USG PECS vs LIA for Breast Cancer Surgery

November 28, 2018 updated by: Shiva ARAVA, National Health Service, United Kingdom

Ultrasound Guided (USG) PECS Versus Local Infiltration Anaesthesia (LIA) for Breast Cancer Surgery - A Randomized Quadruple Blinded Efficacy and Safety Study

Breast cancer is the most common cancer for which women in the UK (United Kingdom) undergo surgery. A novel ultrasound guided regional anaesthetic technique called the 'Pecs 2' block has recently been described. This study compares ultrasound guided (USG) Pecs 2 block with local anaesthetic infiltration (LIA) for pain relief following breast cancer surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the commonest cancer in UK for which women undergo surgery. Pain relief for breast surgery may be either opioid/morphine based or regional or local anesthetic technique based. Both have specific advantages and disadvantages. Regional anesthesia is known to suppress the stress response to surgery by blocking noxious afferent neural input into the central nervous system. Locoregional anesthetic techniques offer excellent pain relief without the disadvantages of morphine.These include thoracic epidural anesthesia, paravertebral block, intercostal blocks and local anesthetic infiltration of the wound. More recently, a novel ultrasound guided interfascial nerve block technique the 'Pecs block' was proposed by Blanco et al which provides an alternative method of providing postoperative analgesia for breast surgery.There is also evidence, albeit limited to support use of local anesthetic infiltration in breast surgery, which is widely used for analgesia.

Currently, there are no large randomised control trials to prove the safety and efficacy of ultrasound guided Pecs blocks in breast surgery. Also, wound infiltration with local anesthetic is practiced widely and to date, there has been no study comparing local anesthetic wound infiltration with USG pecs blocks.

On this background, we intend to perform a prospective randomised double blinded trial to evaluate the efficacy and safety of ultrasound guided Pecs blocks for breast surgery by comparing it local anesthetic wound infiltration.

This is a single-centre, prospective, double blinded randomised case control interventional study. The study plans to enroll 110 participants.

Patients will be randomly allocated to either group X or Y using computer generated numbers. Standard monitoring as per AAGBI (Association of anesthetists of Great Britain and Ireland) guidelines will be instituted as per clinical requirement. All patients will be anaesthetized using total intravenous anesthesia using TCI (target controlled infusions) of propofol and remifentanil. Intraoperatively, propofol and remifentanil infusions shall be titrated by the anesthetist to maintain adequate depth of anesthesia and analgesia.

Following induction of anesthesia and before surgical incision, all patients will receive USG modified Pecs 2 blocks as described by Blanco et al with 30 mls of pharmacy prepared Drug A (containing active drug that is 0.25% levobupivacaine) or Drug P (containing placebo 0.9% NaCl), labelled "PRE" (pre-surgery) respectively based on the group to which they are allocated.

At the end of surgery, the surgeon shall infiltrate the wound with 30 mls of Drug P or Drug A respectively, labelled "POST". (post-surgery)

The anesthetist and surgeon doing the interventions will both be blinded as to the pharmacological contents of the drug. This will be done as previously mentioned with pharmacy labelling the drugs as "PRE" used for USG pecs block and "POST" for wound infiltration.

Also the observer, in this case the recovery nurse who will be titrating analgesia in the immediate postoperative period shall be blinded as to what group the patient belongs to. Intraoperative analgesia will be provided by TCI remifentanil. It shall be supplemented in all patients with intravenous paracetamol and parecoxib as part of a multimodal analgesic technique. Following completion of surgery, the patients will be recovered by two dedicated recovery nurses. The nurses will titrate intravenous morphine in the immediate postoperative period aiming to keep the NRS (Numerical rating Scale) pain scores below 1.

Observations will be made in the intraoperative & postoperative period looking at relevant outcome measures. Patients shall be followed up at 1h, 6h and 24 hrs to collect primary outcome measures. Secondary outcomes will be collected by telephonic follow up at 6 months and 12 month intervals following surgery.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Portadown, Northern Ireland, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult female breast cancer patients
  • Admitted to Craigavon Area Hospital
  • Requiring and undergoing elective/urgent unilateral breast surgery as set out in the protocol

Exclusion Criteria:

  • Patient allergic to local anaesthetic
  • Any condition precluding safe use of USG pecs blocks e.g. Infection at site, anatomical abnormality etc.
  • Preoperative chronic pain and or on pain medication over and above simple analgesics. Patients receiving any analgesia other than paracetamol, NSAIDS and codeine shall be excluded from the study.
  • Bilateral breast surgery
  • Consent declined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group X

PECS group

USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo)
Procedure: USG PECS2 with Drug A (active)
Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine
Procedure: Wound infiltration with Drug P (placebo)
Wound infiltration at the end of surgery with Drug P (0.9% saline)
Active Comparator: Group Y

LA (local anaesthetic) infiltration group

USG PECS2 with Drug P (placebo) Wound infiltration with Drug A (active)
Procedure: USG PECS2 with Drug P (placebo)
Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)
Procedure: Wound infiltration with Drug A (active)
Wound infiltration at the end of surgery with 0.25% levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption in Recovery
Time Frame: 24 hours
A measure of total amount in milligrams of morphine required in recovery
24 hours
Numeric Rating Scale (NRS) Pain scores
Time Frame: 24 hours
Self reported pain scores between 0-10 (0- no pain; 10- severe pain, as bad as can be) in recovery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV (Post operative nausea and vomiting) Impact Scale Score
Time Frame: 2 hours

Measures Incidence and severity of postoperative nausea and vomiting before discharge from recovery

Q1. Have you vomited or had dry retching?

0 No

  1. Once
  2. Twice
  3. Three or more times Q2. Have you experienced a feeling of nausea (an unsettled feeling in the stomach and a slight urge to vomit) If yes, has your feeling of nausea interfered with activities of daily living, such as being able to get out of bed, being able to move about freely in bed, being able to eat normally, or eating and drinking?

0 Not at all

  1. sometimes
  2. Often or most of the time
  3. All the time

To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score >5 defines clinically important PONV
2 hours
S -LANNS (Self- administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaire for chronic post surgical pain
Time Frame: 1 year
Incidence of chronic post surgical pain following unilateral breast and axillary surgery for breast cancer
1 year
Cancer recurrence or metastasis
Time Frame: 1 year
Incidence of cancer recurrence or new metastasis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Service, United Kingdom

Collaborators

Southern Health and Social Care Trust

Investigators

  • Principal Investigator: Shiva K Arava, MD,FRCA,EDRA, Craigavon Area Hospital, SHSCT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

November 25, 2018

Study Completion (Actual)

November 25, 2018

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST1516/35-193503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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