Single-shot Pectoral Plane(PECs) Block Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECS Block and Local Anaesthetic Infusion After Breast Surgery: A Prospective Randomised, Double-blind Trial

Summary

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.

Conditions

• Breast Diseases
• Anesthesia
• Block

Interventions

PROCEDURE

Pectoral Plane Block

PROCEDURE

Local Anaesthetic Wound Infusion Catheter

Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter

Sponsors & Collaborators

• Mater Misericordiae University Hospital

  lead OTHER

Principal Investigators

• Donal Buggy · Mater Misericordiae University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• Ireland

Study Locations