USG PECS vs LIA for Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Procedure: USG PECS2 with Drug A (active)
* Procedure: USG PECS2 with Drug P (placebo)
* Procedure: Wound infiltration with Drug P (placebo)
* Procedure: Wound infiltration with Drug A (active)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-centre, prospective; double blinded randomised case control interventional study.Patients will be randomly allocated to group X or Y. Following anesthesia induction, all patients will receive USG modified Pecs2 blocks as described by Blanco et al with 30 mls of pharmacy prepared Drug A (active drug 0.25% levobupivacaine) or Drug P (placebo 0.9% NaCl), labelled PRE respectively based on the group allocation. After surgery, the surgeon shall infiltrate the wound with 30 mls of Drug P or Drug A respectively, labelled POST. Drug P has no active role in terms of outcomes being assessed in this study. Intraoperative analgesia will be provided by TCI Remifentanil. Following surgery, patients will be recovered by dedicated recovery nurses who will titrate intravenous morphine in the immediate postoperative period aiming to keep the NRS pain scores below 1.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group X<br>PECS group USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo) | Procedure: USG PECS2 with Drug A (active)<br>* Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine<br>Procedure: Wound infiltration with Drug P (placebo)<br>* Wound infiltration at the end of surgery with Drug P (0.9% saline)<br>|
| Active Comparator: Group Y<br>LA (local anaesthetic) infiltration group USG PECS2 with Drug P (placebo) Wound infiltration with Drug A (active) | Procedure: USG PECS2 with Drug P (placebo)<br>* Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)<br>Procedure: Wound infiltration with Drug A (active)<br>* Wound infiltration at the end of surgery with 0.25% levobupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption in Recovery | A measure of total amount in milligrams of morphine required in recovery | 24 hours | 
| Numeric Rating Scale (NRS) Pain scores | 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 | Measures Incidence and severity of postoperative nausea and vomiting before discharge from recovery Q1. Have you vomited or had dry retching? 0 No Once Twice 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 sometimes Often or most of the time 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 | Incidence of chronic post surgical pain following unilateral breast and axillary surgery for breast cancer | 1 year | 
| Cancer recurrence or metastasis | Incidence of cancer recurrence or new metastasis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, breast cancer analgesia, pecs2 blocks