NCT04589429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

September 27, 2020

Last Update Submit

February 26, 2021

Conditions

PruritusPain, PostoperativeNausea, PostoperativeVomiting, Postoperative

Keywords

pruritusintrathecal morphineintrathecal nalbuphine

Outcome Measures

Primary Outcomes (3)

  • pruritus

    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

    2 hours postoperatively

  • pruritus

    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

    4 hours postoperatively

  • pruritus

    Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

    24 hours postoperatively

Secondary Outcomes (9)

  • postoperative pain

    2 hours postoperative

  • postoperative pain

    4 hours postoperative

  • postoperative pain

    24 hours postoperative

  • postoperative nausea and vomiting

    2 hours postoperative

  • postoperative nausea and vomiting

    4 hours postoperative

  • +4 more secondary outcomes

Study Arms (2)

MN group

ACTIVE COMPARATOR

intrathecal morphine 300 micrograms+2mg nalbuphine

Drug: Morphine 10 MG/MLDrug: Nalbuphine Hydrochloride 10 MG/ML

M group

PLACEBO COMPARATOR

intrathecal morphine 300 micrograms

Drug: Morphine 10 MG/ML

Interventions

Morphine 10 MG/MLDRUG

intrathecal morphine 300 micrograms

Also known as: morphine
M groupMN group
Nalbuphine Hydrochloride 10 MG/MLDRUG

intrathecal nalbuphine 2mg.

Also known as: nalbuphine
MN group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Refusal to participate.
  • Skin or systemic disease with itching. Any condition which precludes performing spinal injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

anesthesia&ICU department

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

PruritusPain, PostoperativePostoperative Nausea and Vomiting

Interventions

MorphineNalbuphine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sohair A Megalla, MD

    Anesthesia and ICU department, Faculty of Medicine, Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohair A Megalla, MD

CONTACT

+20 120 003 6447Sohair.Adeeb@minia.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 19, 2020

Study Start

October 15, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

EG(1)