyl consumed during surgery

  6. Patient satisfaction assessment

    Time frame: At the end of 24 hours postoperatively

    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.

  7. Nausea-vomiting

    Time frame: During the 24 hours postoperative period

    Questioning about the presence/absence of nausea and/or vomiting in the postoperative period

  8. Length of hospital stay

    Time frame: 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

    Days of hospitalisation after the operation

  9. Total postoperative tramadol consumption

    Time frame: Within 24 hours postoperatively

    milligrams

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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