Pain, Post OperativeNCT02410746
Nerve Block Versus Non-targeted Local Anaesthesia in Breast Surgery
A study testing targeted chirocaine pec block, standard chirocaine infiltration and standard post-operative analgesia in people with Pain, Post Operative, run by BMI Healthcare at 1 site in United Kingdom.
Trial summary
Effective postoperative pain control is an essential component of surgery. Adequate analgesia improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster recovery and less likelihood of complications.The majority of surgeons will place 10ml of local anaesthetic into the breast pocket or… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Post Operative
- What is being tested?
- targeted chirocaine pec block, standard chirocaine infiltration and standard post-operative analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Sep 2016
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient requesting a bilateral breast procedure (reduction, mastopexy or augmentation).
- Patient willing to sign the informed consent form agreeing to its items after explanation of the study by the operating surgeon.
Who cannot join
- Declining to give written consent.
- History of allergy to chirocaine local anaesthetic.
- Prior breast surgery.
- Chronic pain disorder.
- Significant medical co-morbidities.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Edgbaston BMI Hospital
Birmingham, West Midlands, B152QQ
Anne Dancey, FRCS(Plast), 07808078276, anne@annedancey.co.uk
Anne Dancey
About this study
Official title: A Prospective, Randomised Double Blinded Study Comparing a Pectoral Nerve Block With Non-targeted Local Anaesthetic in Bilateral Breast Surgery
Effective postoperative pain control is an essential component of surgery. Adequate analgesia improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster recovery and less likelihood of complications.The majority of surgeons will place 10ml of local anaesthetic into the breast pocket or inject it into the breast skin following breast surgery. A more specific technique is to identify the nerves supplying the breast and put the local anaesthetic directly around them (Pec block). This nerve block has recently been described and is increasingly being used by anaesthetists for surgery under local anaesthetic or for post-operative analgesia. It has been shown to provide better and more specific pain relief in several studies.
Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves and they inject into the vicinity. They do not have direct vision and there is a risk of causing morbidity or the block not being effective. It is much easier for a surgeon to apply the block, as they can see the anatomical landmarks. Despite this, very few surgeons are aware of the technique.
Read more
The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and Worcester. If a patient consents to being involved in the research, they will have one breast randomised to receiving a pec block and the contralateral (opposite) breast will receive the same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The patients and researcher will be blinded as to the allocation. Patients will complete a verbal numeric pain score for each breast at set intervals until they are discharged.In addition, the investigators will specifically ask which breast is the most painful at each time point.
The results of the study may improve patient care.
Read the detailed description
The investigators' intention is to randomise all patients undergoing bilateral breast surgery into receiving a specific pec block in one breast and a standard infiltration of non targeted anaesthesia into the other breast. 10ml 0.25% Chirocaine will be used for each breast.
All patients attending the plastic surgery clinic at BMI Edgbaston, BMI Priory, Spire Parkway and Spire Southbank and requesting bilateral breast surgery will be approached to take part in the study. They will be given information to take home and an opportunity to ask any questions about the study.
All consenting patients who meet the inclusion criteria will have one breast randomised into a study group (pec block) and the other into a control group (standard local anaesthetic infiltration). Patients will be randomised by a computer generated code. The patient and researcher will be blinded. By necessity, the surgeon will be aware of the randomisation but will have no involvement in data collection or analysis of results.
Both groups will receive standard post-operative care and follow up. A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen. The investigators will prospectively record post operative pain as rated by a verbal numerical rating scale at 0, 3, 6, 9 and 12 hours post-operatively and at 24 hours. In addition the investigators will record which breast the patient indicates is the most painful and any post-operative complications throughout the study period . The expected recruitment period is six months.
If patients consent to inclusion in the study they will sign a consent form at a second appointment or on the day of surgery. The ward and recovery nurses already have experience in administering a VNRS for pain control.
- Conditions
- Pain, Post Operative
- Being tested
- targeted chirocaine pec block, standard chirocaine infiltration, standard post-operative analgesia
- Keywords
- pain, surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted chirocaine pec blockOther
Also called Pectoral nerve block
10ml 0.25% chirocaine in a specifically targeted in a nerve block
standard chirocaine infiltrationOther
Also called intra-operative analgesia
10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion
standard post-operative analgesiaOther
Also called Morphine, Paracetamol, ibuprofen, analgesia
A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen.
| Study group | Role | What they receive |
|---|---|---|
| standard chirocaine infiltration | Active comparator | non-targeted infiltration of 10ml 0.25% Chirocaine into breast pocket Receives: Other: standard chirocaine infiltration; Other: standard post-operative analgesia |
| targeted chirocaine pec block | Experimental | pectoral muscle block with 10ml 0.25% chirocaine Receives: Other: targeted chirocaine pec block; Other: standard post-operative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
targeted question as to which breast is more painful
patient is asked which breast is more painful
Measured: 3 hours post-operatively
Secondary outcomes (1)
verbal numeric rating scale(VNRS)
standard validated pain score
Measured: 3 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BMI Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Dancey, BMI Healthcare
- Investigators
- anne dancey, MBChB(hons), Principal investigator, AAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410746
- Sponsor's protocol ID
- PECBLOCKV1
- Status last verified
- Jul 2016
- First submitted
- 31 Mar 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: yes on individual request of the patient when study is completed
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Double Blinded Study Comparing a Pectoral Nerve Block With Non-targeted Local Anaesthetic in Bilateral Breast Surgery
- ClinicalTrials.gov ID
- NCT02410746
- Acronym / sponsor ID
- PECBLOCKV1
- Conditions
- Pain, Post Operative
- Keywords
- pain, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BMI HealthcareUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- 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.
Effective postoperative pain control is an essential component of surgery. Adequate analgesia improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster recovery and less likelihood of complications.The majority of surgeons will place 10ml of local anaesthetic into the breast pocket or inject it into the breast skin following breast surgery. A more specific technique is to identify the nerves supplying the breast and put the local anaesthetic directly around them (Pec block). This nerve block has recently been described and is increasingly being used by anaesthetists for surgery under local anaesthetic or for post-operative analgesia. It has been shown to provide better and more specific pain relief in several studies.
Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves and they inject into the vicinity. They do not have direct vision and there is a risk of causing morbidity or the block not being effective. It is much easier for a surgeon to apply the block, as they can see the anatomical landmarks. Despite this, very few surgeons are aware of the technique.
The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and Worcester. If a patient consents to being involved in the research, they will have one breast randomised to receiving a pec block and the contralateral (opposite) breast will receive the same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The patients and researcher will be blinded as to the allocation. Patients will complete a verbal numeric pain score for each breast at set intervals until they are discharged.In addition, the investigators will specifically ask which breast is the most painful at each time point.
The results of the study may improve patient care.
Detailed description
The investigators' intention is to randomise all patients undergoing bilateral breast surgery into receiving a specific pec block in one breast and a standard infiltration of non targeted anaesthesia into the other breast. 10ml 0.25% Chirocaine will be used for each breast.
All patients attending the plastic surgery clinic at BMI Edgbaston, BMI Priory, Spire Parkway and Spire Southbank and requesting bilateral breast surgery will be approached to take part in the study. They will be given information to take home and an opportunity to ask any questions about the study.
All consenting patients who meet the inclusion criteria will have one breast randomised into a study group (pec block) and the other into a control group (standard local anaesthetic infiltration). Patients will be randomised by a computer generated code. The patient and researcher will be blinded. By necessity, the surgeon will be aware of the randomisation but will have no involvement in data collection or analysis of results.
Both groups will receive standard post-operative care and follow up. A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen. The investigators will prospectively record post operative pain as rated by a verbal numerical rating scale at 0, 3, 6, 9 and 12 hours post-operatively and at 24 hours. In addition the investigators will record which breast the patient indicates is the most painful and any post-operative complications throughout the study period . The expected recruitment period is six months.
If patients consent to inclusion in the study they will sign a consent form at a second appointment or on the day of surgery. The ward and recovery nurses already have experience in administering a VNRS for pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard chirocaine infiltration | Active comparator | Other: standard chirocaine infiltration, Other: standard post-operative analgesianon-targeted infiltration of 10ml 0.25% Chirocaine into breast pocket |
| targeted chirocaine pec block | Experimental | Other: targeted chirocaine pec block, Other: standard post-operative analgesiapectoral muscle block with 10ml 0.25% chirocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient requesting a bilateral breast procedure (reduction, mastopexy or augmentation).
- Patient willing to sign the informed consent form agreeing to its items after explanation of the study by the operating surgeon.
Key exclusion criteria (5 listed)
- Declining to give written consent.
- History of allergy to chirocaine local anaesthetic.
- Prior breast surgery.
- Chronic pain disorder.
- Significant medical co-morbidities.
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 |
|---|---|---|
| targeted chirocaine pec blockAlso: Pectoral nerve block10ml 0.25% chirocaine in a specifically targeted in a nerve block | Other | targeted chirocaine pec block |
| standard chirocaine infiltrationAlso: intra-operative analgesia10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion | Other | standard chirocaine infiltration |
| standard post-operative analgesiaAlso: Morphine, Paracetamol, ibuprofen, analgesiaA dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen. | Other | standard chirocaine infiltration, targeted chirocaine pec block |
Primary outcome
targeted question as to which breast is more painful
Time frame: 3 hours post-operatively
patient is asked which breast is more painful
1 secondary outcome
verbal numeric rating scale(VNRS)
Time frame: 3 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: Yes. yes on individual request of the patient when study is completed
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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.
anne dancey, MBChB(hons) principal investigator
AAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing targeted chirocaine pec block, standard chirocaine infiltration and standard post-operative analgesia in people with Pain, Post Operative, run by BMI Healthcare 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 2 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Dancey, MBChB(Hons) (07808078276, annedancey@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
targeted question as to which breast is more painful (time frame: 3 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.