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NCT Number: NCT07433140

Effect of Rectus Block Timing on Opioid Use

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.

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Key information

Conditions

Prostate Cancer Agnosia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nociception Level Index(NoL) Nociception Monitoring Opioid Consumption Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Early bilateral rectus sheat block

Procedure

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

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

Primary outcomes

  1. Total intraoperatif remifentanil consumption

    Time frame: Total operative duration

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Pain at postoperative first hour

    Time frame: At the end of the postoperative 1st hour

    Pain measured by Numeric Rating Scale (0-10)

  6. Pain at postoperative 6th hour

    Time frame: At the end of the postoperative 6th hour

    Pain measured by Numeric Rating Scale (0-10)

  7. Pain at postoperative 12th hour

    Time frame: At the end of the postoperative 12th hour

    Pain measured by Numeric Rating Scale (0-10)

  8. Pain at postoperative f24th hour

    Time frame: At the end of the postoperative 24th hour

    Pain measured by Numeric Rating Scale (0-10)

  9. Rescue analgesia

    Time frame: From the end of the surgery to the end of the first postoperative hour

    Total rescue fentanyl administered (mcg)

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rafet O Gorgulu, M.D

CONTACT

[email protected]

+905387317139

Sponsors and collaborators

Lead sponsor

Koc University Hospital

Other

Registry information

Official study title

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

Acronym: PROSTIMERSBOP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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