Postoperative PainNCT06276257
Paravertebral Block for Mastectomy With Immediate Reconstruction
A study testing Paravertebral block and Usual analgesia in people with Postoperative Pain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paravertebral block and Usual analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- woman scheduled for unilateral mastectomy with immediate reconstruction
Who cannot join
- Patients who will have an axillary dissection during surgery.
- Woman with severe hepatic insufficiency (Child Pugh Classification B and above24).
- Woman with kidney failure stage 4 and above25.
- Body mass index (BMI) > 40 kg/m2.
- Woman with an allergy to local anesthetics.
- Woman with a bleeding disorder in whom BPV is contraindicated.
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- Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia.
- Woman with a single lung.
- Pregnant woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU de Quebec - Universite Laval
Québec, Quebec, G1H5B8
Martin Beaumont, 418-525-4444, Martin.Beaumont@chudequebec.ca
About this study
Official title: Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction
Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.
The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.
- Conditions
- Postoperative Pain
- Being tested
- Paravertebral block, Usual analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockProcedure or surgery
An ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.
Usual analgesiaProcedure or surgery
The patient will receive analgesia as per the anesthesiologist's preferences.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Experimental | Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia. Receives: Procedure: Paravertebral block |
| Usual analgesia | Active comparator | Usual analgesia, as per anesthesiologist's preferences. Receives: Procedure: Usual analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative pain using the BPI
Postoperative pain will be measured using the Brief Pain Inventory (BPI)
Measured: 24 hours, 28 hours, 72 hours after surgery
Secondary outcomes (6)
Total use of opioids received intraoperatively.
Total dose of narcotics received intraoperatively (in mg morphine equivalent)
Measured: within 3 months after surgery
Use of non-opioid analgesia intraoperatively
Analgesics other than opioids used intraoperatively
Measured: During surgery
Total dose of opioids received in the PACU
Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)
Measured: During PACU stay
Time before first opioid
Time to first opioid dose after surgery
Measured: Within 3 months after surgery
Total opioids consumed in the 48 hours following surgery
Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)
Measured: Within 48 hours after surgery
Chronic pain
Presence of chronic pain at the surgical site at 3 months
Measured: At 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start5 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276257
- Sponsor's protocol ID
- 2024-7301
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction
- ClinicalTrials.gov ID
- NCT06276257
- Acronym / sponsor ID
- 2024-7301
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 2024 (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.
Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.
The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Experimental | Procedure: Paravertebral blockPreoperative paravertebral block on the side of mastectomy in addition to usual analgesia. |
| Usual analgesia | Active comparator | Procedure: Usual analgesiaUsual analgesia, as per anesthesiologist's preferences. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 years of age
- woman scheduled for unilateral mastectomy with immediate reconstruction
Key exclusion criteria (9 listed)
- Patients who will have an axillary dissection during surgery.
- Woman with severe hepatic insufficiency (Child Pugh Classification B and above24).
- Woman with kidney failure stage 4 and above25.
- Body mass index (BMI) > 40 kg/m2.
- Woman with an allergy to local anesthetics.
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 |
|---|---|---|
| Paravertebral blockAn ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae. | Procedure or surgery | Paravertebral block |
| Usual analgesiaThe patient will receive analgesia as per the anesthesiologist's preferences. | Procedure or surgery | Usual analgesia |
Primary outcome
Evaluation of postoperative pain using the BPI
Time frame: 24 hours, 28 hours, 72 hours after surgery
Postoperative pain will be measured using the Brief Pain Inventory (BPI)
6 secondary outcomes
Total use of opioids received intraoperatively.
Time frame: within 3 months after surgery
Use of non-opioid analgesia intraoperatively
Time frame: During surgery
Total dose of opioids received in the PACU
Time frame: During PACU stay
Time before first opioid
Time frame: Within 3 months after surgery
Total opioids consumed in the 48 hours following surgery
Time frame: Within 48 hours after surgery
Chronic pain
Time frame: At 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block and Usual analgesia in people with Postoperative Pain, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 9 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Charles Hogue (418-525-4444, jean-charles.hogue@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of postoperative pain using the BPI (time frame: 24 hours, 28 hours, 72 hours after surgery). 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 19 Mar 2026.