NCT07359391

Brief Summary

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  • \*\*Brief Summary\*\* Percutaneous nephrolithotomy (PCNL) is a common surgical procedure used to remove large kidney stones. Patients often experience moderate to severe pain after this surgery due to the surgical incision and irritation of the kidney and surrounding tissues. Effective pain control after PCNL is important to improve patient comfort, reduce the need for opioid medications, and enhance recovery. Several regional anesthesia techniques have been developed to reduce postoperative pain. Two of these techniques are the dual-approach external oblique fascial plane block and the erector spinae plane block. Both techniques involve injecting a local anesthetic near specific muscle planes using ultrasound guidance to reduce pain signals from the surgical area. However, it is not yet clear which of these two techniques provides better pain relief after PCNL. This study aims to compare the effectiveness of the dual-approach external oblique fascial plane block and the erector spinae plane block in controlling pain after PCNL surgery. Adult patients scheduled for PCNL will be randomly assigned to receive one of the two nerve block techniques or standard general anesthesia alone. Pain levels, additional pain medication requirements, patient satisfaction, and any block-related complications will be assessed during the first 24 hours after surgery. The results of this study may help determine the most effective regional anesthesia technique for improving postoperative pain management in patients undergoing PCNL.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress58%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 12, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

Percutaneous NephrolithotomyPostoperative AnalgesiaDual Approach External Oblique Fascial Plane BlockErector Spinae Plane BlockPain Management

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    Postoperative pain will be assessed using the Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain, measured at predefined time points during the first 24 hours after surgery.

    First 24 hours postoperatively

Study Arms (3)

Arm Name: Dual External Oblique Fascial Plane Block Arm Type: Experimental

EXPERIMENTAL

Participants receive ultrasound-guided dual-approach (lateral and costal) external oblique fascial plane block in addition to standard general anesthesia for percutaneous nephrolithotomy.

Procedure: Dual External Oblique Fascial Plane Block

Erector Spinae Plane Block

EXPERIMENTAL

Participants receive ultrasound-guided erector spinae plane block in addition to standard general anesthesia for percutaneous nephrolithotomy.

Procedure: Erector Spinae Plane Block

General Anesthesia Only

ACTIVE COMPARATOR

articipants receive routine general anesthesia according to institutional standard analgesic protocol without the addition of any regional anesthesia technique.

Procedure: General Anesthesia

Interventions

Ultrasound-guided erector spinae plane block performed with local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy.

Erector Spinae Plane Block

Ultrasound-guided dual-approach (lateral and costal) external oblique fascial plane block performed using local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy.

Arm Name: Dual External Oblique Fascial Plane Block Arm Type: Experimental

Routine general anesthesia according to institutional standard anesthetic and analgesic protocol without the addition of any regional anesthesia technique.

General Anesthesia Only

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
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Scheduled for unilateral percutaneous nephrolithotomy (PCNL)
  • Ability to understand the study protocol and provide written informed conse

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics
  • Infection at the site of block injection
  • Coagulopathy or bleeding disorders
  • Chronic pain syndrome or long-term opioid use
  • Severe hepatic, renal, or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney CalculiAgnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and postoperative outcome assessors are blinded to group allocation. Randomization is performed using sealed opaque envelopes opened by an anesthesiologist not involved in postoperative assessment. The anesthesiologist performing the block is not blinded due to the nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Intensive Care, and Pain Management

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01