A Phase 4 interventional study of Esmolol in Postoperative Pain, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by Benha University · Phase 4, Interventional, and Treatment
Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
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10 minutes before induction of anesthesia the patients will receive a loading dose of injection esmolol 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side .
Drug: Esmolol
10 minutes before induction of anesthesia the patients will receive a loading dose of injection 30 ml isotonic saline in the iv line, followed by an IV infusion of saline at a rate of 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side.
Drug: Esmolol
administration of a loading dose esmolol infusion 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery
pain rescue-analgesia consumption
. If pain score exceed 3, rescue analgesia 5 mg bolus of morphine will be administered intravenous to achieve satisfactory pain control that can be repeated every 4-6 hours.
Time frame: 24 hours postoperative
Visual analogue pain score
scales from zero (no pain) to ten (unbearable pain)
Time frame: every 0,2,4,6,12, up to 24 hours postoperative
Intraoperative hemodynamic data
mean arterial blood pressure and heart rate
Time frame: 30 minutes after induction of anesthesia
Postoperative nausea and vomiting
A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting. Ondansetron 4 mg will be available if required.
Time frame: 24 hours postoperative
Patient satisfaction
using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").
Time frame: 24 hours postoperative
Plan to share: Undecided
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Benha University