Erector Spinae Plane Block, Radical Cystectomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine
DRUGBupivacain 25% (Erector Spinae Plane Block)
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.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age of the patient between 21 to 65 years. * Both sexes. * Body mass index (BMI): 20 - 40 kg/m2. * American Society of Anesthesiologists (ASA) physical status II-III. * Elective radical cystectomy.
Exclusion criteria
* Patient refusal. * Psychiatric and cognitive disorders. * Local infection at the site of injection. * Allergy to study medications. * Anatomic abnormalities. * Inability to comprehend or participate in pain scoring system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 48 hours postoperatively | Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time of first rescue analgesia | 48 hours postoperatively | Time from end of surgery to first dose of morphine administrated. |
| Degree of pain | 48 hours postoperatively | 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. |
| Incidence of side effects | 48 hours postoperatively | 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. |
Countries
Egypt
Outcome results
None listed