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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

March 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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