Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
110 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-25
Study Completion Date
2018-11-25
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.
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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.
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.
Conditions
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Breast Cancer Female
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
All patients will be receiving both interventions i.e. USG PECS blocks and wound infiltration anesthesia, with local anesthetic 0.25% levobupivacaine (active) and 0.9% Saline depending on the randomized group allocations. As such patients will be blinded.The anaesthetist and surgeon doing the interventions will both be blinded as to the pharmacological contents of the drug. This will be done as 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.
Study Groups
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Group X
PECS group
USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo)
Group Type
ACTIVE_COMPARATOR
USG PECS2 with Drug A (active)
Intervention Type
PROCEDURE
Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine
Wound infiltration with Drug P (placebo)
Intervention Type
PROCEDURE
Wound infiltration at the end of surgery with Drug P (0.9% saline)
Group Y
LA (local anaesthetic) infiltration group
USG PECS2 with Drug P (placebo) Wound infiltration with Drug A (active)
Group Type
ACTIVE_COMPARATOR
USG PECS2 with Drug P (placebo)
Intervention Type
PROCEDURE
Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)
Wound infiltration with Drug A (active)
Intervention Type
PROCEDURE
Wound infiltration at the end of surgery with 0.25% levobupivacaine
Interventions
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USG PECS2 with Drug A (active)
Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine
Intervention Type
PROCEDURE
USG PECS2 with Drug P (placebo)
Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)
Intervention Type
PROCEDURE
Wound infiltration with Drug P (placebo)
Wound infiltration at the end of surgery with Drug P (0.9% saline)
Intervention Type
PROCEDURE
Wound infiltration with Drug A (active)
Wound infiltration at the end of surgery with 0.25% levobupivacaine
Intervention Type
PROCEDURE
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
* 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
* 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
Minimum Eligible Age
16 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Southern Health and Social Care Trust
OTHER_GOV
Sponsor Role
collaborator
National Health Service, United Kingdom
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Shiva ARAVA
Doctor, Consultant Anaesthetist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shiva K Arava, MD,FRCA,EDRA
Role: PRINCIPAL_INVESTIGATOR
Craigavon Area Hospital, SHSCT
Locations
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Craigavon Area Hospital
Portadown, Northern Ireland, United Kingdom
Site Status
Countries
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United Kingdom
References
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Bonnema J, van Wersch AM, van Geel AN, Pruyn JF, Schmitz PI, Paul MA, Wiggers T. Medical and psychosocial effects of early discharge after surgery for breast cancer: randomised trial. BMJ. 1998 Apr 25;316(7140):1267-71. doi: 10.1136/bmj.316.7140.1267.
Reference Type
BACKGROUND
Bundred N, Maguire P, Reynolds J, Grimshaw J, Morris J, Thomson L, Barr L, Baildam A. Randomised controlled trial of effects of early discharge after surgery for breast cancer. BMJ. 1998 Nov 7;317(7168):1275-9. doi: 10.1136/bmj.317.7168.1275.
Reference Type
BACKGROUND
Purushotham AD, McLatchie E, Young D, George WD, Stallard S, Doughty J, Brown DC, Farish C, Walker A, Millar K, Murray G. Randomized clinical trial of no wound drains and early discharge in the treatment of women with breast cancer. Br J Surg. 2002 Mar;89(3):286-92. doi: 10.1046/j.0007-1323.2001.02031.x.
Reference Type
BACKGROUND
Bonnema J, van Wersch AM, van Geel AN, Pruyn JF, Schmitz PI, Uyl-de Groot CA, Wiggers T. Cost of care in a randomised trial of early hospital discharge after surgery for breast cancer. Eur J Cancer. 1998 Dec;34(13):2015-20. doi: 10.1016/s0959-8049(98)00258-5.
Reference Type
BACKGROUND
Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. doi: 10.1097/00000542-200610000-00008.
Reference Type
BACKGROUND
Sacerdote P, Bianchi M, Gaspani L, Manfredi B, Maucione A, Terno G, Ammatuna M, Panerai AE. The effects of tramadol and morphine on immune responses and pain after surgery in cancer patients. Anesth Analg. 2000 Jun;90(6):1411-4. doi: 10.1097/00000539-200006000-00028.
Reference Type
BACKGROUND
Yeager MP, Colacchio TA, Yu CT, Hildebrandt L, Howell AL, Weiss J, Guyre PM. Morphine inhibits spontaneous and cytokine-enhanced natural killer cell cytotoxicity in volunteers. Anesthesiology. 1995 Sep;83(3):500-8. doi: 10.1097/00000542-199509000-00008.
Reference Type
BACKGROUND
Naja MZ, Ziade MF, Lonnqvist PA. Nerve-stimulator guided paravertebral blockade vs. general anaesthesia for breast surgery: a prospective randomized trial. Eur J Anaesthesiol. 2003 Nov;20(11):897-903. doi: 10.1017/s0265021503001443.
Reference Type
BACKGROUND
Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4. doi: 10.1034/j.1399-6576.1999.430714.x.
Reference Type
BACKGROUND
Byager N, Hansen MS, Mathiesen O, Dahl JB. The analgesic effect of wound infiltration with local anaesthetics after breast surgery: a qualitative systematic review. Acta Anaesthesiol Scand. 2014 Apr;58(4):402-10. doi: 10.1111/aas.12287.
Reference Type
BACKGROUND
Campbell I, Cavanagh S, Creighton J, French R, Banerjee S, Kerr E, Shirley R. To infiltrate or not? Acute effects of local anaesthetic in breast surgery. ANZ J Surg. 2015 May;85(5):353-7. doi: 10.1111/ans.12541. Epub 2014 Apr 22.
Reference Type
BACKGROUND
Lynch EP, Welch KJ, Carabuena JM, Eberlein TJ. Thoracic epidural anesthesia improves outcome after breast surgery. Ann Surg. 1995 Nov;222(5):663-9. doi: 10.1097/00000658-199511000-00009.
Reference Type
BACKGROUND
Vila H Jr, Liu J, Kavasmaneck D. Paravertebral block: new benefits from an old procedure. Curr Opin Anaesthesiol. 2007 Aug;20(4):316-8. doi: 10.1097/ACO.0b013e328166780e.
Reference Type
BACKGROUND
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Reference Type
BACKGROUND
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
Reference Type
BACKGROUND
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Reference Type
BACKGROUND
Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
Reference Type
BACKGROUND
Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
Reference Type
BACKGROUND
Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
Reference Type
BACKGROUND
Related Links
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Other Identifiers
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ST1516/35-193503
Identifier Type: -
Identifier Source: org_study_id
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