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CompletedNCT06928324ESBPblockUpdated Dec 19, 2025

Postoperative Analgesia With an Erector Spinae Plane Block in Robotic-assisted Partial Nephrectomy

An interventional study of Erector Spinae Plane block and Control in Analgesia, sponsored by TC Erciyes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Partial nephrectomy is used as a standard method for the treatment of T1 kidney tumors, while radical nephrectomy is preferred for T2 tumors and localized masses that cannot be treated with partial nephrectomy. These surgical procedures can be performed using open surgery, laparoscopic, or robotic approaches. Open surgical methods, especially during partial or radical nephrectomy, generally require wide incisions extending below the costal arch. These incisions involve cutting through intercostal muscle structures, fascial layers, and subcutaneous tissues, which can lead to significant postoperative discomfort for the patient. This situation can directly affect the patient's comfort and recovery time. This study aims to investigate the effect of the erector spinae plane block, a method we routinely use for analgesic purposes in many procedures in anesthesia practice, on postoperative pain levels, analgesic consumption, patient satisfaction, and length of stay after robotic-assisted partial nephrectomy surgery.

Method: Patients ranging in age between 18 and 70 were randomly assigned to either Group 1 (ESPB 30 ml bupivacaine 0.25%) or Group 2 (Control)

Read the detailed description

Ultrasound-guided regional anesthesia techniques stand out as an effective analgesia method in patients undergoing robotic-assisted partial nephrectomy (RAPN). In recent years, one of the newly defined plane blocks under ultrasound guidance, the Erector Spina Plane (ESP) Block, has become a notable alternative in postoperative pain management (4-6). The ESP block is applied at the level of the spinous process of the T8 vertebra, providing a wide sensory block in the dermatomes from T5 to T12. This technique is performed intraoperatively when the patients are in the lateral decubitus position under general anesthesia, using an ultrasound-guided linear probe. In this study, the effects of the ESP block applied to provide intraoperative and postoperative analgesia in patients undergoing robotic-assisted partial nephrectomy on postoperative pain control will be evaluated. The effectiveness of the ESP block will be comprehensively analyzed in terms of parameters such as reducing pain levels, decreasing analgesic use, increasing patient comfort, and accelerating the postoperative recovery process. Within the scope of this prospective study, general anesthesia induction will be performed using propofol and rocuronium by standard protocols, and anesthesia maintenance will be achieved with a 4-6% combination of desflurane-O₂, remifentanil, and rocuronium intravenous infusion. All procedures will be conducted within an observational clinical research protocol framework, and patients will not be subjected to any methods other than routine practices. Before the study begins, patients will be thoroughly informed, and their written consent will be obtained. The study is planned to start in April 2025.

The patient groups that will not be included in the study are as follows:

