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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 Prospective Randomised, Double-blind Trial

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ClinicalTrials.gov Identifier: NCT03024697
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Keane, Mater Misericordiae University Hospital

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.


Condition or disease Intervention/treatment Phase
Breast Diseases Anesthesia Block Procedure: Pectoral Plane Block Procedure: Local Anaesthetic Wound Infusion Catheter Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PECs Block
Patients randomised to receive pectoral plane blocks and a sham local anaesthetic infusion wound catheter
Procedure: Pectoral Plane Block
Other Name: PECs Block

Active Comparator: LA Infusion
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
Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter
Other Name: Local Anaesthetic Infusion

Active Comparator: PECs Block & LA Infusion
Patients randomised to receive pectoral plane blocks and a local anaesthetic infusion wound catheter.
Procedure: Pectoral Plane Block
Other Name: PECs Block

Procedure: Local Anaesthetic Wound Infusion Catheter
Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter
Other Name: Local Anaesthetic Infusion




Primary Outcome Measures :
  1. Area under curve of verbal rating score (VRS) of pain moving versus time [ Time Frame: VRS pain was measured at 1 hour, 4-6 hours, 10-14 hours, and 20-24 hours postoperatively ]

Secondary Outcome Measures :
  1. Total postoperative opioid consumption [ Time Frame: Over first 24 postoperative hours ]
  2. Postoperative nausea and vomiting [ Time Frame: Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours ]
  3. Postoperative sedation score [ Time Frame: Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024697


Locations
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Ireland
Department of Anaesthesia, Mater Misericordiae University Hospital
Dublin, Ireland
Sponsors and Collaborators
Mater Misericordiae University Hospital
Investigators
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Principal Investigator: Donal Buggy Mater Misericordiae University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sean Keane, Dr. Sean Keane; Anaesthesia SpR, Mater Misericordiae University Hospital
ClinicalTrials.gov Identifier: NCT03024697    
Other Study ID Numbers: PECS 123
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to other researchers as this has been pre-determined with patients as part of the process of informed consent.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Keane, Mater Misericordiae University Hospital:
Breast surgery
Pectoral plane block
PECs
Local anaesthesia infusion
Analgesia
Additional relevant MeSH terms:
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Breast Diseases
Skin Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents