NCT02935933

Brief Summary

Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could improve the analgesic effect and thus reduce postoperative morphine consumption and development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast conservation surgery with axillary lymph node dissection.

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
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

October 12, 2016

Last Update Submit

January 10, 2018

Conditions

Acute PainChronic Pain

Outcome Measures

Primary Outcomes (1)

  • total dose of morphine consumption

    the total dose of morphine consumption

    48 hours

Secondary Outcomes (2)

  • visual analouge scale

    0 (immediately after recovery from anesthesia), 2,4,6,12,24,36 and 48 hour postoperatively

  • chronic postmastectomy pain

    1,2,3 months

Study Arms (3)

Paravertebral block with bupivacaine

ACTIVE COMPARATOR

patients received 20 ml of bupivacaine 0.25% paravertebrally in 3 levels, divided into 6-7 ml in each level

Drug: bupivicaine

Paravertebral block with bupivacaine + morphine

ACTIVE COMPARATOR

patients received 20 ml of bupivacaine 0.25% +5 mg morphine paravertebrally in 3 levels, divided into 6-7 ml in each level.

Drug: bupivicaineDrug: morphine

Paravertebral block with bupivacaine + dexmedetomidine

ACTIVE COMPARATOR

patients received 20 ml of bupivacaine 0.25% + 1 μg/kg dexmedetomidine paravertebrally in 3 levels divided into 6-7 ml in each level.

Drug: bupivicaineDrug: Dexmedetomidine

Interventions

bupivicaineDRUG

Paravertebral block

Paravertebral block with bupivacaineParavertebral block with bupivacaine + dexmedetomidineParavertebral block with bupivacaine + morphine
morphineDRUG
Paravertebral block with bupivacaine + morphine
DexmedetomidineDRUG
Paravertebral block with bupivacaine + dexmedetomidine

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physical status classes I to III ( weight 50 - 85 kg), will be scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation will be consecutively enrolled.

You may not qualify if:

  • patient refusal,
  • patients with a known allergy to investigated drugs,
  • bleeding disorders,
  • anatomical abnormalities,
  • infection in the paravertebral region,
  • pregnancy, breast feeding,
  • a history of drug or alcohol abuse, and patients with chronic pain or regularly receiving analgesics.
  • patients subjected for bilateral mastectomy or any unilateral breast surgery other than MRM with axillary evacuation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Iorg0006563, 171516, Egypt

Location

MeSH Terms

Conditions

Acute PainChronic Pain

Interventions

MorphineDexmedetomidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

June 1, 2018

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)