Breast CancerPhase 4PECSNCT04116021
The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy
A Phase 4 study testing PECS block and Local infiltration in people with Breast Cancer, run by Hôpital du Valais.
Trial summary
This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PECS block and Local infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 Jun 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral mastectomy
- American Society of Anesthesiology Physical Status I-III
- Age ≥ 18
Who cannot join
- Contraindications to regional anesthesia, such as infection at the surgical site
- Pregnancy
- History of alcohol or drug dependence/abuse
- History of long term opioid intake
- Chronic pain disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy: a Randomized, Controlled, Double Blinded Trial
This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.
Read the detailed description
Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia.
Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed.
In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration).
Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed.
Both patients and outcome assessors will be blinded to group allocation.
- Conditions
- Breast Cancer
- Being tested
- PECS block, Local infiltration
- Keywords
- mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS blockOther
Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %
Local infiltrationOther
Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %
| Study group | Role | What they receive |
|---|---|---|
| PECS block | Active comparator | Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision Receives: Other: PECS block |
| Wound infiltration | Active comparator | Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery Receives: Other: Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Cumulative intravenous morphine consumption (mg)
Measured: first 24 postoperative hours
Secondary outcomes (7)
Pain score at rest at 2 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 2 hours postoperatively
Pain score at rest at 12 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 12 hours postoperatively
Pain score at rest at 24 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 24 hours postoperatively
Pain score on movement at 2 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 2 hours postoperatively
Pain score on movement at 12 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 12 hours postoperatively
Pain score on movement at 24 hours postoperatively
Numeric rating scale from 0 = no pain to 10 = worst imaginable pain
Measured: 24 hours postoperatively
Time to first analgesic request
Time between end of surgery and first analgesic request by patient, in minutes
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Sina Grape, Principal investigator, Hopital du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116021
- Sponsor's protocol ID
- PECS 2019
- Acronym
- PECS
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy: a Randomized, Controlled, Double Blinded Trial
- ClinicalTrials.gov ID
- NCT04116021
- Acronym / sponsor ID
- PECS / PECS 2019
- Conditions
- Breast Cancer
- Keywords
- mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 4 Oct 2019 (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.
This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.
Detailed description
Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia.
Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed.
In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration).
Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed.
Both patients and outcome assessors will be blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| PECS block | Active comparator | Other: PECS blockUltrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision |
| Wound infiltration | Active comparator | Other: Local infiltrationWound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral mastectomy
- American Society of Anesthesiology Physical Status I-III
- Age ≥ 18
Key exclusion criteria (5 listed)
- Contraindications to regional anesthesia, such as infection at the surgical site
- Pregnancy
- History of alcohol or drug dependence/abuse
- History of long term opioid intake
- Chronic pain disorder
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 blockUltrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 % | Other | PECS block |
| Local infiltrationWound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 % | Other | Wound infiltration |
Primary outcome
Morphine consumption
Time frame: first 24 postoperative hours
Cumulative intravenous morphine consumption (mg)
7 secondary outcomes
Pain score at rest at 2 hours postoperatively
Time frame: 2 hours postoperatively
Pain score at rest at 12 hours postoperatively
Time frame: 12 hours postoperatively
Pain score at rest at 24 hours postoperatively
Time frame: 24 hours postoperatively
Pain score on movement at 2 hours postoperatively
Time frame: 2 hours postoperatively
Pain score on movement at 12 hours postoperatively
Time frame: 12 hours postoperatively
Pain score on movement at 24 hours postoperatively
Time frame: 24 hours postoperatively
Time to first analgesic request
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- 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.
Sina Grape principal investigator
Hopital du Valais
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PECS block and Local infiltration in people with Breast Cancer, run by Hôpital du Valais.
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: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sina Grape, MD (0041276038759, sina.grape@hopitalvs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: first 24 postoperative hours). 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 4 Oct 2019.