NCT07369323

Brief Summary

Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on dialysis are hepatitis C or hepatitis B virus positive, and the use of other effective analgesics, such as acetaminophen, is limited.The use of regional analgesia methods for postoperative analgesia can also be a useful option for more adequate control in these patients. Currently, methods of fascial trunk nerve blocks (including rectus sheath block, different types of transversus abdominis plane block, and erector spinae plane \[ESP\] block) have been shown to be effective components of multimodal anesthesia in various fields of surgery.In this study, investigators evaluated the effectiveness of ESP block in the postoperative period after kidney transplant.The aim of this prospective, randomized controlled trial is to evaluate the effects of erector spinae plane block on postoperative analgesia quality, opioid consumption, and side effect profile in kidney transplant patients.The study included a total of 40 patients aged 18-65 years with ASA physical status II-III who were scheduled for elective kidney transplantation. All patients received standard general anesthesia. Anesthesia induction was achieved with propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg). Anesthesia maintenance was provided with 6% desflurane and a 50% oxygen-air mixture.ESPB Group: USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)

  • Control Group: no block applied
  • All patients received standard postoperative analgesia protocol. Intravenous paracetamol (1 g/8 hours) was given. Intravenous tramadol (100 mg) was administered as rescue analgesic when VAS ≥ 4.

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 Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 25, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

renal transplantationerector spine plane blockpain management

Outcome Measures

Primary Outcomes (1)

  • Postoperrative VAS scores at 24 hours

    Postoperative Vas scores at 15 minutes, 1 hour, 2 hours, 6 hours, 12 hours, and 24 hours

    postoperative 24 hours

Study Arms (1)

Control group

OTHER

tandard postoperative analgesia protocol was applied. Intravenous paracetamol (1 g/8 hours) was administered. ESP block not implemented

Other: ESP block

Interventions

USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)

Control group

Eligibility Criteria

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

You may qualify if:

  • All patients had end-stage renal disease due to chronic glomerulonephritis \_ physical status of class 3 on American Society of Anesthesiologists classification.

You may not qualify if:

  • ASA 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lutfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal InsufficiencyAgnosia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assosiate proffesor

Study Record Dates

First Submitted

May 25, 2025

First Posted

January 27, 2026

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

May 1, 2025

Last Updated

January 27, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations