NCT07726550

Brief Summary

This prospective, randomized, assessor-blinded clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified External Oblique Intercostal Plane Block (EOIPB) in patients undergoing elective open nephrectomy under general anesthesia. Sixty adult patients will be randomized to receive either ESPB or EOIPB before surgical incision. All participants will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The study aims to determine whether one fascial plane block technique provides superior postoperative pain control and recovery following open nephrectomy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 22, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Erector Spinae Plane BlockExternal Oblique Intercostal Plane BlockRegional AnesthesiaEOIPBESPBPostoperative AnalgesiaOpen NephrectomyMultimodal AnalgesiaPain Management

Outcome Measures

Primary Outcomes (1)

  • Pain intensity at rest

    Postoperative pain intensity will be assessed at rest using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

    0, 2, 6, 12, and 24 hours after surgery

Secondary Outcomes (6)

  • Pain intensity during movement

    0, 2, 6, 12, and 24 hours after surgery

  • Total Opioid Consumption

    24 hours after surgery

  • Rescue Analgesic Requirement

    24 hours after surgery

  • Postoperative Nausea and Vomiting

    24 hours after surgery

  • Heart Rate

    From induction of anesthesia until the end of surgery

  • +1 more secondary outcomes

Study Arms (2)

ESPB Group

EXPERIMENTAL

Participants will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.

Procedure: Erector Spinae Plane Block

EOIPB Group

EXPERIMENTAL

Participants will receive an ultrasound-guided modified external oblique intercostal plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.

Procedure: Modified External Oblique Intercostal Plane Block

Interventions

Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.

EOIPB Group

Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.

ESPB Group

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for elective open nephrectomy.
  • Able and willing to provide written informed consent.
  • Willing to comply with study procedures.

You may not qualify if:

  • Refusal to participate or inability to provide informed consent.
  • Emergency surgery.
  • Body mass index (BMI) greater than 35 kg/m².
  • Known allergy or hypersensitivity to local anesthetics.
  • Infection at the planned block insertion site.
  • Coagulopathy or ongoing anticoagulant therapy.
  • Pregnancy or breastfeeding.
  • Prisoners or other vulnerable populations unable to provide independent consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namık Kemal University

Tekirdağ, Tekirdağ, 59000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of group allocation because all block procedures will be performed after induction of general anesthesia. Postoperative outcome assessments will be conducted by a researcher who is blinded to treatment allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided erector spinae plane block (ESPB) or modified external oblique intercostal plane block (EOIPB) before surgical incision. Both groups will receive standardized general anesthesia and postoperative multimodal analgesia.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data are not planned to be shared because no formal data-sharing infrastructure or approved data-sharing plan has been established for this study.

Locations