Mastectomy; LymphedemaNCT03602794
A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study
A study testing PECs Block and Local infiltration in people with Mastectomy; Lymphedema and Local Infiltration, run by Louis Ng Xiang Long at 1 site in Singapore.
Trial summary
The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Mastectomy; Lymphedema, Local Infiltration, Anesthesia, Local
- What is being tested?
- PECs Block and Local infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Aug 2018to 16 Jul 2019
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 21 years old
- Able to give consent
- Body weight > 50kg
Who cannot join
- Patient's refusal and inability to give consent
- Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids
- Background history of chronic pain
- Bilateral procedures
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Kwee Lian Woon, +65 81211037
About this study
The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection.
Read the detailed description
Total breast removal with armpit dissection may be a painful surgery. Pectoral nerve block (Pecs block) is common pain relief method used to reduce pain after breast surgery.
The Pecs block is a pain relief method technique at targeted body part. The Pecs block numbs nerves which supply sensation to the upper chest wall, armpit and upper arm. This procedure is only possible under ultrasound guidance and is carried out by the anaesthetist (medical specialist who administers anaesthetics) after patients are put under general anaesthesia.
Despite the advantages of Pecs block in pain management, this method is not always available to all patients due to various reasons. These reasons include the availability of ultrasound machine to facilitate the method, presence of anaesthetist to carry out the procedure and additional time required to perform this method in the operating theatre.
Another method has been modified by our surgeons (medical specialist who performs surgery, a different specialty from anaesthetist) to achieve pain relief among patients undergoing breast removal surgery. This method is called local infiltration analgesia (LIA). The pain control is achieved by having the surgeons to deliver a pain control drug surgically during the breast removal operation. LIA could be a good pain control alternative when a Pecs block could not be performed.
The investigators hope to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance. The investigators hope to show that LIA delivered by surgeon is as effective as Pecs block in patients undergoing mastectomy with axillary dissection.
- Conditions
- Mastectomy; Lymphedema, Local Infiltration, Anesthesia, Local, Block
- Being tested
- PECs Block, Local infiltration
- Medical subject headings
- Lymphedema, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECs BlockProcedure or surgery
Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance
Local infiltrationProcedure or surgery
LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.
| Study group | Role | What they receive |
|---|---|---|
| PECs Block | Active comparator | Total local anaesthetic dose: 30ml ropivacaine 0.5%
•Pecs block will be performed by anaesthetist using ultrasound guidance in plane approach: 10ml ropivacaine 0.5% will be delivered at the plane between pectoralis major and pectoralis minor, another 20ml ropivacaine 0.5% will be delivered in the plane between the pectoralis minor and serratus anterior muscles at the level of the third and fourth ribs Receives: Procedure: PECs Block |
| Local Infiltration | Placebo comparator | LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles. Receives: Procedure: Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in 24 hour after surgery
Total morphine consumption in 24 hour after surgery
Measured: 24 hour
Secondary outcomes (12)
Duration of analgesia
time to first rescue analgesia after administration of block
Measured: 24 hours
Postoperative pain score.
Post op pain score will be assessed using a visual analogue scale (VAS, 0-10; 0 = no pain and 10 = worst imaginable pain). The vital signs and pain score will be recorded at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24 h after surgery by the attending staff nurses blinded to the group allocation
Measured: 24 hours
Adverse Effects
Any adverse effects will be recorded (such as hypotension, respiratory depression, pruritus, shivering and urinary retention)
Measured: 24 hours
Postoperative nausea vomiting (PONV)
Postoperative nausea vomiting (PONV)
Measured: 24 hours
Intraoperative analgesia
total usage of IV Fentanyl intraoperatively
Measured: 24 hours
Operative time
duration of surgery
Measured: 24 hrs
Block performance time
time from needle insertion until needle exit from the skin
Measured: 24 hours
Block related complications
pneumothorax
Measured: 24 hours
Block related complications
vascular puncture
Measured: 24 hours
Block related complications
local anaesthetic toxicity
Measured: 24 hours
Post-operative complications
Bleeding
Measured: 24 hours
Post-operative complications
Wound infection
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completion16 Jul 2019 (estimated)
- Study completion16 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mastectomy; LymphedemaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Ng Xiang Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louis Ng Xiang Long, Changi General Hospital
- Investigators
- Kwee Lian Woon, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602794
- Sponsor's protocol ID
- 2017/2894
- Status last verified
- Sep 2018
- First submitted
- 18 Jul 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22939099
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study
- ClinicalTrials.gov ID
- NCT03602794
- Acronym / sponsor ID
- 2017/2894
- Conditions
- Mastectomy; Lymphedema, Local Infiltration, Anesthesia, Local, Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Louis Ng Xiang LongUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 16 Jul 2019 (estimated)
- Study completion
- 16 Jul 2019 (estimated)
- First posted
- 27 Jul 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.
The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection.
Detailed description
Total breast removal with armpit dissection may be a painful surgery. Pectoral nerve block (Pecs block) is common pain relief method used to reduce pain after breast surgery.
The Pecs block is a pain relief method technique at targeted body part. The Pecs block numbs nerves which supply sensation to the upper chest wall, armpit and upper arm. This procedure is only possible under ultrasound guidance and is carried out by the anaesthetist (medical specialist who administers anaesthetics) after patients are put under general anaesthesia.
Despite the advantages of Pecs block in pain management, this method is not always available to all patients due to various reasons. These reasons include the availability of ultrasound machine to facilitate the method, presence of anaesthetist to carry out the procedure and additional time required to perform this method in the operating theatre.
Another method has been modified by our surgeons (medical specialist who performs surgery, a different specialty from anaesthetist) to achieve pain relief among patients undergoing breast removal surgery. This method is called local infiltration analgesia (LIA). The pain control is achieved by having the surgeons to deliver a pain control drug surgically during the breast removal operation. LIA could be a good pain control alternative when a Pecs block could not be performed.
The investigators hope to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance. The investigators hope to show that LIA delivered by surgeon is as effective as Pecs block in patients undergoing mastectomy with axillary dissection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled
| Arm | Type | Receives |
|---|---|---|
| PECs Block | Active comparator | Procedure: PECs BlockTotal local anaesthetic dose: 30ml ropivacaine 0.5% •Pecs block will be performed by anaesthetist using ultrasound guidance in plane approach: 10ml ropivacaine 0.5% will be delivered at the plane between pectoralis major and pectoralis minor, another 20ml ropivacaine 0.5% will be delivered in the plane between the pectoralis minor and serratus anterior muscles at the level of the third and fourth ribs |
| Local Infiltration | Placebo comparator | Procedure: Local infiltrationLIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 21 years old
- Able to give consent
- Body weight > 50kg
Key exclusion criteria (4 listed)
- Patient's refusal and inability to give consent
- Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids
- Background history of chronic pain
- Bilateral procedures
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 |
|---|---|---|
| PECs BlockRegional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance | Procedure or surgery | PECs Block |
| Local infiltrationLIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles. | Procedure or surgery | Local Infiltration |
Primary outcome
Total morphine consumption in 24 hour after surgery
Time frame: 24 hour
Total morphine consumption in 24 hour after surgery
12 secondary outcomes
Duration of analgesia
Time frame: 24 hours
Postoperative pain score.
Time frame: 24 hours
Adverse Effects
Time frame: 24 hours
Postoperative nausea vomiting (PONV)
Time frame: 24 hours
Intraoperative analgesia
Time frame: 24 hours
Operative time
Time frame: 24 hrs
Block performance time
Time frame: 24 hours
Block related complications
Time frame: 24 hours
Block related complications
Time frame: 24 hours
Block related complications
Time frame: 24 hours
Post-operative complications
Time frame: 24 hours
Post-operative complications
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 22939099Blanco 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.
- Ultrasound description of Pecs II (modified Pecs I): A novel approacj to breast surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kwee Lian Woon principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECs Block and Local infiltration in people with Mastectomy; Lymphedema and Local Infiltration, run by Louis Ng Xiang Long at 1 site in Singapore.
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 4 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 5 Sep 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 Singapore. 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. Some participants in this study may receive a placebo. 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 Kwee Lian Woon (+6581211037, Kwee_Lian_Woon@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption in 24 hour after surgery (time frame: 24 hour). 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 NCT03602794, which also lists 1 linked publication.
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 5 Sep 2018.