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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-nalbuphine | Placebo Comparator | Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
|
| Dexamethasone-nalbuphine | Active Comparator | Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo-nalbuphine | Drug | Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain visual analog score (0: no pain, 100: worst imaginable pain) | For 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and vomiting | (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting) | For 24 hours after surgery |
| Sensory recovery | Regression to S1 spinal segment as tested with cold sensation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Ghanem, MD | Assistant Professor of Anesthesia and Surgical Intensive Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University, Faculty of Medicine | Al Mansurah | DK | 050 | Egypt |
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Double blind
| Dexamethasone-nalbuphine | Drug | Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% |
|
| For 5 hours after induction of anaesthesia |
| Motor recovery | The time until decreased a modified Bromage score of 0 (i.e. full leg movement) | For 5 hours after induction of anaesthesia |
| First analgesic request | Time to first request of rescue analgesic | For 12 hours after induction of anaesthesia |
| Intraoperative heart rate changes | Changes in heart rate during surgery | For 3 hours after induction of anaesthesia |
| Intraoperative mean arterial blood pressure changes | Changes in mean arterial blood pressure during surgery | For 3 hours after induction of anaesthesia |
| Postoperative heart rate changes | Changes in heart rate after surgery | For 24 hours after surgery |
| Postoperative mean arterial blood pressure changes | Changes in mean arterial blood pressure after surgery | For 24 hours after surgery |
| Cumulative use of antiemetic | Cumulative use of metoclopramide and ondansetron after surgery | for 24 hrs after surgery |
| Cumulative use of rescue intravenous ketorolac | Rescue use of ketorolac in case of severe pain conditions | for 24 hrs after surgery |
| Cumulative use of rescue intravenous nalbuphine | Rescue use of nalbuphine in case of severe pain conditions | For 24 hours after surgery |