An observational study in Kidney Transplant Recipient and Kidney Transplant Donor, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational
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.
Plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area
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.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.
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Being a kidney recipient and donor in an organ transplant program
Exclusion Criteria:
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.
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.
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.
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.
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"
Time frame: postoperative 1st, 2nd, 6th, 12th, 24th hours
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
Time frame: 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
Time frame: During the 24 hours postoperative period
Blood pressure measurement
Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At the end of 24 hours postoperatively
Nausea-vomiting
Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
Time frame: During the 24 hours postoperative period
Length of hospital stay
Days of hospitalisation after the operation
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
Total postoperative tramadol consumption
milligrams
Time frame: Within 24 hours postoperatively
Plan to share: Undecided
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital