Erector Spinae Plane Block Clinical Trial
Official title:
Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
Verified date | May 2024 |
Source | Kafrelsheikh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 15, 2024 |
Est. primary completion date | January 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kafrelsheikh University | Kafr Ash Shaykh | Kafrelsheikh |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | The time of first rescue analgesia | Time from end of surgery to first dose of morphine administrated. | 48 hours postoperatively | |
Secondary | 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. | 48 hours postoperatively | |
Secondary | 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 |
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