Effect of Rectus Block Timing on Opioid Use

NCT07433140 | Not Yet Recruiting

• 1 other identifier: 2025.250.IRB2.116
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Robot Surgery; Rectus sheath block; Nociception; opioid; Cancer of Prostate

Outcome Measures

Primary Outcomes (2)

• Total intraoperatif remifentanil consumption

  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)

  Total operative duration

Secondary Outcomes (10)

• Cumulative opioid consumption at postoperative 1st hour

  From the end of the surgery to the end of the first postoperative hour

• Cumulative opioid consumption at postoperative 6th hour

  From the end of the surgery to the end of the 6th postoperative hour

• Cumulative opioid consumption at postoperative 12th hour

  From the end of the surgery to the end of the 12th postoperative hour

• Cumulative opioid consumption at postoperative 24th hour

  From the end of the surgery to the end of the 24th postoperative hour

• Pain at postoperative first hour

  At the end of the postoperative 1st hour

Study Arms (2)

Preoperative RSB Group

ACTIVE COMPARATOR

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

Postoperative RSB Group

ACTIVE COMPARATOR

The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure

Procedure: Late bilateral rectus sheat block

Interventions

Early bilateral rectus sheat block PROCEDURE

Bilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery

Preoperative RSB Group

Late bilateral rectus sheat block PROCEDURE

Bilateral rectus sheat block will be performed after the completion of the surgery, before the end of general anesthesia

Postoperative RSB Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Koc University Hospital: lead

Study Sites (1)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 33228979 BACKGROUND

• Meijer 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.

  PMID: 30829658 BACKGROUND

• Lumme 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.

  PMID: 39853690 BACKGROUND

• Cosarcan 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.

  PMID: 38669407 BACKGROUND

• Lavand'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.

  PMID: 29739537 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rafet O Gorgulu, M.D

CONTACT

+905387317139; ronurgorgulu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rafet Onur Gorgulu, MD, Resident of Anesthesiology and Reanimation, Department of Anesthesiology, Koc University Hospital

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 25, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)