Mastectomy; LymphedemaNCT07561411
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
A study testing Paravertebral block and Erector Spinae block in people with Mastectomy; Lymphedema and Chronic Pain, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastectomy; Lymphedema, Chronic Pain, Regional Anesthesia Morbidity
- What is being tested?
- Paravertebral block and Erector Spinae block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteLebanon
- Study dates
- 19 May 2026to 1 May 2028
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients between 18 and 80 years old.
- Scheduled to total mastectomy with or without axillary dissection
- Willing to receive regional anesthesia in addition to GA
- ASA classification 1-3
Who cannot join
- Previous thoracic surgery with an incision of >2 cm
- Patient's refusal
- Allergy to local anesthetics
- Pregnant women
- Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake.
- American Society of Anesthesiologists (ASA) classification of 4 or higher,
- History of chronic pain or untreated clinical severe depression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thouraya HajAli contact
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Nancy Abou Nafeh
About this study
Official title: The Effect of Erector Spinae Block Versus Paravertebral Block on the Incidence of Chronic Pain After Mastectomy: A Randomized Controlled Trial
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are:
- Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block?
- Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months?
Read more
Researchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures.
Participants will:
- Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery
- Undergo total mastectomy (with or without axillary dissection)
- Have their pain assessed in the PACU and at 24 and 48 hours postoperatively
- Have opioid consumption measured during the first 48 hours after surgery
- Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)
Read the detailed description
Background: Acute post mastectomy pain is a strong predictor of the development of chronic pain. Paravertebral block (PVB) has been shown to reduce the incidence and severity of acute and chronic pain post mastectomy. Despite the use of ultrasound, the performance of this advanced block requires special skills and training due to the proximity of the injection site to the pleura and the spinal cord. Erector spinae block (ESB), a novel regional anesthesia technique, has been shown to be equivalent to PVB in reducing the incidence and severity of acute post-surgical pain.
Specific aims: The primary objective of this study is to compare the effect of ESB and PVB on the incidence of chronic pain measured 3 months after mastectomy. Secondary objectives include assessment of cumulative opioid consumption at 48 hours post operatively, pain scores in the PACU as well as at 24 and 48 hours, time needed for performing the block, as well as complications, anxiety or depression at 3 months, pain intensity at 3 months. Methods: This prospective randomized clinical trial will be conducted in the operating rooms at AUBMC. 132 (66 in each group) adult patients scheduled to total mastectomy, with or without axillary dissection, and aging between 18 and 80 will be randomly allocated to 2 groups: The erector spinae group or the paravertebral group. Significance: It has not been demonstrated yet that the ESB is equivalent to the more conventional PVB in reducing the incidence of chronic post mastectomy pain. This study will compare the effect of ESB to PVB in reducing the incidence of chronic pain, which will improve the quality of life of patients undergoing modified radical mastectomy
- Being tested
- Paravertebral block, Erector Spinae block
- Medical subject headings
- Lymphedema, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockDrug
Also called TPVB
Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space.
Erector Spinae blockDrug
Also called ESPB
The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Active comparator | Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space. Receives: Drug: Paravertebral block |
| Erector Spinae block | Experimental | The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process Receives: Drug: Erector Spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Chronic pain measured using NRS scale (0-10) 3 months after mastectomy
Measured: 3 months after mastectomy
Secondary outcomes (5)
Cumulative opioid consumption
Cumulative opioid consumption
Measured: Amount of opioids used by the patient 48 hours after the procedure
Pain score
Pain score measured using NRS scale (0-10)
Measured: Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
Time needed for performing the block
Time needed for performing the block in minutes
Measured: Time needed for performing the block (Perioperative)
Complications
Incidence of complications (Yes/No)
Measured: Incidence of complications (Yes/No) (Perioperative)
Anxiety or depression
Anxiety or depression measured using HADS
Measured: Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start19 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Abou Nafeh, American University of Beirut Medical Center
- Investigators
- Nancy Abou Nafeh, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561411
- Sponsor's protocol ID
- BIO-2025-0326
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 2 Jun 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Block Versus Paravertebral Block on the Incidence of Chronic Pain After Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07561411
- Acronym / sponsor ID
- BIO-2025-0326
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 1 May 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.
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are:
- Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block?
- Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months?
Researchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures.
Participants will:
- Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery
- Undergo total mastectomy (with or without axillary dissection)
- Have their pain assessed in the PACU and at 24 and 48 hours postoperatively
- Have opioid consumption measured during the first 48 hours after surgery
- Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)
Detailed description
Background: Acute post mastectomy pain is a strong predictor of the development of chronic pain. Paravertebral block (PVB) has been shown to reduce the incidence and severity of acute and chronic pain post mastectomy. Despite the use of ultrasound, the performance of this advanced block requires special skills and training due to the proximity of the injection site to the pleura and the spinal cord. Erector spinae block (ESB), a novel regional anesthesia technique, has been shown to be equivalent to PVB in reducing the incidence and severity of acute post-surgical pain.
Specific aims: The primary objective of this study is to compare the effect of ESB and PVB on the incidence of chronic pain measured 3 months after mastectomy. Secondary objectives include assessment of cumulative opioid consumption at 48 hours post operatively, pain scores in the PACU as well as at 24 and 48 hours, time needed for performing the block, as well as complications, anxiety or depression at 3 months, pain intensity at 3 months. Methods: This prospective randomized clinical trial will be conducted in the operating rooms at AUBMC. 132 (66 in each group) adult patients scheduled to total mastectomy, with or without axillary dissection, and aging between 18 and 80 will be randomly allocated to 2 groups: The erector spinae group or the paravertebral group. Significance: It has not been demonstrated yet that the ESB is equivalent to the more conventional PVB in reducing the incidence of chronic post mastectomy pain. This study will compare the effect of ESB to PVB in reducing the incidence of chronic pain, which will improve the quality of life of patients undergoing modified radical mastectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Active comparator | Drug: Paravertebral blockThoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space. |
| Erector Spinae block | Experimental | Drug: Erector Spinae blockThe ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients between 18 and 80 years old.
- Scheduled to total mastectomy with or without axillary dissection
- Willing to receive regional anesthesia in addition to GA
- ASA classification 1-3
Key exclusion criteria (7 listed)
- Previous thoracic surgery with an incision of >2 cm
- Patient's refusal
- Allergy to local anesthetics
- Pregnant women
- Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake.
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 blockAlso: TPVBThoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space. | Drug | Paravertebral block |
| Erector Spinae blockAlso: ESPBThe ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process. | Drug | Erector Spinae block |
Primary outcome
Chronic pain
Time frame: 3 months after mastectomy
Chronic pain measured using NRS scale (0-10) 3 months after mastectomy
5 secondary outcomes
Cumulative opioid consumption
Time frame: Amount of opioids used by the patient 48 hours after the procedure
Pain score
Time frame: Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
Time needed for performing the block
Time frame: Time needed for performing the block (Perioperative)
Complications
Time frame: Incidence of complications (Yes/No) (Perioperative)
Anxiety or depression
Time frame: Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure.
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 2 Jun 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.
Thouraya HajAli contact
Nancy Abou Nafeh, MD principal investigator
American University of Beirut Medical Center
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 Erector Spinae block in people with Mastectomy; Lymphedema and Chronic Pain, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 4 inclusion and 7 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 2 Jun 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 Lebanon. 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 Nancy Abou Nafeh, MD (01350000 ext. 6820, na181@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain (time frame: 3 months after mastectomy). 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 2 Jun 2026.