Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery

July 23, 2016 updated by: Anne Dancey, BMI Healthcare

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B152QQ
        • Recruiting
        • Edgbaston BMI Hospital
        • Contact:
        • Contact:
          • Anne Dancey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: standard chirocaine infiltration
non-targeted infiltration of 10ml 0.25% Chirocaine into breast pocket
Other: standard chirocaine infiltration
10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion
Other Names:
  • intra-operative analgesia
Other: standard post-operative analgesia
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.
Other Names:
  • Morphine, Paracetamol, ibuprofen, analgesia
Experimental: targeted chirocaine pec block
pectoral muscle block with 10ml 0.25% chirocaine
Other: standard post-operative analgesia
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.
Other Names:
  • Morphine, Paracetamol, ibuprofen, analgesia
Other: targeted chirocaine pec block
10ml 0.25% chirocaine in a specifically targeted in a nerve block
Other Names:
  • Pectoral nerve block

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
targeted question as to which breast is more painful
Time Frame: 3 hours post-operatively
patient is asked which breast is more painful
3 hours post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
verbal numeric rating scale(VNRS)
Time Frame: 3 hours post-operatively
standard validated pain score
3 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BMI Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: anne dancey, MBChB(hons), Aas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PECBLOCKV1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

yes on individual request of the patient when study is completed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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