An interventional study of Standard analgesia (paracetamol +fentanyl) and Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone in Opioid Free Anesthesia, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.
Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv
Procedure: Standard analgesia (paracetamol +fentanyl)
Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.
Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone
Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv
Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.
The recovery time
The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.
Time frame: up to 1 hour postoperative
pain intensity
pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain
Time frame: up to 24 hours postoperative
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Zagazig University