An interventional study of Placebo-nalbuphine and Dexamethasone-nalbuphine in Lower Abdominal Oncologic Surgery, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Mansoura University · Not applicable, Interventional, and Other
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine \& IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.
Exclusion Criteria:
Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Drug: Placebo-nalbuphine
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Drug: Dexamethasone-nalbuphine
Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Pain score
Pain visual analog score (0: no pain, 100: worst imaginable pain)
Time frame: For 24 hours after surgery
Nausea and vomiting
(0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)
Time frame: For 24 hours after surgery
Sensory recovery
Regression to S1 spinal segment as tested with cold sensation
Time frame: For 5 hours after induction of anaesthesia
Motor recovery
The time until decreased a modified Bromage score of 0 (i.e. full leg movement)
Time frame: For 5 hours after induction of anaesthesia
First analgesic request
Time to first request of rescue analgesic
Time frame: For 12 hours after induction of anaesthesia
Intraoperative heart rate changes
Changes in heart rate during surgery
Time frame: For 3 hours after induction of anaesthesia
Intraoperative mean arterial blood pressure changes
Changes in mean arterial blood pressure during surgery
Time frame: For 3 hours after induction of anaesthesia
Postoperative heart rate changes
Changes in heart rate after surgery
Time frame: For 24 hours after surgery
Postoperative mean arterial blood pressure changes
Changes in mean arterial blood pressure after surgery
Time frame: For 24 hours after surgery
Cumulative use of antiemetic
Cumulative use of metoclopramide and ondansetron after surgery
Time frame: for 24 hrs after surgery
Cumulative use of rescue intravenous ketorolac
Rescue use of ketorolac in case of severe pain conditions
Time frame: for 24 hrs after surgery
Cumulative use of rescue intravenous nalbuphine
Rescue use of nalbuphine in case of severe pain conditions
Time frame: For 24 hours after surgery
Plan to share: Undecided
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Mansoura University