NCT07071012

Brief Summary

This study aims to compare the effects of external oblique intercostal block versus paravertebral block on postoperative pain and complications in patients undergoing open nephrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

July 6, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

July 6, 2025

Last Update Submit

March 15, 2026

Conditions

NephrectomyPain ScoresParavertebral BlockExternal Oblique Intercostal Block

Keywords

postoperative painnephrectomyExternal oblique intercostal blockparavertebral block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score

    Pain intensity measured using Visual Analog Scale at rest. (Visual Analog Scale ranging from 0 = no pain to 10 = worst pain imaginable; higher scores indicate worse pain).

    Up to 24 hours after surgery

Study Arms (2)

Paravertebral block

ACTIVE COMPARATOR

Patients scheduled to undergo thoracic paravertebral block will receive an injection of 20 ml of 0.25% bupivacaine hydrochloride into the paravertebral space between the parietal pleura and the costotransverse ligament using a block needle under ultrasound guidance.

Drug: BupivacaineDrug: morphineDrug: paracetamolDrug: Diclofenac

External Oblique Intercostal Block

ACTIVE COMPARATOR

Patients scheduled to undergo an external oblique intercostal block will receive an injection of 30 ml of 0.25% bupivacaine hydrochloride between the external oblique muscle and the intercostal muscle at the level of the 6th rib, using a block needle under ultrasound guidance.

Drug: BupivacaineDrug: morphineDrug: paracetamolDrug: Diclofenac

Interventions

BupivacaineDRUG

Used for regional anesthesia during nephrectomy procedure (e.g., paravertebral or external oblique intercostal block)

External Oblique Intercostal BlockParavertebral block
morphineDRUG

Used for postoperative pain control via PCA device

External Oblique Intercostal BlockParavertebral block
paracetamolDRUG

Used as part of postoperative multimodal analgesia

External Oblique Intercostal BlockParavertebral block
DiclofenacDRUG

Used as part of postoperative multimodal analgesia

External Oblique Intercostal BlockParavertebral block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 90 years
  • Scheduled for elective open radical nephrectomy for renal cell carcinoma
  • ASA classification I-III
  • Mini-Mental State Examination score ≥24
  • Provided written informed consent

You may not qualify if:

  • Neuropathy
  • Hepatic failure
  • Coagulopathy
  • Local anesthetic allergy
  • Mini-Mental State Examination score \<24
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Medicine Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineMorphineAcetaminophenDiclofenac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

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

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 17, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 2, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)