Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03555227
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2018-05-18
Brief Title:
USG PECS vs LIA for Breast Cancer Surgery
Sponsor:
National Health Service United Kingdom
Organization:
National Health Service United Kingdom
Study Overview
Official Title:
Ultrasound Guided USG PECS Versus Local Infiltration Anaesthesia LIA for Breast Cancer Surgery - A Randomized Quadruple Blinded Efficacy and Safety Study
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
Breast cancer is the commonest cancer in UK for which women undergo surgery Pain relief for breast surgery may be either opioidmorphine 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 morphineThese 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 surgeryThere 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 025 levobupivacaine or Drug P containing placebo 09 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
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 025 levobupivacaine or Drug P containing placebo 09 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None