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Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery

Primary Purpose

Pain, Post Operative

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
targeted chirocaine pec block
standard chirocaine infiltration
standard post-operative analgesia
Sponsored by
BMI Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Post Operative focused on measuring pain, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Edgbaston BMI HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard chirocaine infiltration

targeted chirocaine pec block

Arm Description

non-targeted infiltration of 10ml 0.25% Chirocaine into breast pocket

pectoral muscle block with 10ml 0.25% chirocaine

Outcomes

Primary Outcome Measures

targeted question as to which breast is more painful
patient is asked which breast is more painful

Secondary Outcome Measures

verbal numeric rating scale(VNRS)
standard validated pain score

Full Information

First Posted
March 31, 2015
Last Updated
July 23, 2016
Sponsor
BMI Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02410746
Brief Title
Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery
Official Title
A Prospective, Randomised Double Blinded Study Comparing a Pectoral Nerve Block With Non-targeted Local Anaesthetic in Bilateral Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BMI Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effective postoperative pain control is an essential component of surgery. Adequate analgesia improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster recovery and less likelihood of complications.The majority of surgeons will place 10ml of local anaesthetic into the breast pocket or inject it into the breast skin following breast surgery. A more specific technique is to identify the nerves supplying the breast and put the local anaesthetic directly around them (Pec block). This nerve block has recently been described and is increasingly being used by anaesthetists for surgery under local anaesthetic or for post-operative analgesia. It has been shown to provide better and more specific pain relief in several studies. Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves and they inject into the vicinity. They do not have direct vision and there is a risk of causing morbidity or the block not being effective. It is much easier for a surgeon to apply the block, as they can see the anatomical landmarks. Despite this, very few surgeons are aware of the technique. The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and Worcester. If a patient consents to being involved in the research, they will have one breast randomised to receiving a pec block and the contralateral (opposite) breast will receive the same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The patients and researcher will be blinded as to the allocation. Patients will complete a verbal numeric pain score for each breast at set intervals until they are discharged.In addition, the investigators will specifically ask which breast is the most painful at each time point. The results of the study may improve patient care.
Detailed Description
The investigators' intention is to randomise all patients undergoing bilateral breast surgery into receiving a specific pec block in one breast and a standard infiltration of non targeted anaesthesia into the other breast. 10ml 0.25% Chirocaine will be used for each breast. All patients attending the plastic surgery clinic at BMI Edgbaston, BMI Priory, Spire Parkway and Spire Southbank and requesting bilateral breast surgery will be approached to take part in the study. They will be given information to take home and an opportunity to ask any questions about the study. All consenting patients who meet the inclusion criteria will have one breast randomised into a study group (pec block) and the other into a control group (standard local anaesthetic infiltration). Patients will be randomised by a computer generated code. The patient and researcher will be blinded. By necessity, the surgeon will be aware of the randomisation but will have no involvement in data collection or analysis of results. Both groups will receive standard post-operative care and follow up. A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen. The investigators will prospectively record post operative pain as rated by a verbal numerical rating scale at 0, 3, 6, 9 and 12 hours post-operatively and at 24 hours. In addition the investigators will record which breast the patient indicates is the most painful and any post-operative complications throughout the study period . The expected recruitment period is six months. If patients consent to inclusion in the study they will sign a consent form at a second appointment or on the day of surgery. The ward and recovery nurses already have experience in administering a VNRS for pain control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative
Keywords
pain, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard chirocaine infiltration
Arm Type
Active Comparator
Arm Description
non-targeted infiltration of 10ml 0.25% Chirocaine into breast pocket
Arm Title
targeted chirocaine pec block
Arm Type
Experimental
Arm Description
pectoral muscle block with 10ml 0.25% chirocaine
Intervention Type
Other
Intervention Name(s)
targeted chirocaine pec block
Other Intervention Name(s)
Pectoral nerve block
Intervention Description
10ml 0.25% chirocaine in a specifically targeted in a nerve block
Intervention Type
Other
Intervention Name(s)
standard chirocaine infiltration
Other Intervention Name(s)
intra-operative analgesia
Intervention Description
10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion
Intervention Type
Other
Intervention Name(s)
standard post-operative analgesia
Other Intervention Name(s)
Morphine, Paracetamol, ibuprofen, analgesia
Intervention Description
A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen.
Primary Outcome Measure Information:
Title
targeted question as to which breast is more painful
Description
patient is asked which breast is more painful
Time Frame
3 hours post-operatively
Secondary Outcome Measure Information:
Title
verbal numeric rating scale(VNRS)
Description
standard validated pain score
Time Frame
3 hours post-operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Dancey, MBChB(Hons)
Phone
07808078276
Email
annedancey@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Maclennan, MBChB
Phone
07738399472
Email
leamaclennan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anne dancey, MBChB(hons)
Organizational Affiliation
AAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edgbaston BMI Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B152QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Dancey, FRCS(Plast)
Phone
07808078276
Email
anne@annedancey.co.uk
First Name & Middle Initial & Last Name & Degree
Anne Dancey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
yes on individual request of the patient when study is completed

Learn more about this trial

Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery

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