Effect of Rectus Block Timing on Opioid Use (PROSTIMERSBOP)

February 19, 2026 updated by: Rafet Onur Gorgulu, Koç University Hospital

The Effect of Timing of Rectus Sheath Blockade During Robotic Prostate Surgery on Opioid Consumption: A Randomized Double-Blind Study

The aim of this study is to observe the effect of administering local anesthetic to the abdominal wall at the beginning or end of surgery under general anesthesia on opioid consumption during surgery. The hypothesis of this study is to demonstrate that administering a rectus sheath block before the surgical procedure under general anesthesia is effective in reducing intraoperative opioid consumption and opioid-related side effects compared to administering it after the surgery is completed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-ASA (American Society of Anesthesiologists) I-III adult patients with prostate cancer and benign prostate diseases scheduled for robotic surgery at Koç University Hospital.

Exclusion Criteria:

  • <18 years of age
  • ASA (American Society of Anesthesiologists) IV, V patients
  • Non-elective emergency cases
  • Previous major abdominal/pelvic surgery
  • History of significant psychiatric disorders
  • Patients who may have contraindications to nerve blocks (bleeding diathesis, infection, and local anesthetic allergy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Preoperative RSB Group
The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block prior to the surgical procedure
Procedure: Early bilateral rectus sheat block
Bilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery
Active Comparator: Postoperative RSB Group
The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure
Procedure: Late bilateral rectus sheat block
Bilateral rectus sheat block will be performed after the completion of the surgery, before the end of general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total intraoperatif remifentanil consumption
Time Frame: Total operative duration
Total operative duration
Average intraoperative remifentanil consumption
Time Frame: Total operative duration
Total intraoperative remifentail consumption divided by the weight of the patient (kg) and total operative duration (minutes). (mcg/kg/dk)
Total operative duration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption at postoperative 1st hour
Time Frame: From the end of the surgery to the end of the first postoperative hour
Cumulative opioid consumption at postoperative 1st hour in IV morphine equivalent
From the end of the surgery to the end of the first postoperative hour
Cumulative opioid consumption at postoperative 6th hour
Time Frame: From the end of the surgery to the end of the 6th postoperative hour
Cumulative opioid consumption at postoperative 6th hour in IV morphine equivalent
From the end of the surgery to the end of the 6th postoperative hour
Cumulative opioid consumption at postoperative 12th hour
Time Frame: From the end of the surgery to the end of the 12th postoperative hour
Cumulative opioid consumption at postoperative 12th hour in IV morphine equivalent
From the end of the surgery to the end of the 12th postoperative hour
Cumulative opioid consumption at postoperative 24th hour
Time Frame: From the end of the surgery to the end of the 24th postoperative hour
Cumulative opioid consumption at postoperative 24th hour in IV morphine equivalent
From the end of the surgery to the end of the 24th postoperative hour
Pain at postoperative first hour
Time Frame: At the end of the postoperative 1st hour
Pain measured by Numeric Rating Scale (0-10)
At the end of the postoperative 1st hour
Pain at postoperative 6th hour
Time Frame: At the end of the postoperative 6th hour
Pain measured by Numeric Rating Scale (0-10)
At the end of the postoperative 6th hour
Pain at postoperative 12th hour
Time Frame: At the end of the postoperative 12th hour
Pain measured by Numeric Rating Scale (0-10)
At the end of the postoperative 12th hour
Pain at postoperative f24th hour
Time Frame: At the end of the postoperative 24th hour
Pain measured by Numeric Rating Scale (0-10)
At the end of the postoperative 24th hour
Rescue analgesia
Time Frame: From the end of the surgery to the end of the first postoperative hour
Total rescue fentanyl administered (mcg)
From the end of the surgery to the end of the first postoperative hour
Patient satisfaction
Time Frame: At the end of the 24th postoperative hour
Patient satisfaction reported by the patient in a scale from 1 to 5
At the end of the 24th postoperative hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025.250.IRB2.116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available. De-identified data may be shared upon reasonable request to the corresponding author, subject to institutional approval and a data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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