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The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Morphine
Morphine plus Nalbuphine
Sponsored by
Abdelrady S Ibrahim, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients
  • age between 16 to 40 years
  • ASA physical status I - II

Exclusion Criteria:

  • 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 us

Sites / Locations

  • Assiut university faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Morphine group

Morphine plus Nalbuphine group

Outcomes

Primary Outcome Measures

Postoperative pain
Visual Analogue Score

Secondary Outcome Measures

Incidence of postoperative itching
Visual Analogue Score
number of participants with incidence of postoperative nausea
Patients number
number of participants with incidence of postoperative vomiting
Patients number
number of participants with incidence of postoperative postdural puncture headache
Patients number
number of participants with incidence of postoperative respiratory depression
Patients number

Full Information

First Posted
March 15, 2016
Last Updated
December 24, 2017
Sponsor
Abdelrady S Ibrahim, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02716129
Brief Title
The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
Official Title
Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdelrady S Ibrahim, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
Detailed Description
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Morphine group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Morphine plus Nalbuphine group
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Infumorph
Intervention Description
38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
Intervention Type
Drug
Intervention Name(s)
Morphine plus Nalbuphine
Other Intervention Name(s)
Infumorph and NALUFIN
Intervention Description
39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Visual Analogue Score
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of postoperative itching
Description
Visual Analogue Score
Time Frame
24 hours
Title
number of participants with incidence of postoperative nausea
Description
Patients number
Time Frame
24 hours
Title
number of participants with incidence of postoperative vomiting
Description
Patients number
Time Frame
24 hours
Title
number of participants with incidence of postoperative postdural puncture headache
Description
Patients number
Time Frame
24 hours
Title
number of participants with incidence of postoperative respiratory depression
Description
Patients number
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients age between 16 to 40 years ASA physical status I - II Exclusion Criteria: 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 us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrady S Ibrahim, MD
Organizational Affiliation
Assistant professor of anesthesia and intensive care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10960384
Citation
Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.
Results Reference
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The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section

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