Pain, PostoperativeNCT02849236
PECS I Block for Breast Subpectoral Implant Surgery
A study testing Ropivacaine (PECS bloc) in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
Trial summary
Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine (PECS bloc)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2016to Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Every female who will benefit of a bilateral subpectoral breast augmentation
- Age more than 18 years
- Social insured
Who cannot join
- refusal of the patient
- Age less than 18 years
- Inability to consent
- History of thoracic surgery or breast implants
- Pregnancy
- Inability to use a patient controlled analgesia
Show all 11Show fewer
- Contraindication of the use of opioids or local anesthetics
- Pathology of hemostasis, infection
- Can not use a PCA
- Patients under long-term opioids (WHO pain ladder 2 and 3)
- Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine (PECS bloc), Placebo
- Keywords
- PECS block,, pectoral block,, breast augmentation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine (PECS bloc)Drug
Also called ropivacaine
Ropivacaine 3.75mg/mL
Injection of a local anesthetic between pectoral major and pectoral minor muscles
PlaceboDrug
Also called saline
20 mL saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | PECS block performed with Saline solution instead of local anesthetic Receives: Drug: Placebo |
| PECS group | Experimental | PECS block performed with Ropivacaine 3.75mg/mL Receives: Drug: Ropivacaine (PECS bloc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.
Measured: During the first 24 postoperative hours
Secondary outcomes (8)
First administration of morphine
Time elapsed between tracheal extubation and first administration of morphine
Measured: During the first 24 postoperative hours
Post-operative nausea and/or vomiting
Number of nausea and/or vomiting episodes in the twenty-four hours after surgery
Measured: During the first 24 postoperative hours
Intra-operative opioids consumption
Sufentanil consumption during anesthesia
Measured: During procedure execution
Post-operative anti-emetic consumption
Consumption of anti-emetic drugs after surgery
Measured: During the first 24 postoperative hours
Post-operative pain
Evaluation of post-operative pain with a digital scale from 0 to 10 in the first twenty four hours after surgery
Measured: During the first 24 postoperative hours
4-point sedation scale
using WHO Sedation scale
- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
Measured: During the first two postoperative hours
Aldrete score
Aldrete Score is a medical scoring system for the measurement of recovery after anesthesia (post anesthesia) which includes activity, respiration, consciousness, blood circulation and color.
Measured: During the first two postoperative hours
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Measured: During the first six postoperative hours after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start16 Oct 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Tavernier, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849236
- Sponsor's protocol ID
- 2015_17
- Other IDs
- 2016-000157-12, 2016
- Status last verified
- Aug 2020
- First submitted
- 19 Jul 2016
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02849236
- Acronym / sponsor ID
- 2015_17
- Conditions
- Pain, Postoperative
- Keywords
- PECS block,, pectoral block,, breast augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 29 Jul 2016 (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.
Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboPECS block performed with Saline solution instead of local anesthetic |
| PECS group | Experimental | Drug: Ropivacaine (PECS bloc)PECS block performed with Ropivacaine 3.75mg/mL |
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)
- Every female who will benefit of a bilateral subpectoral breast augmentation
- Age more than 18 years
- Social insured
Key exclusion criteria (11 listed)
- refusal of the patient
- Age less than 18 years
- Inability to consent
- History of thoracic surgery or breast implants
- Pregnancy
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 |
|---|---|---|
| Ropivacaine (PECS bloc)Also: ropivacaineRopivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles | Drug | PECS group |
| PlaceboAlso: saline20 mL saline 0.9% | Drug | Control group |
Primary outcome
Morphine consumption
Time frame: During the first 24 postoperative hours
Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.
8 secondary outcomes
First administration of morphine
Time frame: During the first 24 postoperative hours
Post-operative nausea and/or vomiting
Time frame: During the first 24 postoperative hours
Intra-operative opioids consumption
Time frame: During procedure execution
Post-operative anti-emetic consumption
Time frame: During the first 24 postoperative hours
Post-operative pain
Time frame: During the first 24 postoperative hours
4-point sedation scale
Time frame: During the first two postoperative hours
Aldrete score
Time frame: During the first two postoperative hours
Time physiological function recovery
Time frame: During the first six postoperative hours after tracheal extubation
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 26 Aug 2020.
- 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.
Benoit Tavernier, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine (PECS bloc) in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
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 11 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 26 Aug 2020. 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 France. 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?
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 (time frame: During the 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 26 Aug 2020.