Lower Abdominal Oncologic Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo-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%
DRUGDexamethasone-nalbuphine
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical class I or II. * Undergoing laparotomy * Undergoing oophorectomy * Undergoing hysterectomy * Undergoing rectal mass excision
Exclusion criteria
* Patient refusal. * Hypersensitivity to amide local anesthetics. * General contraindications to spinal anesthesia. * Cardiac diseases. * Hepatic failure. * Renal failure. * Respiratory failure. * Communication barriers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | For 24 hours after surgery | Pain visual analog score (0: no pain, 100: worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and vomiting | For 24 hours after surgery | (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting) |
| Sensory recovery | For 5 hours after induction of anaesthesia | Regression to S1 spinal segment as tested with cold sensation |
| Motor recovery | For 5 hours after induction of anaesthesia | The time until decreased a modified Bromage score of 0 (i.e. full leg movement) |
| First analgesic request | For 12 hours after induction of anaesthesia | Time to first request of rescue analgesic |
| Intraoperative heart rate changes | For 3 hours after induction of anaesthesia | Changes in heart rate during surgery |
| Intraoperative mean arterial blood pressure changes | For 3 hours after induction of anaesthesia | Changes in mean arterial blood pressure during surgery |
| Postoperative heart rate changes | For 24 hours after surgery | Changes in heart rate after surgery |
| Postoperative mean arterial blood pressure changes | For 24 hours after surgery | Changes in mean arterial blood pressure after surgery |
| Cumulative use of antiemetic | for 24 hrs after surgery | Cumulative use of metoclopramide and ondansetron after surgery |
| Cumulative use of rescue intravenous ketorolac | for 24 hrs after surgery | Rescue use of ketorolac in case of severe pain conditions |
| Cumulative use of rescue intravenous nalbuphine | For 24 hours after surgery | Rescue use of nalbuphine in case of severe pain conditions |
Countries
Egypt
Outcome results
None listed