Breast SurgeryNCT06383845
Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.
A study testing Lido-IV and ESP Block in people with Breast Surgery, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP). For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Lido-IV and ESP Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2023to 30 Sep 2025
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- patients aged 18 and older
- American Society of anesthesiologists classification I or II
- patients proposed for planned mastectomy with axillary lymph node dissection.
- hemodynamic stability.
Who cannot join
- patient refusal
- male gender
- history of major surgery within the year.
- allergy to local anesthetics
- BMI>40
- hemodynamic instability
Show all 9Show fewer
- Patients on long-term analgesics
- Severe heart and/or kidney damage
- neurological/psychiatric impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial
Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.
Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.
Read the detailed description
Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%.
For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.
- Conditions
- Breast Surgery
- Being tested
- Lido-IV, ESP Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lido-IVDrug
Also called Lidocaine-IV
Intravenous Lidocaine dose loading than a continuous infusion
ESP BlockDrug
Also called Erector Spinae Block
ultrasound guided block with injection of Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-IV | Experimental | Intravenous Lidocaine dose loading than continuous infusion Receives: Drug: Lido-IV |
| Erector spinae Block | Active comparator | An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75% Receives: Drug: ESP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Item 5 of Brief Pain inventory score (BPI Score)
Note of Brief Pain inventory Scale (BPI Score)
Measured: item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post surgery
Secondary outcomes (5)
Acute pain assessed by Simple Verbal Scale (SVS)
Acute Postoperative pain was assessed by the Simple Verbal Scale (SVS)
Measured: Postoperatively, at Hour 2, Hour 12 and Hour 24
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting during the first 24 hours
Measured: During the first 24hours postoperatively
Hospital length of stay
hospital length of stay (in days)
Measured: From the end of the surgery to discharge from the hospital
DN4 questionnaire (DN4)
DN4 questionnaire scale
Measured: DN4 represented by 10 items with a score from a minimum of 0 to a maximum of 10, at 03 and 06 months post surgery
The short-form McGill Pain Questionnaire (SFM-PQ)
The short-form McGill Pain Questionnaire Scale: Sensory and affective components of pain (11 sensory items and 4 affective items)
Measured: the 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 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 posted25 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Jan 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies 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
- Model description
- Erector spinae plane block VS intravenous lidocaine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HibetAllah Ktata, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383845
- Sponsor's protocol ID
- MAS ESLI
- Status last verified
- Nov 2025
- First submitted
- 14 Apr 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06383845
- Acronym / sponsor ID
- MAS ESLI
- Conditions
- Breast Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Apr 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.
Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.
Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.
Detailed description
Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%.
For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Erector spinae plane block VS intravenous lidocaine.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-IV | Experimental | Drug: Lido-IVIntravenous Lidocaine dose loading than continuous infusion |
| Erector spinae Block | Active comparator | Drug: ESP BlockAn ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients
- patients aged 18 and older
- American Society of anesthesiologists classification I or II
- patients proposed for planned mastectomy with axillary lymph node dissection.
- hemodynamic stability.
Key exclusion criteria (9 listed)
- patient refusal
- male gender
- history of major surgery within the year.
- allergy to local anesthetics
- BMI>40
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 |
|---|---|---|
| Lido-IVAlso: Lidocaine-IVIntravenous Lidocaine dose loading than a continuous infusion | Drug | Lidocaine-IV |
| ESP BlockAlso: Erector Spinae Blockultrasound guided block with injection of Ropivacaine | Drug | Erector spinae Block |
Primary outcome
Item 5 of Brief Pain inventory score (BPI Score)
Time frame: item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post surgery
Note of Brief Pain inventory Scale (BPI Score)
5 secondary outcomes
Acute pain assessed by Simple Verbal Scale (SVS)
Time frame: Postoperatively, at Hour 2, Hour 12 and Hour 24
Postoperative nausea and vomiting
Time frame: During the first 24hours postoperatively
Hospital length of stay
Time frame: From the end of the surgery to discharge from the hospital
DN4 questionnaire (DN4)
Time frame: DN4 represented by 10 items with a score from a minimum of 0 to a maximum of 10, at 03 and 06 months post surgery
The short-form McGill Pain Questionnaire (SFM-PQ)
Time frame: the 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 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 18 Nov 2025.
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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 Lido-IV and ESP Block in people with Breast Surgery, 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 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: finished, as of the sponsor's last update on 18 Nov 2025. 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?
Item 5 of Brief Pain inventory score (BPI Score) (time frame: item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post 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 18 Nov 2025.