NCT03204708

Brief Summary

patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

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

April 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

May 22, 2017

Last Update Submit

February 12, 2018

Conditions

Mammary Cancer

Keywords

postoperative analgsiaperipheral block cathetermodified radical mastectomy

Outcome Measures

Primary Outcomes (4)

  • VAS scores

    patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

    1 hour after operation

  • VAS scores

    patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

    6 hours after operation

  • VAS scores

    patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

    12 hours after operation

  • VAS scores

    patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

    24 hours after operation

Secondary Outcomes (1)

  • VAS scores

    3 months after operation

Other Outcomes (1)

  • rescue analgesic requirement

    1, 6, 12 and 24 hours after operation

Study Arms (2)

iv analgesia

ACTIVE COMPARATOR

patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.

Device: catheterDrug: iv analgesia

catheter group

ACTIVE COMPARATOR

patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia

Device: catheterDrug: iv analgesia

Interventions

catheterDEVICE

catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis

catheter groupiv analgesia
iv analgesiaDRUG

patients were given 100 ml of tramadol 30 minutes before extubation

catheter groupiv analgesia

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Americans Class I-II

You may not qualify if:

  • male
  • allergy to local anesthetics or
  • anticoagulant drug use
  • central or peripheric nerve disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CathetersAnalgesia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and SuppliesAnesthesia and Analgesia

Study Officials

  • cigdem akyol beyoglu, MD

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 22, 2017

First Posted

July 2, 2017

Study Start

April 15, 2016

Primary Completion

February 15, 2017

Study Completion

February 28, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share