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

S

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status

Completed

Conditions

Kidney Transplant Donor
Kidney Transplant Recipient

Study type

Observational

Funder types

Other

Identifiers

NCT06011850
08.04.2023/484

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

94 participants in 4 patient groups

Kidney Donor QLB Group
Description:
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
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Fatma Acil, M.D.

Data sourced from clinicaltrials.gov

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