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NCT Number: NCT07359391

Dual Approach External Oblique Fascial Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Percutaneous Nephrolithotomy

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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.

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Key information

About this study

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Dual External Oblique Fascial Plane Block

Procedure

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.

General Anesthesia

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Acronym: BLOCK-PCNL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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