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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative RSB Group | Active Comparator | The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block prior to the surgical procedure |
|
| Postoperative RSB Group | Active Comparator | The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early bilateral rectus sheat block | Procedure | Bilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption at postoperative 1st 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 |
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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:
Male sex
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafet O Gorgulu, M.D | Contact | +905387317139 | ronurgorgulu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koc University Hospital | Istanbul | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228979 | Background | 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. | |
| 30829658 | Background |
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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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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
|
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 | 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 | 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 | Pain measured by Numeric Rating Scale (0-10) | At the end of the postoperative 1st hour |
| Pain at postoperative 6th hour | Pain measured by Numeric Rating Scale (0-10) | At the end of the postoperative 6th hour |
| Pain at postoperative 12th hour | Pain measured by Numeric Rating Scale (0-10) | At the end of the postoperative 12th hour |
| Pain at postoperative f24th hour | Pain measured by Numeric Rating Scale (0-10) | At the end of the postoperative 24th hour |
| Rescue analgesia | Total rescue fentanyl administered (mcg) | 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 | At the end of the 24th postoperative hour |
| 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. |
| 39853690 | 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. |
| 38669407 | 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. |
| 29739537 | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |