Nociception Level Index(NoL), Nociception Monitoring, Opioid Consumption, Pain Management, Prostate Cancer
Conditions
Keywords
Robot Surgery, Rectus sheath block, Nociception, opioid, Cancer of Prostate
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.
Interventions
PROCEDUREEarly bilateral rectus sheat block
Bilateral rectus sheat block will be performed after the anesthesia induction, before the start of the surgery
PROCEDURELate bilateral rectus sheat block
Bilateral rectus sheat block will be performed after the completion of the surgery, before the end of general anesthesia
Sponsors
Koc University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperatif remifentanil consumption | Total operative duration | — |
| Average intraoperative remifentanil consumption | Total operative duration | Total intraoperative remifentail consumption divided by the weight of the patient (kg) and total operative duration (minutes). (mcg/kg/dk) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 1st hour in IV morphine equivalent |
| 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 6th hour in IV morphine equivalent |
| 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 12th hour in IV morphine equivalent |
| Cumulative opioid consumption at postoperative 24th hour | 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 |
| Pain at postoperative first hour | At the end of the postoperative 1st hour | Pain measured by Numeric Rating Scale (0-10) |
| Pain at postoperative 6th hour | At the end of the postoperative 6th hour | Pain measured by Numeric Rating Scale (0-10) |
| Pain at postoperative 12th hour | At the end of the postoperative 12th hour | Pain measured by Numeric Rating Scale (0-10) |
| Pain at postoperative f24th hour | At the end of the postoperative 24th hour | Pain measured by Numeric Rating Scale (0-10) |
| Rescue analgesia | From the end of the surgery to the end of the first postoperative hour | Total rescue fentanyl administered (mcg) |
| Patient satisfaction | At the end of the 24th postoperative hour | Patient satisfaction reported by the patient in a scale from 1 to 5 |
Countries
Turkey (Türkiye)
Outcome results
None listed