Clinical trial NCT06011850: Investigation of the Effects of Quadratus Lumborum Block Applied to Patients in Kidney Transplant Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Recipient
Kidney Transplant Donor
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Being a kidney recipient and donor in an organ transplant program

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of pain (NRS) level
timeFrame: postoperative 1st, 2nd, 6th, 12th, 24th hours
Secondary outcomes:
measure: Sedation- agitation level
timeFrame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
measure: Duration of first analgesic requirement
timeFrame: During the 24 hours postoperative period
measure: Blood pressure measurement
timeFrame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
measure: Measurement of heart rate
timeFrame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
measure: Amount of fentanyl consumed during the operation
timeFrame: During surgery
measure: Patient satisfaction assessment
timeFrame: At the end of 24 hours postoperatively
measure: Nausea-vomiting
timeFrame: During the 24 hours postoperative period
measure: Length of hospital stay
timeFrame: 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
measure: Total postoperative tramadol consumption
timeFrame: Within 24 hours postoperatively
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Fatma Acil, M.D.
role: STUDY_CHAIR
References:
citation: 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.