Anesthesia Clinical Trial
Official title:
Single-shot Pectoral Plane (PECs) Blocks Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECs Block and Local Anaesthetic Infusion After Non-ambulatory Breast Cancer Surgery: A Prospective, Randomised, Double-blind Trial
Verified date | September 2017 |
Source | Mater Misericordiae University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this proposed study, the investigators are looking to conduct a prospective, randomised,
double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks versus
continuous local anaesthetic infusion analgesia versus a combination of PECs blocks and local
anaesthetic infusion analgesia, when it comes to providing analgesia for most forms of breast
surgery.
Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques
involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are
growing in popularity, as they reduce the amount of opioid medications used. Opioids are
associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as
such, opioid-sparing analgesic regimens postoperatively are becoming more common. These
regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug),
and a local anaesthetic technique.
Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations
within the chest wall, typically done after the patient undergoes general anaesthesia, but
before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion of
a catheter into the wound at the end of surgery, before the patient emerges from general
anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each
technique is considered extremely safe, and is considered acceptable as a form of pain relief
in patients undergoing breast surgery.
There are no published works comparing pectoral plane blocks with local anaesthetic infusion
pump analgesia, and the investigators see a gap in the knowledge base that can be addressed.
This study will allow efficacy, safety and cost of the three techniques to be compared. The
investigators feel the study design is robust, and statistical analysis based on previously
published works in the area of postoperative analgesia has allowed the study to be powered
appropriately.
Patients undergoing breast surgery are a vulnerable group, and this is recognised via the
provision of a comprehensive Patient Information Leaflet and a commitment to respecting the
process of Informed Consent. The investigators also recognise this is a stressful period in a
woman's life, and the study will be conducted in a sensitive and compassionate manner.
The study has been designed to be prospective, randomised, and double-blinded. The
anaesthetic will be standardised in relation to analgesic and anti-emetic agents
administered, in order to minimise variables. Chronic post-surgical pain is a growing area of
research, and the follow-up telephone interview at 3-months will allow investigation of this.
A Data Record Form will be utilised for data collection, which will subsequently be analysed
statistically. Data will be handled sensitively, securely, and by the minimum number of
researchers. A plan is in place for destruction of data at an appropriate time.
While there will be no direct benefit to participants, including monetary considerations,
this research study will add to the knowledge-base surrounding analgesia for breast surgery.
Status | Completed |
Enrollment | 45 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Undergoing breast surgery, including wide local excision (WLE) and sentinel lymph node biopsy (SLNB), mastectomy +- SLNB Exclusion Criteria: - Male - Undergoing flap reconstruction breast surgery, implant surgery or bilateral breast surgery - Chronic pain syndrome - Local anaesthetic allergy - Contraindication to routine postoperative analgesia, e.g. paracetamol - Contraindication to regional anaesthesia, i.e. localised infection |
Country | Name | City | State |
---|---|---|---|
Ireland | Department of Anaesthesia, Mater Misericordiae University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Mater Misericordiae University Hospital |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under curve of verbal rating score (VRS) of pain moving versus time | VRS pain was measured at 1 hour, 4-6 hours, 10-14 hours, and 20-24 hours postoperatively | ||
Secondary | Total postoperative opioid consumption | Over first 24 postoperative hours | ||
Secondary | Postoperative nausea and vomiting | Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours | ||
Secondary | Postoperative sedation score | Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours |
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