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

NCT ID: NCT06011850

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-03

Study Completion Date

2024-05-07

Brief Summary

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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

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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.

Conditions

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Kidney Transplant Recipient Kidney Transplant Donor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatma Acil,MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Acil, M.D.

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Locations

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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32792737 (View on PubMed)

Other Identifiers

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08.04.2023/484

Identifier Type: -

Identifier Source: org_study_id

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