Clinical trial NCT03276325: Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery
Official title: Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Abdominal Oncologic Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: For 24 hours after surgery
measure: Sensory recovery
timeFrame: For 5 hours after induction of anaesthesia
measure: Motor recovery
timeFrame: For 5 hours after induction of anaesthesia
measure: First analgesic request
timeFrame: For 12 hours after induction of anaesthesia
measure: Intraoperative heart rate changes
timeFrame: For 3 hours after induction of anaesthesia
measure: Intraoperative mean arterial blood pressure changes
timeFrame: For 3 hours after induction of anaesthesia
measure: Postoperative heart rate changes
timeFrame: For 24 hours after surgery
measure: Postoperative mean arterial blood pressure changes
timeFrame: For 24 hours after surgery
measure: Cumulative use of antiemetic
timeFrame: for 24 hrs after surgery
measure: Cumulative use of rescue intravenous ketorolac
timeFrame: for 24 hrs after surgery
measure: Cumulative use of rescue intravenous nalbuphine
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Faculty of Medicine
state: DK
Study officials:
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Mohamed A Ghanem, MD
role: STUDY_CHAIR
References: