Breast Cancer FemaleNCT03555227
USG PECS vs LIA for Breast Cancer Surgery
A study testing USG PECS2 with Drug A (active) and Wound infiltration with Drug A (active) in people with Breast Cancer Female, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- USG PECS2 with Drug A (active) and Wound infiltration with Drug A (active)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2017to 25 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult female breast cancer patients
- Admitted to Craigavon Area Hospital
- Requiring and undergoing elective/urgent unilateral breast surgery as set out in the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Craigavon Area Hospital
Portadown, Northern Ireland, BT63 5QQ
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- USG PECS2 with Drug A (active), USG PECS2 with Drug P (placebo), Wound infiltration with Drug P (placebo), Wound infiltration with Drug A (active)
- Keywords
- breast cancer analgesia, pecs2 blocks, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG PECS2 with Drug A (active)Procedure or surgery
Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine
USG PECS2 with Drug P (placebo)Procedure or surgery
Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)
Wound infiltration with Drug P (placebo)Procedure or surgery
Wound infiltration at the end of surgery with Drug P (0.9% saline)
Wound infiltration with Drug A (active)Procedure or surgery
Wound infiltration at the end of surgery with 0.25% levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group X | Active comparator | PECS group
USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo) Receives: 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) Receives: Procedure: USG PECS2 with Drug P (placebo); Procedure: Wound infiltration with Drug A (active) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in Recovery
A measure of total amount in milligrams of morphine required in recovery
Measured: 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
Measured: 24 hours
Secondary outcomes (3)
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
Measured: 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
Measured: 1 year
Cancer recurrence or metastasis
Incidence of cancer recurrence or new metastasis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start25 Sep 2017
- Primary completion25 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Collaborators
- Southern Health and Social Care Trust
- Responsible party
- Principal investigator, Shiva ARAVA, National Health Service, United Kingdom
- Investigators
- Shiva K Arava, MD,FRCA,EDRA, Principal investigator, Craigavon Area Hospital, SHSCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555227
- Sponsor's protocol ID
- ST1516/35-193503
- Status last verified
- Nov 2018
- First submitted
- 18 May 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9554895Bundred 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.
PubMed 9804712Purushotham 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.
PubMed 11872051Bonnema 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.
PubMed 10070303Exadaktylos 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.
PubMed 17006061Sacerdote 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.
PubMed 10825330Yeager 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.
PubMed 7661350Naja 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.
PubMed 14649342Pusch 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.
PubMed 10456819Byager 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.
PubMed 24617619Campbell 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.
PubMed 24754798Lynch 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.
PubMed 7487214Vila 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.
PubMed 17620838Blanco 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.
PubMed 21831090Blanco 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.
PubMed 22939099
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided (USG) PECS Versus Local Infiltration Anaesthesia (LIA) for Breast Cancer Surgery - A Randomized Quadruple Blinded Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT03555227
- Acronym / sponsor ID
- ST1516/35-193503
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer analgesia, pecs2 blocks, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Health Service, United KingdomOther government
- Collaborators
- Southern Health and Social Care Trust
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group X | Active comparator | Procedure: USG PECS2 with Drug A (active), Procedure: Wound infiltration with Drug P (placebo)PECS group USG PECS2 with Drug A (active) Wound infiltration with Drug P (placebo) |
| Group Y | Active comparator | Procedure: USG PECS2 with Drug P (placebo), Procedure: Wound infiltration with Drug A (active)LA (local anaesthetic) infiltration group USG PECS2 with Drug P (placebo) Wound infiltration with Drug A (active) |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult female breast cancer patients
- Admitted to Craigavon Area Hospital
- Requiring and undergoing elective/urgent unilateral breast surgery as set out in the protocol
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG PECS2 with Drug A (active)Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine | Procedure or surgery | Group X |
| USG PECS2 with Drug P (placebo)Ultrasound guided Pecs 2 blocks with placebo (0.9% saline) | Procedure or surgery | Group Y |
| Wound infiltration with Drug P (placebo)Wound infiltration at the end of surgery with Drug P (0.9% saline) | Procedure or surgery | Group X |
| Wound infiltration with Drug A (active)Wound infiltration at the end of surgery with 0.25% levobupivacaine | Procedure or surgery | Group Y |
Primary outcome
Morphine consumption in Recovery
Time frame: 24 hours
A measure of total amount in milligrams of morphine required in recovery
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
3 secondary outcomes
PONV (Post operative nausea and vomiting) Impact Scale Score
Time frame: 2 hours
S -LANNS (Self- administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaire for chronic post surgical pain
Time frame: 1 year
Cancer recurrence or metastasis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Background: PubMed 9554895Bonnema 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.
- Background: PubMed 9804712Bundred 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.
- Background: PubMed 11872051Purushotham 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.
- Background: PubMed 10070303Bonnema 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.
- Background: PubMed 17006061Exadaktylos 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.
- Background: PubMed 10825330Sacerdote 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.
- Background: PubMed 7661350Yeager 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.
- Background: PubMed 14649342Naja 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.
- Background: PubMed 10456819Pusch 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.
- Background: PubMed 24617619Byager 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.
- Background: PubMed 24754798Campbell 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.
- Background: PubMed 7487214Lynch 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiva K Arava, MD,FRCA,EDRA principal investigator
Craigavon Area Hospital, SHSCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USG PECS2 with Drug A (active) and Wound infiltration with Drug A (active) in people with Breast Cancer Female, run by National Health Service, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption in Recovery (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555227, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.