search
Back to results

a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects

Primary Purpose

Post-Op Complication

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Morphine
Morphine-Naloxone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Op Complication

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I - II
  • undergoing anal surgery with spinal anesthesia

Exclusion Criteria:

  • Renal ,hepatic and cardiac patients -Infection at the site of injection.-
  • Coagulopathy or other bleeding diathesis. -Preexisting neurologic deficits.-
  • History of hypersensitivity to any of the given the drugs.
  • Inability to communicate with the investigator and the hospital staff.
  • History of chronic opioid use.

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1

group 2

Arm Description

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\ kg naloxone in 0.5 ml volume (total volume 2mL).

Outcomes

Primary Outcome Measures

post operative vomiting
vomiting and nausea incidence

Secondary Outcome Measures

pain
will be measured by VAS

Full Information

First Posted
July 23, 2017
Last Updated
October 2, 2017
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03230474
Brief Title
a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects
Official Title
Ultra Small Dose of Intrathecal Naloxone to Minimize Morphine Induced Side- Effects in Patients Undergoing Minor Anal Surgery Under Spinal Anesthesia. A Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) so using it as additive to intrathecal morphine in patients undergoing anal surgeries under spinal anesthesia may be beneficail
Detailed Description
Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75-150 minutes, therefore, various additives have been used along with bupivacaine for the prolongation of its effect, to improve the quality of analgesia, and to minimize the requirement for postoperative analgesics . Opioids may be added to local anesthetic solutions to enhance surgical anesthesia and provide postoperative analgesia . This effect is mediated at the dorsal horn of the spinal cord, where opioids mimic the effect of endogenous enkephalins. The use of intrathecal (IT) morphine (0.1 to 0.5 mg) can provide effective control of postoperative pain for roughly 24 hours . However, the use of IT morphine may result in serious side effects e.g. pruritus 53%, nausea and vomiting 43%.urinary retention 43% and delayed respiratory depression . These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine. Naloxone has an extremely high affinity for μ-opioid receptors in the central nervous system (CNS). Naloxone is a μ-opioid receptor (MOR) competitive antagonist, and its rapid blockade of those receptors often produces rapid onset of withdrawal symptoms. Naloxone also has an antagonist action, though with a lower affinity, at κ- (KOR) and δ-opioid receptors (DOR). Unlike other opioid receptor antagonists, naloxone is essentially a pure antagonist with no agonist properties. I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) The addition of naloxone to morphine decreases the opioid related side effects without affection of postoperative analgesia. This combination can be used for the treatment of severe refractory chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\ kg naloxone in 0.5 ml volume (total volume 2mL).
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)
Intervention Type
Drug
Intervention Name(s)
Morphine-Naloxone
Intervention Description
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\ kg naloxone in 0.5 ml volume (total volume 2mL).
Primary Outcome Measure Information:
Title
post operative vomiting
Description
vomiting and nausea incidence
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain
Description
will be measured by VAS
Time Frame
24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I - II undergoing anal surgery with spinal anesthesia Exclusion Criteria: Renal ,hepatic and cardiac patients -Infection at the site of injection.- Coagulopathy or other bleeding diathesis. -Preexisting neurologic deficits.- History of hypersensitivity to any of the given the drugs. Inability to communicate with the investigator and the hospital staff. History of chronic opioid use.
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects

We'll reach out to this number within 24 hrs