NCT02462681

Brief Summary

This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

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

May 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

May 30, 2015

Last Update Submit

June 29, 2017

Conditions

Acute PainChronic Pain

Keywords

ketamineadjuvantparavertebral block

Outcome Measures

Primary Outcomes (1)

  • changes in pain intensity score from baseline

    Visual analogue scale (VAS) Scored from 0-10 (where 0= no pain and 10= the worst pain imaginable) as it measured as VAS at rest (VAS.R) and during movement or ipsilateral arm abduction (VAS.M)

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

Secondary Outcomes (2)

  • side effect

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

  • chronic neuropathic pain

    1st,2nd and 3rd postoperative months

Study Arms (3)

bupivacaine group in paravertebral block

ACTIVE COMPARATOR

patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level

Drug: paravertebral block

bupivacaine + 0.5 mg/kg ketamine group in paravertebral block

ACTIVE COMPARATOR

patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level

Drug: paravertebral block

bupivacaine + 1 mg/kg ketamine group in paravertebral block

ACTIVE COMPARATOR

patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level

Drug: paravertebral block

Interventions

paravertebral blockDRUG

Thoracic paravertebral blocks will be performed as described by Moore and Katz. Intradermal lidocaine will be used at the site of the needle insertion. The superior aspect of the spinous processes of T1- T6 will be marked. The skin entry points will 3 cm laterals to the marks. A 22- gauge quincke spinal needle attach to extension tubing to a syringe containing study drugs will be used. The needle will be inserted perpendicular to the skin for a distance of 2 to 4 cm until the transverse process will contact. The needle will be withdrawn and walk cephalad off the transverse process and advance for a further 1.5 to 2 cm.

Also known as: ketamine hydrochloride
bupivacaine + 0.5 mg/kg ketamine group in paravertebral blockbupivacaine + 1 mg/kg ketamine group in paravertebral blockbupivacaine group in paravertebral block

Eligibility Criteria

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

You may qualify if:

  • all patients scheduled for elective modified radical mastectomy with axillary dissection will be enrolled in the study

You may not qualify if:

  • patients with a known allergy to the study drugs
  • patients with bleeding diathesis
  • patients with infection at the site of injection
  • patients with central neuropathy
  • patients with liver impairment
  • patients with renal impairment
  • drugs or alcohol abusers
  • patients with psychiatric illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Acute PainChronic Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sahar A. Mohamed, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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 30, 2015

First Posted

June 4, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

EG(1)