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Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

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ClinicalTrials.gov Identifier: NCT04589429
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sohair Adeeb, Minia University

Study Description
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Brief Summary:
Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.

Condition or disease Intervention/treatment Phase
Pruritus Pain, Postoperative Nausea, Postoperative Vomiting, Postoperative Drug: Morphine 10 MG/ML Drug: Nalbuphine Hydrochloride 10 MG/ML Phase 2

Detailed Description:
The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MN group
intrathecal morphine 300 micrograms+2mg nalbuphine
 Drug: Morphine 10 MG/ML
intrathecal morphine 300 micrograms
Other Name: morphine

Drug: Nalbuphine Hydrochloride 10 MG/ML
intrathecal nalbuphine 2mg.
Other Name: nalbuphine
Placebo Comparator: M group
intrathecal morphine 300 micrograms
 Drug: Morphine 10 MG/ML
intrathecal morphine 300 micrograms
Other Name: morphine


Outcome Measures
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Primary Outcome Measures :
  1. pruritus [ Time Frame: 2 hours postoperatively ]
    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

  2. pruritus [ Time Frame: 4 hours postoperatively ]
    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

  3. pruritus [ Time Frame: 24 hours postoperatively ]
    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 2 hours postoperative ]
    assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

  2. postoperative pain [ Time Frame: 4 hours postoperative ]
    assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

  3. postoperative pain [ Time Frame: 24 hours postoperative ]
    assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

  4. postoperative nausea and vomiting [ Time Frame: 2 hours postoperative ]
    four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

  5. postoperative nausea and vomiting [ Time Frame: 4 hours postoperative ]
    four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

  6. postoperative nausea and vomiting [ Time Frame: 24 hours postoperative ]
    four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

  7. Sedation [ Time Frame: 2 hours postoperative ]
    four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

  8. Sedation [ Time Frame: 4 hours postoperative ]
    four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

  9. Sedation [ Time Frame: 24 hours postoperative ]
    four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients.
  • Age 18-80yrs.
  • Elective major abdominal surgery under general anesthesia.

Exclusion Criteria:

  • Refusal to participate.
  • Skin or systemic disease with itching. Any condition which precludes performing spinal injection
Contacts and Locations
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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): NCT04589429


Contacts
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Contact: Sohair A Megalla, MD +20 120 003 6447 Sohair.Adeeb@minia.edu.eg

Locations
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Egypt
anesthesia&ICU department Recruiting
Minya, Egypt
Contact: sohair A Megalla, MD    01200036447    Sohair.Adeeb@minia.edu.eg   
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Sohair A Megalla, MD Anesthesia and ICU department, Faculty of Medicine, Minia University
More Information
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Responsible Party: Sohair Adeeb, Principle investigator, Minia University
ClinicalTrials.gov Identifier: NCT04589429    
Other Study ID Numbers: 678-9/2020
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021

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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
Keywords provided by Sohair Adeeb, Minia University:
pruritus
intrathecal morphine
intrathecal nalbuphine
Additional relevant MeSH terms:
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Pruritus
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Skin Diseases
 Skin Manifestations
Morphine
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents