USG PECS vs LIA for Breast Cancer Surgery

NCT03555227 | Completed DMC

• 1 other identifier: ST1516/35-193503
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

breast cancer analgesia; pecs2 blocks; ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• PONV (Post operative nausea and vomiting) Impact Scale Score

  2 hours

• S -LANNS (Self- administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaire for chronic post surgical pain

  1 year

• Cancer recurrence or metastasis

  1 year

Study Arms (2)

Group X

ACTIVE COMPARATOR

PECS group USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo)

Procedure: USG PECS2 with Drug A (active); Procedure: Wound infiltration with Drug P (placebo)

Group Y

ACTIVE COMPARATOR

LA (local anaesthetic) infiltration group USG PECS2 with Drug P (placebo) Wound infiltration with Drug A (active)

Procedure: USG PECS2 with Drug P (placebo); Procedure: Wound infiltration with Drug A (active)

Interventions

USG PECS2 with Drug A (active) PROCEDURE

Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine

Group X

USG PECS2 with Drug P (placebo) PROCEDURE

Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)

Group Y

Wound infiltration with Drug P (placebo) PROCEDURE

Wound infiltration at the end of surgery with Drug P (0.9% saline)

Group X

Wound infiltration with Drug A (active) PROCEDURE

Wound infiltration at the end of surgery with 0.25% levobupivacaine

Group Y

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Only female participants
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Service, United Kingdom: lead
• Southern Health and Social Care Trust: collaborator

Study Sites (1)

Craigavon Area Hospital

Portadown, Northern Ireland, BT63 5QQ, United Kingdom

Location

Related Publications (19)

• 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.

  PMID: 9554895 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.

  PMID: 9804712 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.

  PMID: 11872051 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.

  PMID: 10070303 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.

  PMID: 17006061 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.

  PMID: 10825330 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.

  PMID: 7661350 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.

  PMID: 14649342 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.

  PMID: 10456819 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.

  PMID: 24617619 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.

  PMID: 24754798 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.

  PMID: 7487214 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.

  PMID: 17620838 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.

  PMID: 21831090 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.

  PMID: 22939099 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.

  PMID: 25376971 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.

  PMID: 22290456 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.

  PMID: 11323136 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.

  PMID: 15772908 BACKGROUND

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MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shiva K Arava, MD,FRCA,EDRA

  Craigavon Area Hospital, SHSCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Consultant Anaesthetist

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 13, 2018
• Study Start: September 25, 2017
• Primary Completion: November 25, 2018
• Study Completion: November 25, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

GB (1)