NCT07059455

Brief Summary

Perioperative anesthesia and pain management are among the difficult situations for anesthesiologists to manage in kidney transplant patients. These patients are often complicated by comorbidities related to chronic kidney disease. The main issues in postoperative pain management for kidney transplant patients include dose adjustment, prevention of further renal damage, and maintenance of graft perfusion. Pain management in patients with end-stage renal disease may be inadequate due to limited options of systemic analgesics. In addition, regional analgesia techniques can be considered to avoid the adverse effects of anesthetics and systemic analgesics (1). Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of applications including thoracic, lumbar, and thoracic and abdominal surgeries (2,3). Transmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery (4). This study aims to evaluate the analgesic efficacy of ESPB and TMQLB in terms of pain management after kidney transplantation. The primary aim of the study was to evaluate pain scores and analgesic consumption between groups in the 24-hour postoperative period. The secondary aim was to evaluate the time to first analgesic requirement after block, the number of patients requiring analgesics, and the levels of nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 16, 2026

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 23, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

erectör spiane blockQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • evaluate pain scores and analgesic consumption between groups

    Patients' pain levels will be measured at 0, 1, 2, 6, 12, and 24 hours using a 10-point VAS. No pain will be assessed as 0 points, and severe pain will be assessed as 10 points.

    postoperative 24 hours

Study Arms (2)

erectör spinae plane block

ACTIVE COMPARATOR

Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of use in thoracic, lumbar, and thoracic and abdominal surgeries

Other: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Transmuskuler quadratus lumborum block

ACTIVE COMPARATOR

Transmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery

Other: Quadratus Lumborum (QL) Block

Interventions

Under general anesthesia, patients in the ESP group will be positioned in the left or right lateral decubitus position, depending on the side of the surgical procedure. After the T10 spinous process is identified by manual examination, sterile conditions will be established. The transverse process and erector spinae muscles will be visualized using an ultrasound probe. Using an in-plane technique, 20 ml of 0.25% bupivacaine will be injected between the transverse process and erector spinae muscles using a 22-gauge blocking needle.

erectör spinae plane block

Following standard anesthesia monitoring, patients will be placed in the lateral decubitus position. After the field is sterilized, a 2-5 MHz convex ultrasound probe (Samsung, HM70 EVO) will be placed between the iliac crest and costal arch at the level of the posterior axillary line. The transverse process of the L4 vertebra, erector spinae, QL, and PM muscles will be visualized. After inducing local anesthesia with 2% lidocaine (2 ml), a blocking needle (22G\*100 mm, Braun) will be advanced from posterolateral to anteromedial, inserting it between the QL and PM muscles, and 20 ml of 0.25% bupivacaine will be injected.

Transmuskuler quadratus lumborum block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplantation
  • Patients between the ages of 18-65

You may not qualify if:

  • Patients who do not agree to participate in the study,
  • Patients havecoagulopathy, liver function problems, local anesthetic allergy
  • Body mass index (BMI) \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Kartal, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

ParapsychologyDental OcclusionBupivacaine

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCİATED PROFESSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 10, 2025

Study Start

March 25, 2025

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

January 16, 2026

Record last verified: 2025-06

Locations