  • Patients classified as ASA III or IV,
  • Patients with cardiopulmonary difficulties,
  • Patients who have previously been diagnosed with diabetes,
  • Conditions requiring emergency surgery,
  • Patients who refuse to participate in the study,
  • Individuals with contraindications for general anesthesia,
  • Patients with less than 50 kg or more than 110 kg. Patients will be placed in the lateral decubitus position during the surgical procedure, and the surgical site will be prepared under sterile conditions. The Erector Spina Plan (ESP) block will be performed under ultrasound guidance as usual, using a Stimuplex block needle (30-degree angled, 21Gx4", 0.80x100) for this purpose. The block procedure will be performed at the level of the transverse process of the T8 vertebra. Throughout the surgical procedure, vital parameters (systolic, diastolic, and mean arterial pressure, heart rate, and SpO₂) will be regularly recorded at five-minute intervals. The amount of remifentanil used according to analgesic requirements will be systematically recorded during the intraoperative period. The patients' pain levels and analgesic needs will be assessed in the postoperative period at 1, 12, and 24 hours. In addition, the amount of morphine consumed and the need for additional analgesics based on postoperative analgesia requirements will be recorded in detail in both groups. Postoperative pain management will be provided using a patient-controlled analgesia (PCA) device by routine protocols. The PCA device offers effective and reliable pain control by allowing patients to meet their analgesic needs on an individual level. Patients will undergo robotic-assisted partial nephrectomy, and by the surgical procedure, postoperative pain management will be monitored for 24 hours, with potential complications being meticulously recorded. Postoperative pain levels will be assessed in patients both at rest and during coughing using a 0-10 Visual Analog Scale (VAS). When the pain score exceeds 3/10, 1000 mg of intravenous paracetamol will be administered as a rescue analgesic. The time of the patients' first mobilization will be recorded, and the satisfaction level of both the surgeon and the patient during the postoperative period will be rated as 1 (Excellent), 2 (Good), and 3 (Poor). Additionally, the presence of side effects such as nausea and vomiting will also be carefully recorded. Before the study, a power analysis was conducted within the framework of the central hypothesis, based on the postoperative pain rates in both groups, using the G Power (3.1.9.7 Franz Faul, Universität Kiel, Germany) program. According to data obtained from retrospective studies (6), the average morphine consumption in the group where the ESP block was applied was determined to be 16 mg. Based on the assumption that a 30% difference is clinically significant according to the unpaired t-test, a minimum of 38 patients is required for each group. However, 46 patients will be included to increase the evidence for the study.

With this calculation, the power of the study has been determined to be 0.95 and the significance level (α) to be 0.05. The normality of the data will be evaluated using the Shapiro-Wilk test, and homogeneity will be assessed using the Levene test. For data showing a normal distribution, an independent t-test will be used; for data that do not follow a normal distribution or are not homogeneous, the Mann-Whitney U test will be used; and for categorical variables, the Chi-square test will be used. The statistical significance level will be accepted as p\<0.05, and all analyses will be conducted using the Windows-compatible JAMOVI (version 2.6.19) software.

02

Conditions studied

  • Analgesia

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Keywords

  • pain, prostatectomy
  • erector spinae block
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 46 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • American Society of Anesthesiologists (ASA) Class I or II
  • Having regular preoperative visits
  • Pregnant aged 18-70

Exclusion criteria

Exclusion Criteria:

  • Patients classified as ASA III or IV,
  • Patients with cardiopulmonary difficulties,
  • Patients who have previously been diagnosed with diabetes,
  • Conditions requiring emergency surgery,
  • Patients who refuse to participate in the study,
  • Individuals with contraindications for general anesthesia,
  • Patients who weighed less than 50 kg or more than 110 kg.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    ESPB group

    Receiving ESPB 30 ml bupivacaine 0.25%

    Procedure: Erector Spinae Plane block

  • Active comparator
    control group

    Not receiving ESBP

    Procedure: Control

Interventions

  • ProcedureErector Spinae Plane block

    The Erector Spinae Plane Block (ESPB) is a technically simple and safe form of regional anesthesia that can provide effective analgesia for 12 hours in patients with acute postoperative pain

    Also known as: ESBP Block

  • ProcedureControl

    No intervention

    Also known as: Not ESBP Block

06

What researchers measure

Primary outcomes

  1. Reducing patient-controlled analgesic consumption

    The amount of analgesic consumption first 24 hours in the postoperative period

    Time frame: From the patient's anesthesia induction in the operating room to the postoperative 24. hours

Secondary outcomes

  1. the satisfaction of the surgeon and the patient during the postoperative period

    1 (Excellent), 2 (Good), and 3 (Poor)

    Time frame: From the patient's anesthesia ending to the postoperative 24. hours

07

Study locations

1 site
  • Kudret Doğru
    Kayseri, 38050, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06928324
Lead sponsor
TC Erciyes University
Responsible party
Kudret Dogru (Prof. Dr., TC Erciyes University) — Principal investigator
First posted
Apr 15, 2025
Start date
May 15, 2025
Primary completion
Aug 15, 2025
Completion
Nov 15, 2025
Last update
Dec 19, 2025

Study contacts

Kudret Doğru
study director · TC Erciyes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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