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The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.
Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.
One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Plane Block group | Experimental | Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. |
|
| Intravenous patient-controlled analgesia group | Active Comparator | Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain 25% (Erector Spinae Plane Block) | Drug | Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The time of first rescue analgesia | Time from end of surgery to first dose of morphine administrated. | 48 hours postoperatively |
| Degree of pain | Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University | Kafr ash Shaykh | Kafrelsheikh | 33516 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine (Intravenous patient-controlled analgesia) | Drug | Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine |
|
| 48 hours postoperatively |
| Incidence of side effects | Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate <10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed. | 48 hours postoperatively |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |