Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

BMI Healthcare

Recruitment countries:

United Kingdom

Health condition studied:

Pain, Post Operative

URL:

Link to the clinical trial website

About the trial

Interventions:

Other: standard chirocaine infiltration
Other: standard post-operative analgesia
Other: targeted chirocaine pec block

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Patient requesting a bilateral breast procedure (reduction, mastopexy or
  augmentation).
  
  - Patient willing to sign the informed consent form agreeing to its items after
  explanation of the study by the operating surgeon.
  
  Exclusion Criteria:
  
  - Declining to give written consent.
  
  - History of allergy to chirocaine local anaesthetic.
  
  - Prior breast surgery.
  
  - Chronic pain disorder.
  
  - Significant medical co-morbidities.
  

• Age minimum:  18 Years
• Age maximum:  N/A
• Gender:  Female

Primary outcomes:

targeted question as to which breast is more painful

Secondary outcomes:

verbal numeric rating scale(VNRS)

Target sample size:

50

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name:   Anne Dancey, FRCS(Plast)
• Address: 
• Phone:  07808078276
• Email:  anne@annedancey.co.uk
• Affiliation: 

• Name:   anne dancey, MBChB(hons)
• Address: 
• Phone: 
• Email: 
• Affiliation:  AAS

• Name:   Anne Dancey, MBChB(Hons)
• Address: 
• Phone:  07808078276
• Email:  annedancey@yahoo.co.uk
• Affiliation: 

Technical details

Scientific title:

A Prospective, Randomised Double Blinded Study Comparing a Pectoral Nerve Block With Non-targeted Local Anaesthetic in Bilateral Breast Surgery

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02410746

Secondary ID:

PECBLOCKV1

Register:

ClinicalTrials.gov

Date of registration:

31/03/2015

Date of first enrollment:

January 2016

Last refreshed:

8 August 2016