Breast CancerBPV-MASTNCT07817797
Paravertebral Block and Reduction in Opioid Consumption After Mastectomy
A study testing Paravertebral Block and Multimodal Analgesia in people with Breast Cancer, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
This prospective randomized study evaluates the efficacy of paravertebral block in reducing opioid consumption during mastectomy and its impact on acute and chronic postoperative pain. 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?
- Paravertebral Block and Multimodal Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2018to 20 Dec 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
- Female participants aged more than 18 years.
- ASA physical status I or II.
- Breast cancer.
- Scheduled for unilateral mastectomy with or without axillary lymph node --dissection.
- Written informed consent.
Who cannot join
- Allergy to local anesthetics and/or level 1 or 2 analgesics.
- Contraindication to paravertebral block, including sepsis or coagulation -disorders.
- Use of antiarrhythmic drugs.
- Long-term analgesic treatment.
- Preoperative chemotherapy and/or radiotherapy.
- Metastatic or complicated breast cancer.
- Thoracic spinal malformations or neuropathy.
- History of peptic ulcer disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Block: Perioperative Opioid-sparing Effect - Acute and Chronic Post-mastectomy Pain.
This prospective randomized study evaluates the efficacy of paravertebral block in reducing opioid consumption during mastectomy and its impact on acute and chronic postoperative pain.
Participants are women over 18 years of age, classified as ASA physical status I or II, with breast cancer and scheduled to undergo unilateral mastectomy with or without axillary lymph node dissection. Participants are randomly assigned to two groups: one receiving a paravertebral block and the other receiving multimodal analgesia.
Read more
The primary outcome is intraoperative fentanyl consumption. Secondary outcomes include hypnotic and neuromuscular blocking agent consumption, the quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, as well as acute postoperative pain and chronic pain assessed three months after surgery.
The study aims to determine whether paravertebral block provides intraoperative opioid-sparing effects and contributes to improved postoperative pain management following mastectomy.
Read the detailed description
This was a prospective, randomized, blinded-assessor study conducted in the Department of Anesthesiology and Intensive Care at the Tunis Maternity and Neonatology Center.
The study included women over 18 years of age, classified as ASA physical status I or II, with breast cancer and scheduled to undergo unilateral mastectomy with or without axillary lymph node dissection. Patients were randomly allocated immediately before entering the operating room into two groups according to a randomization table: Group A received a paravertebral block, while Group B received multimodal analgesia.
In the paravertebral block group, the block was performed under ultrasound guidance on the side of the planned surgery. General anesthesia was then administered according to the study anesthesia protocol.
Postoperative monitoring included close monitoring of vital signs and pain assessment at H0, H6, H12, and H24. Patients were subsequently assessed at three months to identify the presence of chronic postoperative pain and evaluate its severity using the Verbal Rating Scale and the Saint-Antoine Pain Questionnaire.
The primary outcome was intraoperative fentanyl consumption. Secondary outcomes included hypnotic and neuromuscular blocking agent consumption, quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, acute postoperative pain, analgesic consumption, time to ambulation, and chronic pain at three months.
The study protocol included a sample size calculation based on an alpha risk of 5% and a statistical power of 90%. Statistical analysis was performed using SPSS version 20.0. The Chi-square or Fisher's exact test, Student's t-test, and Mann-Whitney U test were used according to the nature of the variables, with the significance threshold set at p < 0.05.
The study was conducted after obtaining approval from the local ethics committee and written informed consent from all participants.
- Conditions
- Breast Cancer
- Being tested
- Paravertebral Block, Multimodal Analgesia
- Keywords
- Paravertebral Block, Mastectomy, Perioperative Analgesia, Fentanyl Consumption, Acute Postoperative Pain, Chronic Postoperative Pain, Opioid-Sparing Analgesia
- Medical subject headings
- Breast Neoplasms, 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
Ultrasound-guided paravertebral block performed on the operative side before general anesthesia for mastectomy.
Multimodal AnalgesiaOther
Multimodal analgesia consisting of paracetamol and nefopam administered according to the study protocol, with additional postoperative analgesics according to pain intensity.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Experimental | Participants receive an ultrasound-guided paravertebral block on the operative side before general anesthesia for unilateral mastectomy. Receives: Procedure: Paravertebral Block |
| Multimodal Analgesia | Experimental | Participants receive multimodal analgesia without paravertebral block according to the study protocol. Receives: Other: Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative fentanyl consumption
Total perioperative fentanyl consumption during surgery.
Measured: During surgery / perioperative period
Secondary outcomes (8)
Perioperative hypnotic consumption
Amount of hypnotic drugs administered during surgery.
Measured: During surgery
Perioperative neuromuscular blocker consumption
Amount of neuromuscular blocking agents administered during surgery.
Measured: During surgery
Quality of Emergence From General Anesthesia
Quality of emergence from general anesthesia assessed clinically as calm, agitated, or in pain.
Measured: Perioperative
Time to Emergence From General Anesthesia
Time from completion of the surgical dressing to extubation, measured in minutes.
Measured: Perioperative
Adverse Events Related to Paravertebral Block
Incidence of adverse events related to paravertebral block, including systemic local anesthetic toxicity, hematoma, and pneumothorax.
Measured: Perioperative/Periprocedural
Acute Postoperative Pain Assessed Using the Visual Analog Scale
Acute postoperative pain assessed using the Visual Analog Scale (VAS). The VAS is a 100-mm horizontal scale ranging from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain intensity. Pain intensity was measured at 0, 6, 12, and 24 hours after surgery.
Measured: 0, 6, 12, and 24 hours after surgery
Chronic postoperative pain severity assessed three months after surgery using the Simple Verbal Scale (SVS)
Chronic postoperative pain severity assessed three months after surgery using the Simple Verbal Scale (SVS). The SVS is a 5-point categorical pain scale ranging from 0 (no pain) to 4 (extremely severe pain), with intermediate categories of 1 (mild pain), 2 (moderate pain), and 3 (severe pain). Higher scores indicate greater pain severity.
Measured: 3 months after surgery
Chronic Postoperative Pain Characteristics Assessed Using the Saint Antoine Pain Questionnaire
Chronic postoperative pain characteristics assessed three months after surgery using the Saint Antoine Pain Questionnaire (QDSA - Questionnaire Douleur Saint Antoine). The QDSA is a validated multidimensional French-language pain questionnaire assessing both sensory and affective dimensions of pain. Each descriptor is rated on a 5-point scale from 0 (absent) to 4 (extremely intense), with higher scores indicating greater pain intensity or unpleasantness. The total score ranges from 0 to 96, with higher scores indicating more severe pain characteristics.
Measured: 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 posted14 Sep 2026
- Study start1 Jan 2018
- Primary completion2 Nov 2020
- Study completion20 Dec 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, two-parallel-group study comparing a group receiving a paravertebral block with a group receiving multimodal analgesia in patients undergoing unilateral mastectomy with or without axillary lymph node dissection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817797
- Sponsor's protocol ID
- BPV-MAST-001
- Acronym
- BPV-MAST
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 14 Sep 2026
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block: Perioperative Opioid-sparing Effect - Acute and Chronic Post-mastectomy Pain.
- ClinicalTrials.gov ID
- NCT07817797
- Acronym / sponsor ID
- BPV-MAST / BPV-MAST-001
- Conditions
- Breast Cancer
- Keywords
- Paravertebral Block, Mastectomy, Perioperative Analgesia, Fentanyl Consumption, Acute Postoperative Pain, Chronic Postoperative Pain, Opioid-Sparing Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 14 Sep 2026 (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 prospective randomized study evaluates the efficacy of paravertebral block in reducing opioid consumption during mastectomy and its impact on acute and chronic postoperative pain.
Participants are women over 18 years of age, classified as ASA physical status I or II, with breast cancer and scheduled to undergo unilateral mastectomy with or without axillary lymph node dissection. Participants are randomly assigned to two groups: one receiving a paravertebral block and the other receiving multimodal analgesia.
The primary outcome is intraoperative fentanyl consumption. Secondary outcomes include hypnotic and neuromuscular blocking agent consumption, the quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, as well as acute postoperative pain and chronic pain assessed three months after surgery.
The study aims to determine whether paravertebral block provides intraoperative opioid-sparing effects and contributes to improved postoperative pain management following mastectomy.
Detailed description
This was a prospective, randomized, blinded-assessor study conducted in the Department of Anesthesiology and Intensive Care at the Tunis Maternity and Neonatology Center.
The study included women over 18 years of age, classified as ASA physical status I or II, with breast cancer and scheduled to undergo unilateral mastectomy with or without axillary lymph node dissection. Patients were randomly allocated immediately before entering the operating room into two groups according to a randomization table: Group A received a paravertebral block, while Group B received multimodal analgesia.
In the paravertebral block group, the block was performed under ultrasound guidance on the side of the planned surgery. General anesthesia was then administered according to the study anesthesia protocol.
Postoperative monitoring included close monitoring of vital signs and pain assessment at H0, H6, H12, and H24. Patients were subsequently assessed at three months to identify the presence of chronic postoperative pain and evaluate its severity using the Verbal Rating Scale and the Saint-Antoine Pain Questionnaire.
The primary outcome was intraoperative fentanyl consumption. Secondary outcomes included hypnotic and neuromuscular blocking agent consumption, quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, acute postoperative pain, analgesic consumption, time to ambulation, and chronic pain at three months.
The study protocol included a sample size calculation based on an alpha risk of 5% and a statistical power of 90%. Statistical analysis was performed using SPSS version 20.0. The Chi-square or Fisher's exact test, Student's t-test, and Mann-Whitney U test were used according to the nature of the variables, with the significance threshold set at p < 0.05.
The study was conducted after obtaining approval from the local ethics committee and written informed consent from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, two-parallel-group study comparing a group receiving a paravertebral block with a group receiving multimodal analgesia in patients undergoing unilateral mastectomy with or without axillary lymph node dissection.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Experimental | Procedure: Paravertebral BlockParticipants receive an ultrasound-guided paravertebral block on the operative side before general anesthesia for unilateral mastectomy. |
| Multimodal Analgesia | Experimental | Other: Multimodal AnalgesiaParticipants receive multimodal analgesia without paravertebral block according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged more than 18 years.
- ASA physical status I or II.
- Breast cancer.
- Scheduled for unilateral mastectomy with or without axillary lymph node --dissection.
- Written informed consent.
Key exclusion criteria (8 listed)
- Allergy to local anesthetics and/or level 1 or 2 analgesics.
- Contraindication to paravertebral block, including sepsis or coagulation -disorders.
- Use of antiarrhythmic drugs.
- Long-term analgesic treatment.
- Preoperative chemotherapy and/or radiotherapy.
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 BlockUltrasound-guided paravertebral block performed on the operative side before general anesthesia for mastectomy. | Procedure or surgery | Paravertebral Block |
| Multimodal AnalgesiaMultimodal analgesia consisting of paracetamol and nefopam administered according to the study protocol, with additional postoperative analgesics according to pain intensity. | Other | Multimodal Analgesia |
Primary outcome
Perioperative fentanyl consumption
Time frame: During surgery / perioperative period
Total perioperative fentanyl consumption during surgery.
8 secondary outcomes
Perioperative hypnotic consumption
Time frame: During surgery
Perioperative neuromuscular blocker consumption
Time frame: During surgery
Quality of Emergence From General Anesthesia
Time frame: Perioperative
Time to Emergence From General Anesthesia
Time frame: Perioperative
Adverse Events Related to Paravertebral Block
Time frame: Perioperative/Periprocedural
Acute Postoperative Pain Assessed Using the Visual Analog Scale
Time frame: 0, 6, 12, and 24 hours after surgery
Chronic postoperative pain severity assessed three months after surgery using the Simple Verbal Scale (SVS)
Time frame: 3 months after surgery
Chronic Postoperative Pain Characteristics Assessed Using the Saint Antoine Pain Questionnaire
Time frame: 3 months after surgery
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 14 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multimodal Analgesia in people with Breast Cancer, run by University Tunis El Manar at 1 site in Tunisia.
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 5 inclusion and 8 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 14 Sep 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 Tunisia. 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?
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?
Perioperative fentanyl consumption (time frame: During surgery / perioperative period). 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 14 Sep 2026.