NCT02462577

Brief Summary

This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

May 28, 2015

Last Update Submit

December 29, 2015

Conditions

Acute PainChronic Pain

Keywords

Local morphinePostmastectomy pain

Outcome Measures

Primary Outcomes (1)

  • changes in acute pain intensity from the baseline

    Visual analogue pain scale score at rest (VAS-R) and during movement or ipsilateral arm abduction (VAS-M), will be assessed at the same points score ranging from 0 to 10 (zero = no pain and 10 = the worst pain imaginable).

    at 2,4,6,12,24,36 and 48 hour postoperatively

Secondary Outcomes (2)

  • Postoperative adverse effects

    2,4,6,12,24,36 and 48 hour postoperatively.

  • The probability of developing chronic neuropathic pain

    after one month and after two months postoperatively

Study Arms (4)

local instillation of morphine 5 mg

ACTIVE COMPARATOR

5 ml plain bupivacaine 0.5% and 5 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.

Drug: local instillation of morphine to surgical wound

local instillation of morphine 10 mg

ACTIVE COMPARATOR

5 ml plain bupivacaine 0.5% and 10 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.

Drug: local instillation of morphine to surgical wound

local instillation of morphine 15 mg

ACTIVE COMPARATOR

5 ml plain bupivacaine 0.5% and 15 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.

Drug: local instillation of morphine to surgical wound

local instillation of local anesthetics

PLACEBO COMPARATOR

5 ml plain bupivacaine 0.5% .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.

Drug: local instillation of morphine to surgical wound

Interventions

local instillation of morphine to surgical woundDRUG

comparison between different drug doses effects on pain

Also known as: morphine sulphate
local instillation of local anestheticslocal instillation of morphine 10 mglocal instillation of morphine 15 mglocal instillation of morphine 5 mg

Eligibility Criteria

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

You may qualify if:

  • female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection

You may not qualify if:

  • allergy to the study drugs
  • significant cardiac, respiratory, renal or hepatic disease
  • drug or alcohol abuse
  • psychiatric illness that would interfere with perception and assessment of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

Location

Related Publications (1)

  • Mohamed SA, Abdel-Ghaffar HS, Kamal SM, Fares KM, Hamza HM. Effect of Topical Morphine on Acute and Chronic Postmastectomy Pain: What Is the Optimum Dose? Reg Anesth Pain Med. 2016 Nov/Dec;41(6):704-710. doi: 10.1097/AAP.0000000000000496.

    PMID: 27755490DERIVED

MeSH Terms

Conditions

Acute PainChronic Pain

Interventions

Morphine

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 Compounds

Study Officials

  • Shereen M Mohamed, MD

    Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia,ICU and pain relief

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 4, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

EG(1)