NCT02716129

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 postoperative-pain

Timeline
Completed

Started Jul 2016

Typical duration for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

March 15, 2016

Last Update Submit

December 24, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Visual Analogue Score

    24 hours

Secondary Outcomes (5)

  • Incidence of postoperative itching

    24 hours

  • number of participants with incidence of postoperative nausea

    24 hours

  • number of participants with incidence of postoperative vomiting

    24 hours

  • number of participants with incidence of postoperative postdural puncture headache

    24 hours

  • number of participants with incidence of postoperative respiratory depression

    24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Morphine group

Drug: Morphine

Group 2

ACTIVE COMPARATOR

Morphine plus Nalbuphine group

Drug: Morphine plus Nalbuphine

Interventions

MorphineDRUG

38 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.

Also known as: Infumorph
Group 1
Morphine plus NalbuphineDRUG

39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 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.

Also known as: Infumorph and NALUFIN
Group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients
  • age between 16 to 40 years
  • ASA physical status I - II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

  • Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.

    PMID: 10960384BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineNalbuphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Abdelrady S Ibrahim, MD

    Assistant professor of anesthesia and intensive care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Anesthesia and ICU

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 23, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 27, 2017

Record last verified: 2017-12

Locations

EG(1)