None listed
Conditions
Brief summary
OBJECTIVES: To compare patient quality of recovery following breast surgery in those who receive pectoral nerve (Pecs) II blockade versus local anaesthetic infiltration by surgeons. DESIGN, SETTING, PARTICIPANTS: Prospective, triple-masked, randomised controlled trial of 104 female, adult, non-pregnant participants with an allocation ratio of 1:1. This will be conducted at St Vincent’s Hospital Melbourne and Peter MacCallum Cancer Centre. Recruitment of participants is planned from March 2016 to January 2018. Patients, investigators and all staff caring for patients and those making postoperative assessments will be blinded to group allocation. INTERVENTIONS: Patients will receive: a) Pecs II block and placebo surgical infiltration or b) Placebo Pecs II block and local anaesthetic surgical infiltration. Both will receive a standardised general anaesthetic and multimodal analgesia technique. MAIN OUTCOME MEASURES: The primary outcome measure will be patient quality of recovery (QoR) using the QoR-15 questionnaire at 24 hours. Secondary outcomes include assessment of pain related physical and functional interference using the Brief Pain Inventory three months post surgery and opioid consumption presented as oral morphine equivalent (OME) in the first 24 hour post-operative period.
Interventions
Ultrasound-guided pectoral nerve block (Pecs 2) with ropivacaine 0.475% 0.2ml/kg in the plane between pectoralis major and minor AND ropivacaine 0.475% 0.25ml/kg in the plane deep to pectoralis minor will be injected by anaesthetist prior to general anaesthesia, in addition to standardised general anaesthesia. Identical volume of 0.9% sodium chloride (normal saline) infiltrated subcutaneously by surgeons at wound edges prior to wound closure. Adherence is ensured by Pecs 2 block being performed
Ultrasound-guided pectoral nerve block (Pecs 2) with ropivacaine 0.475% 0.2ml/kg in the plane between pectoralis major and minor AND ropivacaine 0.475% 0.25ml/kg in the plane deep to pectoralis minor will be injected by anaesthetist prior to general anaesthesia, in addition to standardised general anaesthesia. Identical volume of 0.9% sodium chloride (normal saline) infiltrated subcutaneously by surgeons at wound edges prior to wound closure. Adherence is ensured by Pecs 2 block being performed by anaesthetists trained in Pecs 2 block. Surgeons will be notified of the protocol for wound infiltration.
Sponsors
Dr Gloria Seah
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adult female patients undergoing elective unilateral breast surgery [unilateral wide local excision WLE with or without sentinal lymph node biopsy, axillary clearance/dissection and unilateral mastectomy], American Society of Anesthesiologists (ASA) score I to III
Exclusion criteria
Male gender, body mass index > 45 kg/m2, perceived inability to complete study questionnaires (for example, non-native English speakers, cognitive impairment, psychiatric illness), body weight less than 50kg, significant renal or liver impairment, allergy to drugs used in the protocol, pregnancy, alcohol or drug abuse, opioid dependence and infection at the injection site.
Outcome results
None listed