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AnalgesiaESBPblockNCT06928324

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

A study testing Erector Spinae Plane block in people with Analgesia, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Analgesia
What is being tested?
Erector Spinae Plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2025to 15 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kudret Doğru

    Kayseri, 38050

Other trials in Turkey (Türkiye)

About this study

Official title: Providing Postoperative Analgesia With an Erector Spinae Plane Block in Robotic-assisted Partial Nephrectomy

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.

Conditions
Analgesia
Being tested
Erector Spinae Plane block, Control
Keywords
pain, prostatectomy, erector spinae block
Medical subject headings
Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane blockProcedure or surgery

    Also called ESBP 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

  • ControlProcedure or surgery

    Also called Not ESBP Block

    No intervention

Study groups in NCT06928324
Study groupRoleWhat they receive
ESPB groupActive comparatorReceiving ESPB 30 ml bupivacaine 0.25%
Receives: Procedure: Erector Spinae Plane block
control groupActive comparatorNot receiving ESBP
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reducing patient-controlled analgesic consumption

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

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

Secondary outcomes (1)
  1. the satisfaction of the surgeon and the patient during the postoperative period

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2025
  2. Study start15 May 2025
  3. Primary completion15 Aug 2025
  4. Study completion15 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06928324
Sponsor's protocol ID
2025/114
Acronym
ESBPblock
Status last verified
Dec 2025
First submitted
24 Mar 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane block in people with Analgesia, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reducing patient-controlled analgesic consumption (time frame: From the patient's anesthesia induction in the operating room to the postoperative 24. hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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