Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery
- Conditions
- Lower Abdominal Oncologic Surgery
- Interventions
- Drug: Placebo-nalbuphineDrug: Dexamethasone-nalbuphine
- Registration Number
- NCT03276325
- Lead Sponsor
- Mansoura University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- American Society of Anesthesiologists physical class I or II.
- Undergoing laparotomy
- Undergoing oophorectomy
- Undergoing hysterectomy
- Undergoing rectal mass excision
- Patient refusal.
- Hypersensitivity to amide local anesthetics.
- General contraindications to spinal anesthesia.
- Cardiac diseases.
- Hepatic failure.
- Renal failure.
- Respiratory failure.
- Communication barriers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo-nalbuphine Placebo-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% Dexamethasone-nalbuphine Dexamethasone-nalbuphine Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
- Primary Outcome Measures
Name Time Method Pain score For 24 hours after surgery Pain visual analog score (0: no pain, 100: worst imaginable pain)
- Secondary Outcome Measures
Name Time Method Sensory recovery For 5 hours after induction of anaesthesia Regression to S1 spinal segment as tested with cold sensation
Nausea and vomiting For 24 hours after surgery (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)
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
Trial Locations
- Locations (1)
Mansoura University, Faculty of Medicine
🇪🇬Mansourah, DK, Egypt