Dual Approach External Oblique Fascial Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Percutaneous Nephrolithotomy (BLOCK-PCNL)

January 14, 2026 updated by: Amira S kenawy ,md, Zagazig University

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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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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  • **Detailed Description**

This prospective, randomized, double-blind controlled clinical study is designed to compare the postoperative analgesic efficacy of two ultrasound-guided regional anesthesia techniques-the dual-approach external oblique fascial plane block and the erector spinae plane block-in adult patients undergoing percutaneous nephrolithotomy (PCNL).

Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II, scheduled for unilateral PCNL under general anesthesia, will be enrolled after obtaining written informed consent. Participants will be randomly allocated in a 1:1:1 ratio into three groups: one group receiving the dual-approach external oblique fascial plane block, a second group receiving the erector spinae plane block, and a control group receiving general anesthesia alone according to the institutional standard analgesic protocol. Randomization will be performed using a computer-generated sequence, with allocation concealment ensured by sealed opaque envelopes. Outcome assessors and data analysts will be blinded to group allocation.

All patients will receive standardized general anesthesia. The regional blocks, when assigned, will be performed under ultrasound guidance using local anesthetic within safe dosage limits, following aseptic precautions. The dual-approach external oblique fascial plane block will involve injections at both the lateral abdominal wall and costal margin, while the erector spinae plane block will be performed at the thoracic paraspinal level. No regional anesthesia technique will be administered to patients in the control group.

Postoperative pain will be evaluated using the visual analog scale (VAS) at predefined time points during the first 24 hours after surgery. The primary outcome measure is postoperative pain intensity as assessed by VAS. Secondary outcome measures include total opioid (nalbuphine) consumption during the first 24 hours, intraoperative nociceptive responses as reflected by changes in heart rate and mean arterial pressure, patient satisfaction with pain management, and the incidence of block-related or anesthesia-related complications.

Rescue analgesia will be administered according to a predefined protocol when pain scores exceed the accepted threshold. All adverse events and complications related to the regional anesthesia techniques or general anesthesia will be monitored and documented throughout the intraoperative and postoperative periods.

The findings of this study are expected to clarify the relative effectiveness and safety of these two interfascial plane blocks for postoperative pain management following PCNL and may help guide clinical practice in regional anesthesia for urologic surgery.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:Refusal to participate

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm Name: Dual External Oblique Fascial Plane Block Arm Type: 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
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.
Experimental: Erector Spinae Plane Block
Participants receive ultrasound-guided erector spinae plane block in addition to standard general anesthesia for percutaneous nephrolithotomy.
Procedure: Erector Spinae Plane Block
Ultrasound-guided erector spinae plane block performed with local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy.
Active Comparator: General Anesthesia Only
articipants receive routine general anesthesia according to institutional standard analgesic protocol without the addition of any regional anesthesia technique.
Procedure: General Anesthesia
Routine general anesthesia according to institutional standard anesthetic and analgesic protocol without the addition of any regional anesthesia technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: First 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU_IRB# 1985 /13-Jan-2026 (Other Identifier: Faculty of Medicine, Zagazig University, Egypt)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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