Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures

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.

Study Overview

• Status: Completed
• Conditions: Lower Abdominal Oncologic Surgery
• Intervention / Treatment: Drug: Placebo-nalbuphine; Drug: Dexamethasone-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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • mansoura university, faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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%	Drug: 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%
Active Comparator: 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%	Drug: 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain visual analog score (0: no pain, 100: worst imaginable pain)	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed A Ghanem, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 7, 2018

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Dexamethasone; Nalbuphine
• Other Study ID Numbers: R/17.04.127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No