Pain, Post Operative Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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