Prostate CancerPROSTIMERSBOPNCT07433140
Effect of Rectus Block Timing on Opioid Use
A study testing Early bilateral rectus sheat block and Late bilateral rectus sheat block in people with Prostate Cancer and Pain Management, run by Koc University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Pain Management, Nociception Level Index(NoL)
- What is being tested?
- Early bilateral rectus sheat block and Late bilateral rectus sheat block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 May 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -ASA (American Society of Anesthesiologists) I-III adult patients with prostate cancer and benign prostate diseases scheduled for robotic surgery at Koç University Hospital.
Who cannot join
- <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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Pain Management, Nociception Level Index(NoL), Nociception Monitoring, Opioid Consumption
- Being tested
- Early bilateral rectus sheat block, Late bilateral rectus sheat block
- Keywords
- Robot Surgery, Rectus sheath block, Nociception, opioid, Cancer of Prostate
- Medical subject headings
- Prostatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early bilateral rectus sheat blockProcedure or surgery
Bilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery
Late bilateral rectus sheat blockProcedure or surgery
Bilateral rectus sheat block will be performed after the completion of the surgery, before the end of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Preoperative RSB Group | Active comparator | The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block prior to the surgical procedure Receives: Procedure: Early bilateral rectus sheat block |
| Postoperative RSB Group | Active comparator | The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure Receives: Procedure: Late bilateral rectus sheat block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperatif remifentanil consumption
Measured: Total operative duration
Average intraoperative remifentanil consumption
Total intraoperative remifentail consumption divided by the weight of the patient (kg) and total operative duration (minutes). (mcg/kg/dk)
Measured: Total operative duration
Secondary outcomes (10)
Cumulative opioid consumption at postoperative 1st hour
Cumulative opioid consumption at postoperative 1st hour in IV morphine equivalent
Measured: From the end of the surgery to the end of the first postoperative hour
Cumulative opioid consumption at postoperative 6th hour
Cumulative opioid consumption at postoperative 6th hour in IV morphine equivalent
Measured: From the end of the surgery to the end of the 6th postoperative hour
Cumulative opioid consumption at postoperative 12th hour
Cumulative opioid consumption at postoperative 12th hour in IV morphine equivalent
Measured: From the end of the surgery to the end of the 12th postoperative hour
Cumulative opioid consumption at postoperative 24th hour
Cumulative opioid consumption at postoperative 24th hour in IV morphine equivalent
Measured: From the end of the surgery to the end of the 24th postoperative hour
Pain at postoperative first hour
Pain measured by Numeric Rating Scale (0-10)
Measured: At the end of the postoperative 1st hour
Pain at postoperative 6th hour
Pain measured by Numeric Rating Scale (0-10)
Measured: At the end of the postoperative 6th hour
Pain at postoperative 12th hour
Pain measured by Numeric Rating Scale (0-10)
Measured: At the end of the postoperative 12th hour
Pain at postoperative f24th hour
Pain measured by Numeric Rating Scale (0-10)
Measured: At the end of the postoperative 24th hour
Rescue analgesia
Total rescue fentanyl administered (mcg)
Measured: From the end of the surgery to the end of the first postoperative hour
Patient satisfaction
Patient satisfaction reported by the patient in a scale from 1 to 5
Measured: At the end of the 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 Mar 2026
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafet Onur Gorgulu, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433140
- Sponsor's protocol ID
- 2025.250.IRB2.116
- Acronym
- PROSTIMERSBOP
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
PubMed 33228979Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
PubMed 30829658Lumme A, Kalliomaki ML, Harju J, Nordstrom P. Combining Transversus Abdominis Plane and Rectus Sheath Blocks in Open Inguinal Hernia Surgery Anesthesia: A Retrospective Cohort Analysis. World J Surg. 2025 Mar;49(3):626-633. doi: 10.1002/wjs.12481. Epub 2025 Jan 23.
PubMed 39853690Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.
PubMed 38669407Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
PubMed 29739537
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timing of Rectus Sheath Blockade During Robotic Prostate Surgery on Opioid Consumption: A Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT07433140
- Acronym / sponsor ID
- PROSTIMERSBOP / 2025.250.IRB2.116
- Conditions
- Prostate Cancer, Pain Management, Nociception Level Index(NoL), Nociception Monitoring, Opioid Consumption
- Keywords
- Robot Surgery, Rectus sheath block, Nociception, opioid, Cancer of Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative RSB Group | Active comparator | Procedure: Early bilateral rectus sheat blockThe group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block prior to the surgical procedure |
| Postoperative RSB Group | Active comparator | Procedure: Late bilateral rectus sheat blockThe group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -ASA (American Society of Anesthesiologists) I-III adult patients with prostate cancer and benign prostate diseases scheduled for robotic surgery at Koç University Hospital.
Key exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early bilateral rectus sheat blockBilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery | Procedure or surgery | Preoperative RSB Group |
| Late bilateral rectus sheat blockBilateral rectus sheat block will be performed after the completion of the surgery, before the end of general anesthesia | Procedure or surgery | Postoperative RSB Group |
Primary outcome
Total intraoperatif remifentanil consumption
Time frame: 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)
10 secondary outcomes
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 6th hour
Time frame: 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 24th hour
Time frame: 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 at postoperative 6th hour
Time frame: At the end of the postoperative 6th hour
Pain at postoperative 12th hour
Time frame: At the end of the postoperative 12th hour
Pain at postoperative f24th hour
Time frame: 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
Patient satisfaction
Time frame: At the end of the 24th postoperative hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 33228979Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
- Background: PubMed 30829658Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
- Background: PubMed 39853690Lumme A, Kalliomaki ML, Harju J, Nordstrom P. Combining Transversus Abdominis Plane and Rectus Sheath Blocks in Open Inguinal Hernia Surgery Anesthesia: A Retrospective Cohort Analysis. World J Surg. 2025 Mar;49(3):626-633. doi: 10.1002/wjs.12481. Epub 2025 Jan 23.
- Background: PubMed 38669407Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.
- Background: PubMed 29739537Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early bilateral rectus sheat block and Late bilateral rectus sheat block in people with Prostate Cancer and Pain Management, run by Koc University Hospital 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 1 inclusion and 6 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 3 Aug 2026. 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?
Total intraoperatif remifentanil consumption (time frame: Total operative duration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433140, which also lists 5 linked publications.
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 3 Aug 2026.