NCT02435537

Brief Summary

The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 postoperative-pain

Timeline
Completed

Started May 2013

Typical duration for phase_2 postoperative-pain

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

Study Start

First participant enrolled

May 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

April 26, 2015

Last Update Submit

May 5, 2015

Conditions

Postoperative Pain

Keywords

analgesiaintrathecalopioidsmorphinedexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • total dose of intravenous PCA morphine consumption in the first 48 h postoperative

    Calculating the cumulative intravenous PCA morphine dose

    48 hours

Secondary Outcomes (5)

  • Noninvasive blood pressure

    48 hours

  • Heart rate

    48 hours

  • peripheral arterial oxygen saturation

    48 hours

  • postoperative VAS scores

    48 hours

  • time to first request for analgesia

    48hours

Study Arms (3)

Intrathecal Bupivacaine

ACTIVE COMPARATOR

intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%

Drug: Bupivacaine

Intrathecal Morphine

ACTIVE COMPARATOR

intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume

Drug: BupivacaineDrug: Morphine

Intrathecal Morphine-Dex

ACTIVE COMPARATOR

intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .

Drug: Dexmedetomidine (Precedex)Drug: BupivacaineDrug: Morphine

Interventions

Dexmedetomidine (Precedex)DRUG

intrathecal administration

Also known as: Precedex
Intrathecal Morphine-Dex
BupivacaineDRUG

intrathecal 10 mg bupivacaine

Also known as: Buvicaine
Intrathecal BupivacaineIntrathecal MorphineIntrathecal Morphine-Dex
MorphineDRUG

intrathecal 0.5mg morphine

Also known as: morphine sulphate
Intrathecal MorphineIntrathecal Morphine-Dex

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)

You may not qualify if:

  • known allergy to study drugs
  • Significant cardiac, respiratory, renal or hepatic disease.
  • nd or 3rd degree heart block.
  • Coagulation disorders.
  • Low back pain or other back problems.
  • Drug or alcohol abuse.
  • BMI\>30kg\\m2.
  • Psychiatric illnesses that would interfere with perception and assessment of pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abdel-Ghaffar HS, Mohamed SA, Fares KM. Combined Intrathecal Morphine and Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Major Abdominal Cancer Surgery. Pain Med. 2016 Nov;17(11):2109-2118. doi: 10.1093/pm/pnw031. Epub 2016 Mar 21.

    PMID: 27002003DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

DexmedetomidineBupivacaineMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Saher AB Mohamed, MD

    Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt

    STUDY DIRECTOR

  • Hala s Abdel-Ghaffar, MD

    Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt.

Study Record Dates

First Submitted

April 26, 2015

First Posted

May 6, 2015

Study Start

May 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05