An interventional study of Bupivacain 25% (Erector Spinae Plane Block) and Morphine (Intravenous patient-controlled analgesia) in Erector Spinae Plane Block and Radical Cystectomy, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Prevention
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.
Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Drug: Bupivacain 25% (Erector Spinae Plane Block)
Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine
Drug: Morphine (Intravenous patient-controlled analgesia)
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.
Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine
Total morphine consumption
Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.
Time frame: 48 hours postoperatively
The time of first rescue analgesia
Time from end of surgery to first dose of morphine administrated.
Time frame: 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.
Time frame: 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.
Time frame: 48 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Kafrelsheikh University