NCT04618146

Brief Summary

This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

November 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

November 10, 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

4 months

First QC Date

November 1, 2020

Last Update Submit

February 26, 2021

Conditions

Pain, PostoperativePruritusNausea, PostoperativeVomiting, Postoperative

Keywords

painmorphinecesarean sectionenhanced recovery

Outcome Measures

Primary Outcomes (3)

  • Pain postoperative

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    2 hours postoperatively

  • Pain postoperative

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    4 hours postoperatively

  • Pain postoperative

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    24 hours postoperatively

Secondary Outcomes (7)

  • vomiting

    2 hours postoperative

  • vomiting

    4 hours postoperative

  • vomiting

    24 hours postoperative

  • itching

    2 hours postoperative

  • itching

    4 hours postoperative

  • +2 more secondary outcomes

Study Arms (3)

Group C

PLACEBO COMPARATOR

given intrathecal bupivacaine 12.5 mg.

Drug: Bupivacaine Hydrochloride

Group M25

ACTIVE COMPARATOR

given intrathecal bupivacaine 12.5mg + morphine 25 microgram.

Drug: Morphine SulfateDrug: Bupivacaine Hydrochloride

Group M50

ACTIVE COMPARATOR

given intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Drug: Morphine SulfateDrug: Bupivacaine Hydrochloride

Interventions

Morphine SulfateDRUG

intrathecal low dose morphine for early return to normal activity without opioid related complications.

Also known as: morphine
Group M25Group M50
Bupivacaine HydrochlorideDRUG

intrathecal bupivacaine 0.5%

Also known as: marcaine
Group CGroup M25Group M50

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales presenting for cesarean section
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females scheduled for cesarean section
  • Age: 16-45 yrs.
  • Gestation age \>38 weeks.
  • ASA I,II

You may not qualify if:

  • Refusal to participate.
  • Significant cardiac, hepatic or renal dysfunction.
  • History of chronic itching problem, or hyperemesis during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePruritusPostoperative Nausea and VomitingPain

Interventions

MorphineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

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

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
not applicable
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

November 1, 2020

First Posted

November 5, 2020

Study Start

November 10, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

EG(1)