Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery

NCT02410746 | Unknown DMC

• 1 other identifier: PECBLOCKV1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Post Operative

Keywords

pain; surgery

Outcome Measures

Primary Outcomes (1)

• targeted question as to which breast is more painful

  patient is asked which breast is more painful

  3 hours post-operatively

Secondary Outcomes (1)

• verbal numeric rating scale(VNRS)

  3 hours post-operatively

Study Arms (2)

standard chirocaine infiltration

ACTIVE COMPARATOR

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

Other: standard chirocaine infiltration; Other: standard post-operative analgesia

targeted chirocaine pec block

EXPERIMENTAL

pectoral muscle block with 10ml 0.25% chirocaine

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

Interventions

targeted chirocaine pec block OTHER

10ml 0.25% chirocaine in a specifically targeted in a nerve block

Also known as: Pectoral nerve block

targeted chirocaine pec block

standard chirocaine infiltration OTHER

10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion

Also known as: intra-operative analgesia

standard chirocaine infiltration

standard post-operative analgesia OTHER

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.

Also known as: Morphine, Paracetamol, ibuprofen, analgesia

standard chirocaine infiltration; targeted chirocaine pec block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Declining to give written consent.
• History of allergy to chirocaine local anaesthetic.
• Prior breast surgery.
• Chronic pain disorder.
• Significant medical co-morbidities.

Sponsors & Collaborators

• BMI Healthcare: lead

Study Sites (1)

Edgbaston BMI Hospital

Birmingham, West Midlands, B152QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Morphine; Acetaminophen; Ibuprofen; Analgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Anesthesia and Analgesia

Study Officials

• anne dancey, MBChB(hons)

  AAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Dancey, MBChB(Hons)

CONTACT

07808078276; annedancey@yahoo.co.uk

Louise Maclennan, MBChB

CONTACT

07738399472; leamaclennan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Plastic Surgeon

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 8, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)