NCT03063671

Brief Summary

This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

February 21, 2017

Last Update Submit

June 27, 2019

Conditions

Acute Pain

Keywords

postmastectomy pain

Outcome Measures

Primary Outcomes (1)

  • total dose of intravenous morphine consumption in the first 48 hours post operatively

    total dose of intravenous morphine comsumption

    48 hours postoperative

Secondary Outcomes (4)

  • Visual analogue scale

    0, 2,4,6,8,18,36,48 hours

  • MAP

    0,30,60,120,150 minutes

  • HR

    0,30,60,120,150 minutes

  • sedation score

    0, 2,4,6,8,18,36,48 hours

Study Arms (4)

bupivacine group

ACTIVE COMPARATOR

preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% as one shot 15 minutes before general anesthesia postoperative analgesia done by infusion of bupivacaine 0.125% (5ml/hour through thoracic epidural catheter for 12 hours).

Drug: Ketamine, bupivacine,dexmedetomidine

ketamine group

ACTIVE COMPARATOR

preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus ketamine in a dose 0.5 mg/kg 15 minutes before general anesthesia postoperative analgesia will be preformed by infusion of mixture of (bupivacaine 0.125% plus ketamine 0.5 mg/ml ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours

Drug: Ketamine, bupivacine,dexmedetomidine

dexmedetomidine group

ACTIVE COMPARATOR

preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus dexmedetomidine in a dose 1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours.

Drug: Ketamine, bupivacine,dexmedetomidine

ketamine-dexmedetomidine group

ACTIVE COMPARATOR

preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus both ketamine in a dose 0.3 mg/kg and dexmedetomidine in a dose 0.1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml and and ketamine 0.5 mg/ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours.

Drug: Ketamine, bupivacine,dexmedetomidine

Interventions

Ketamine, bupivacine,dexmedetomidineDRUG

thoracic epidural catheter insertion at T4-5

bupivacine groupdexmedetomidine groupketamine groupketamine-dexmedetomidine group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for modified radical mastectomy.
  • ASA Physical status I, II and III.

You may not qualify if:

  • Patients' refusal.
  • Uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (VAS).
  • Patients with history of drug allergy.
  • severe renal or liver impairment, unstable ischemic heart disease
  • Any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

south Egypt cancer institute

Asyut, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

KetamineDexmedetomidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
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
lectruer

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

April 1, 2018

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

EG(1)