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Single-shot Pectoral Plane(PECs) Block Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECs Block and Local Anaesthetic Infusion After Breast Surgery: A Randomised, Double-blind, Non-inferiority Trial (NCT03024697)

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.
  • Procedure: Pectoral Plane Block
    • PECs Block
  • Procedure: Local Anaesthetic Wound Infusion Catheter
    Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter
    • Local Anaesthetic Infusion
Ages eligible for Study
18 Years and older
Genders eligible for Study
Female
Accepts Healthy Volunteers
No
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
Title; Single-shot pectoral plane(PECs) block versus continuous local anaesthetic infusion analgesia or both PECs block and local anaesthetic infusion after breast surgery: A randomised, double-blind, non-inferiority trial.

Background & Rationale; Pectoral Plane blocks (PECs) blocks I and II for chest wall anaesthesia and analgesia have recently been described and seem to be gaining in popularity. PECs blocks provide superior analgesia compared with placebo, and therefore reduce the need for opioid analgesia and related side-effects such as postoperative nausea and vomiting. However, there is a dearth of evidence based research for their efficacy, safety and cost compared with other effective, established chest wall analgesic techniques, such as paravertebral and local anaesthetic (LA) infusion pump analgesia. Therefore, the investigators propose a prospective, randomised, double-blind, non-inferiority trial to compare single shot PECs block versus continuous local anaesthetic pump analgesia versus combined PECs block and local anaesthetic pump analgesia.

Objectives & Endpoints; Primary End-Point: Area under curve of NRS (numerical rating score) pain score versus time, where NRS (on moving: sitting up in bed) are recorded at the following time points after surgery: 1 hr, 2-4 hr, 6-8 hr, 10-14 hr 20-24 hr.

Secondary end-points: Opioid consumption ovr 24 hr; Postoperative nausea, postoperative vomiting, sedation score, postural hypotension, estimated cost per patient. Chronic persistent breast pain at 3 months by telephone interview using Short Form McGill questionnaire.

Inclusion & Exclusion criteria - Covered in another section

Methodology - Covered in another section

Treatment of Study Subjects; Apart from the described interventions, no changes will be made to routine care for patients attending the Mater Misericordiae University Hospital (MMUH) for breast surgery

Safety Reporting; As each described intervention is a recognised technique for the provision of analgesia for patients undergoing breast surgery, no additional safety reporting measures will need to be put in place. Standard reporting of issues includes informing the supervising anaesthetist of pump malfunction, NRS pain score >4, signs of local anaesthetic toxicity and derangement of normal physiological parameters.

Proposed Statistical Analysis; Taking a NRS difference at any time point of 2 as being clinically important, studies based on opioid analgesia after breast surgery indicate a standard deviation (SD) of 2.5 as a reasonable median SD among NRS values in the early postoperative period. Therefore, taking a Type I error of 0.05 and a Type II error of 0.1, n=17 patients each group would be required to demonstrate this difference with 90% power. To allow for logistical difficulties in patient follow up, we propose to enrol n=20 patients in each arm of the study. Data will be inspected for distribution. Normally distributed data will be compared using unpaired independent sample t-test; non-parametric data will be compared using Mann Whitney or Kruskal Wallis test as appropriate.

Data Handling:

Data will be accessible by researchers only. Hard copy data will be recorded via means of a Data Record Form, which will subsequently be transferred to electronic format. Data will be coded in order to allow for double-blinding, and for patients to have the opportunity to withdraw consent to participate at any stage. The key to re-identify the data will be held by a secure third-party, and will not be released until all data analysis has been completed. Electronic data will be coded and stored in encrypted form on a password protected hospital computer, which is located in a locked office. Hard copy data will be coded and stored in a secure folder in a locked filing cabinet, which is located in a locked office. Data will not leave the site of origin at any stage.

Retention of Essential Documents; Coded data will be retained for the purposes of oral presentation and publication in a peer-reviewed journal. It will be retained for a period of time necessary to fulfil the purpose for which it was collected, after which point it will be destroyed. Data is strictly confidential, and will not be shared with third parties.

1 locations

Ireland (1)
  • Department of Anaesthesia, Mater Misericordiae University Hospital
    recruiting
    Dublin, Ireland
Status:
recruiting
Type:
Interventional
Phase:
Start:
31 October, 2016
Updated:
18 January, 2017
Participants:
60
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