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Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLB with 0,375% ropivacaine | Experimental |
| |
| QLB with 0,9% NaCl | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qadratus Lumborum Block | Procedure | Bilateral, ultrasound - guided Quadratus Lumborum Block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption following prostatectomy | Oxycodone consumption with Patient-Controlled Analgesia pump | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain scores assessed with Numeric Rating Scale (NRS).In this scale pain intensity is expressed using one of the numbers 0 - 10, 0 being no pain and 10 worst pain imaginable. | 24 hours |
| Time to first dose of opioid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Malec-Milewska, MD, PhD | Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care | Warsaw | 01-813 | Poland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Double blind, placebo-controlled, randomised
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Solution used for block (local anesthetic or placebo) is known to anesthetist not involved in patient's care.
| 30 milliliters of 0.375% Ropivacaine | Drug | 30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block |
|
| 30 milliliters of 0.9% NaCl | Drug | 30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block |
|
Time in minutes from emergence from anesthesia to the first request for opioid
| 24 hours |
| Opioids - related complications | The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching | 24 hours |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |