Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy

NCT07653230 | Completed

• 1 other identifier: E-24-130
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain. This study compares two different concentrations of bupivacaine, a local anesthetic medication, used during ESPB. Participants undergoing PNL will receive either 0.25% or 0.375% bupivacaine as part of their pain management. Researchers will compare pain scores, the need for additional pain medication, and changes in blood markers related to inflammation after surgery. The aim of the study is to determine whether one concentration provides better pain control or influences the inflammatory response differently after PNL.

Conditions

Percutaneous Nephrolithotomy (PNL); Nephrolithiasis

Keywords

erector spina plane block; nephrolithiasis; percutaneous nephrolithotomy; bupivacaine; different concentrations

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption

  Postoperative pain intensity was assessed using the Visual Analog Scale (VAS; 0-10), where higher scores indicate greater pain severity. Pain scores and Total intraoperative and postoperative opioid consumption were recorded at 1, 3, 6, 12, 24, and 36 hours after surgery.

  36 hours after surgery

Secondary Outcomes (1)

• inflammatory markers

  24 hours after surgery

Study Arms (2)

group 1

0.25% Bupivacaine ESPB

Procedure: Erector spinae plane block (ESPB)

group 2

0.375% bupivacaine ESPB

Procedure: Erector spinae plane block (ESPB)

Interventions

Erector spinae plane block (ESPB) PROCEDURE

Ultrasound-guided thoracic erector spinae plane block was performed at the T10 vertebral level before surgery by an experienced anesthesiologist. A total volume of 20 mL bupivacaine was administered. Participants received either 0.25% or 0.375% bupivacaine according to the study cohort. The block was used as part of a multimodal analgesia protocol for postoperative pain management following percutaneous nephrolithotomy.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult patients undergoing elective percutaneous nephrolithotomy (PNL) for renal stone disease at a single tertiary care center between July 2024 and March 2025. Eligible participants were 18-70 years of age, classified as American Society of Anesthesiologists (ASA) physical status I-III, and received ultrasound-guided thoracic erector spinae plane block (ESPB) as part of perioperative analgesic management. A total of 60 participants were included and prospectively followed throughout the postoperative period.

You may qualify if:

• Age between 18 and 70 years.
• Scheduled to undergo elective percutaneous nephrolithotomy (PNL).
• American Society of Anesthesiologists (ASA) physical status I-III.
• Received ultrasound-guided thoracic erector spinae plane block (ESPB) before surgery.
• Willing and able to provide written informed consent.

You may not qualify if:

• Inability to assess pain using the Visual Analog Scale (VAS).
• Advanced cardiovascular disease.
• Coagulopathy or bleeding disorders.
• Opioid use disorder.
• Body mass index (BMI) ≥ 40 kg/m².
• Infection at the planned injection site.
• Known allergy or hypersensitivity to bupivacaine, other local anesthetics, or study-related medications.
• Withdrawal of consent during the study period.

Sponsors & Collaborators

• Ankara Education and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Mamak, 06420, Turkey (Türkiye)

Location

Related Publications (2)

• Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.

  PMID: 30832580 RESULT

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 RESULT

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• suna akın takmaz, proffessor doctor

  University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: July 1, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 19, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)