Post-mastectomy Pain SyndromeNCT04317898
Ultrasound-Guided Serratus Plane Block Vs Paravertebral Block For Chronic Post-mastectomy Pain.
A study testing serratus plane block by ultra-sound and paravertebral block by ultra-sound in people with Post-mastectomy Pain Syndrome, run by Assiut University.
Trial summary
compare the analgesic efficacy between ultrasound paraverbral block and serratus block in post mastectomy pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- serratus plane block by ultra-sound and paravertebral block by ultra-sound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jun 2021
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have postmastectomy pain of neuropathic nature, DN4
- 4 for at least 3ms duration.
- The intensity of postmastectomy pain on VAS score ≥ 5.
- Unsatisfactory treatment with 1st line antineuropathic drugs, Pregabalin(150 mg daily) or Deloxetine(60mg daily).
Who cannot join
- Infection of the skin at or near site of needle puncture.
- Coagulopathy .
- Drug hypersensitivity or allergy to the studied drugs.
- Central or peripheral neuropthy .
- Significant organ dysfunction .
- Morbid obesity (BMI>35kg/m2) .
- Vertebral anomalies.
Trial locations and contacts
No sites are listed yet.
About this study
compare the analgesic efficacy between ultrasound paraverbral block and serratus block in post mastectomy pain.
Read the detailed description
It is reported that postmastectomy pain syndrome (PMPS) is a common problem, ranging from 25% to 60%.
The pain is localized in the axilla, medial upper arm, breast, and/or chest wall and lasting beyond three months after surgery when all other causes of pain such as infection have been eliminated.
The pain seriously affects the patient's mood, everyday activities, and social function and causes heavy economic burden for the healthcare system.
Postmastectomy pain syndrome (PMPS) itself is not a specific diagnosis but rather describes a cluster of symptoms frequently observed in breast cancer survivors following treatment.
Many patients will experience short-term nociceptive pain after breast cancer treatment. However, with PMPS, patients frequently experience persistent neuropathic-type pain: burning, tingling, aching, a subjective sense of "tightness" around the chest wall, or even phantom breast or nipple pain. Neuropathic pain results from dysfunction of the peripheral nerves caused by surgery, radiation, or neurotoxic chemotherapies.
Currently, there are a wide variety of approaches to treat this type of pain. physical therapy has been employed as a modality to improve physical function.
As far as interventional procedures, intercostal nerve blockade, stellate ganglion blockade, and paravertebral blockade have all been utilized with varying degrees of success.
Paraverberal blocks have superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to provide analgesia for breast surgery.
The injection of local anaesthetic solution in the paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic. The uptake of the local anaesthetic solution is enhanced due to the absence of fascial sheaths binding the spinal nerves.
Another potential target for an interventional procedure for chronic pain after treatment for breast cancer is the serratus plane. The serratus plane block is a novel ultrasound-guided nerve block, which is able to anesthetize the hemithorax.
The serratus plane block relies on the fact that there are branches of the intercostal nerves following within 2 potential spaces, one superficial and one deep, surrounding the serratus anterior muscle. The serratus anterior muscle arises as strips from the first 9 ribs and converges posteriorly on the scapula to form the medial wall of the axilla.
The innervation of the serratus anterior muscle is via the long thoracic nerve (Bell's nerve), and the nerve itself is covered by the fascia of the serratus anterior muscle and lies anterior to the muscle.
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- serratus plane block by ultra-sound, paravertebral block by ultra-sound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus plane block by ultra-soundProcedure or surgery
To perform Serratus block, patients will be placed in the lateral decubitus position with the affected side facing up, or in the prone position with the affected side facing the operator . After sterile preparation, a linear ultrasound probe will be utilized to identify the latissimusdorsi and serratus anterior muscles in a sagittal plane. The plane superficial to the serratus anterior muscle and below the latissimusdorsi muscle will be identified. The skin will be topicalized with 1 mL of 1% lidocaine using a 30-gauge needle. Using an in-plane approach, a 25-gauge 1.5-cm needle will be used to inject a total of 20-mL of 0.25% bupivacaine with 80 mg of triamcinlone under direct ultrasound visualization.
paravertebral block by ultra-soundProcedure or surgery
TPVB will be given using high frequency linear US transducer, place the probe parallel to the vertebral spine at T2 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of plura, transverse process and paravertebral space, the needle will be inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 10ml of 0.25% bubivacine and 80mg triamcinlone slowly; the pleura will be seen to be pushed downward.
| Study group | Role | What they receive |
|---|---|---|
| serratus plane block | Active comparator | 20 ml of Bupivacine 0.25% +80mg triamcinlone will be injected in serratus plane under ultrasound. Receives: Procedure: serratus plane block by ultra-sound |
| paravertebral block | Active comparator | 10 ml of bubivacine 0.25% +80 mg triamcinlone will be injected at T2 level (paravertebral) under ultrasound. Receives: Procedure: paravertebral block by ultra-sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.
