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

NCT03024697 | Completed Phase 4

• 1 other identifier: PECS 123
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast surgery; Pectoral plane block; PECs; Local anaesthesia infusion; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total postoperative opioid consumption

  Over first 24 postoperative hours

• 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

• 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

Study Arms (3)

PECs Block

ACTIVE COMPARATOR

Patients randomised to receive pectoral plane blocks and a sham local anaesthetic infusion wound catheter

Procedure: Pectoral Plane Block

LA Infusion

ACTIVE COMPARATOR

Patients randomised to receive a local anaesthetic infusion wound catheter; No sham pectoral plane block performed as patients usually under general anaesthetic at time of block.

Procedure: Local Anaesthetic Wound Infusion Catheter

PECs Block & LA Infusion

ACTIVE COMPARATOR

Patients randomised to receive pectoral plane blocks and a local anaesthetic infusion wound catheter.

Procedure: Pectoral Plane Block; Procedure: Local Anaesthetic Wound Infusion Catheter

Interventions

Pectoral Plane Block PROCEDURE

Also known as: PECs Block

PECs Block; PECs Block & LA Infusion

Local Anaesthetic Wound Infusion Catheter PROCEDURE

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

Also known as: Local Anaesthetic Infusion

LA Infusion; PECs Block & LA Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Undergoing breast surgery, including wide local excision (WLE) and sentinel lymph node biopsy (SLNB), mastectomy +- SLNB

You may not qualify if:

• 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

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (1)

Department of Anaesthesia, Mater Misericordiae University Hospital

Dublin, Ireland

Location

Related Publications (1)

• O'Scanaill P, Keane S, Wall V, Flood G, Buggy DJ. Single-shot pectoral plane (PECs I and PECs II) blocks versus continuous local anaesthetic infusion analgesia or both after non-ambulatory breast-cancer surgery: a prospective, randomised, double-blind trial. Br J Anaesth. 2018 Apr;120(4):846-853. doi: 10.1016/j.bja.2017.11.112. Epub 2018 Feb 14.

  PMID: 29576125 DERIVED

MeSH Terms

Conditions

Breast Diseases; Bites and Stings; Agnosia

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donal Buggy

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sean Keane; Anaesthesia SpR

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)