Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

NCT ID: NCT04589429

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pruritus Pain, Postoperative Nausea, Postoperative Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MN group

intrathecal morphine 300 micrograms+2mg nalbuphine

Group Type ACTIVE_COMPARATOR

Morphine 10 MG/ML

Intervention Type DRUG

intrathecal morphine 300 micrograms

Nalbuphine Hydrochloride 10 MG/ML

Intervention Type DRUG

intrathecal nalbuphine 2mg.

M group

intrathecal morphine 300 micrograms

Group Type PLACEBO_COMPARATOR

Morphine 10 MG/ML

Intervention Type DRUG

intrathecal morphine 300 micrograms

Interventions

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Morphine 10 MG/ML

intrathecal morphine 300 micrograms

Intervention Type DRUG

Nalbuphine Hydrochloride 10 MG/ML

intrathecal nalbuphine 2mg.

Intervention Type DRUG

Other Intervention Names

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morphine nalbuphine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Sohair Adeeb

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sohair A Megalla, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and ICU department, Faculty of Medicine, Minia University

Locations

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anesthesia&ICU department

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sohair A Megalla, MD

Role: CONTACT

+20 120 003 6447

Facility Contacts

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sohair A Megalla, MD

Role: primary

01200036447

Other Identifiers

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678-9/2020

Identifier Type: -

Identifier Source: org_study_id

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