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

This study is currently recruiting participants.
Verified January 2017 by Abdelrady S Ibrahim, MD, Assiut University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02716129
First Posted: March 23, 2016
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Drug: Morphine Drug: Morphine plus Nalbuphine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine

Resource links provided by NLM:


Further study details as provided by Abdelrady S Ibrahim, MD, Assiut University:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 24 hours ]
    Visual Analogue Score


Secondary Outcome Measures:
  • Incidence of postoperative itching [ Time Frame: 24 hours ]
    Visual Analogue Score

  • number of participants with incidence of postoperative nausea [ Time Frame: 24 hours ]
    Patients number

  • number of participants with incidence of postoperative vomiting [ Time Frame: 24 hours ]
    Patients number

  • number of participants with incidence of postoperative postdural puncture headache [ Time Frame: 24 hours ]
    Patients number

  • number of participants with incidence of postoperative respiratory depression [ Time Frame: 24 hours ]
    Patients number


Estimated Enrollment: 70
Study Start Date: March 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Morphine group
Drug: Morphine
35 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.
Other Name: Infumorph
Active Comparator: Group 2
Morphine plus Nalbuphine group
Drug: Morphine plus Nalbuphine
35 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) 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.
Other Name: Infumorph and NALUFIN

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716129


Contacts
Contact: Abdelrady S Ibrahim, MD 00201026249924 aradys2004@gmail.com
Contact: Rady I Sayed 0020882358865 aradys2000@yahoo.com

Locations
Egypt
Assiut university faculty of medicine Recruiting
Assiut, Egypt
Contact: Abdelrady S Ibrahim, MD    00201026249924    aradys2004@gmail.com   
Sponsors and Collaborators
Abdelrady S Ibrahim, MD
Investigators
Principal Investigator: Abdelrady S Ibrahim, MD Assistant professor of anesthesia and intensive care
  More Information

Publications:
Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT02716129     History of Changes
Other Study ID Numbers: IRB0000871235
First Submitted: March 15, 2016
First Posted: March 23, 2016
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Nalbuphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists