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Here is a **patient-friendly, ClinicalTrials.gov-compliant Brief Summary** written in **plain language**, avoiding technical jargon as much as possible while remaining accurate.
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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.
Full description
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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.
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Inclusion and exclusion criteria
Inclusion Criteria:
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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90 participants in 3 patient groups
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