Compare the analgesic efficacy between ultrasound paraverbral block and serratus block in chronic postmastectomy pain.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study startJul 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abo eldahab Ali elden, Assiut University
- Investigators
- Mohammed Mohammed Abd El-Latif, Prof of Anesthesia, Study director, Mohammed MohammedAbd El-LatifAshraf Amin Mohammed, Prof of Anesthesia, Study director, Ashraf Amin MohammedRania Mohammed Abd El-Emam, Lecturer of Anesthesia, Study director, Rania Mohammed Abd El-Emam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317898
- Sponsor's protocol ID
- analgesia in chronic PMPs
- Status last verified
- Jul 2020
- First submitted
- 20 Mar 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
PubMed 19903919Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.
PubMed 10506676Couceiro TC, Menezes TC, Valenca MM. Post-mastectomy pain syndrome: the magnitude of the problem. Rev Bras Anestesiol. 2009 May-Jun;59(3):358-65. doi: 10.1590/s0034-70942009000300012. English, Portuguese.
PubMed 19488550Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.
PubMed 18635381Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, del Moral-Avila R, Castro-Sanchez AM, Arroyo-Morales M. Effectiveness of a multidimensional physical therapy program on pain, pressure hypersensitivity, and trigger points in breast cancer survivors: a randomized controlled clinical trial. Clin J Pain. 2012 Feb;28(2):113-21. doi: 10.1097/AJP.0b013e318225dc02.
PubMed 21705873Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.
PubMed 24918332
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Serratus Plane Block Vs Paravertebral Block For Chronic Post-mastectomy Pain.
- ClinicalTrials.gov ID
- NCT04317898
- Acronym / sponsor ID
- analgesia in chronic PMPs
- Conditions
- Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 23 Mar 2020 (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.
compare the analgesic efficacy between ultrasound paraverbral block and serratus block in post mastectomy pain.
Detailed description
It is reported that postmastectomy pain syndrome (PMPS) is a common problem, ranging from 25% to 60%.
The pain is localized in the axilla, medial upper arm, breast, and/or chest wall and lasting beyond three months after surgery when all other causes of pain such as infection have been eliminated.
The pain seriously affects the patient's mood, everyday activities, and social function and causes heavy economic burden for the healthcare system.
Postmastectomy pain syndrome (PMPS) itself is not a specific diagnosis but rather describes a cluster of symptoms frequently observed in breast cancer survivors following treatment.
Many patients will experience short-term nociceptive pain after breast cancer treatment. However, with PMPS, patients frequently experience persistent neuropathic-type pain: burning, tingling, aching, a subjective sense of "tightness" around the chest wall, or even phantom breast or nipple pain. Neuropathic pain results from dysfunction of the peripheral nerves caused by surgery, radiation, or neurotoxic chemotherapies.
Currently, there are a wide variety of approaches to treat this type of pain. physical therapy has been employed as a modality to improve physical function.
As far as interventional procedures, intercostal nerve blockade, stellate ganglion blockade, and paravertebral blockade have all been utilized with varying degrees of success.
Paraverberal blocks have superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to provide analgesia for breast surgery.
The injection of local anaesthetic solution in the paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic. The uptake of the local anaesthetic solution is enhanced due to the absence of fascial sheaths binding the spinal nerves.
Another potential target for an interventional procedure for chronic pain after treatment for breast cancer is the serratus plane. The serratus plane block is a novel ultrasound-guided nerve block, which is able to anesthetize the hemithorax.
The serratus plane block relies on the fact that there are branches of the intercostal nerves following within 2 potential spaces, one superficial and one deep, surrounding the serratus anterior muscle. The serratus anterior muscle arises as strips from the first 9 ribs and converges posteriorly on the scapula to form the medial wall of the axilla.
The innervation of the serratus anterior muscle is via the long thoracic nerve (Bell's nerve), and the nerve itself is covered by the fascia of the serratus anterior muscle and lies anterior to the muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serratus plane block | Active comparator | Procedure: serratus plane block by ultra-sound20 ml of Bupivacine 0.25% +80mg triamcinlone will be injected in serratus plane under ultrasound. |
| paravertebral block | Active comparator | Procedure: paravertebral block by ultra-sound10 ml of bubivacine 0.25% +80 mg triamcinlone will be injected at T2 level (paravertebral) under ultrasound. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have postmastectomy pain of neuropathic nature, DN4
- The intensity of postmastectomy pain on VAS score ≥ 5.
- Unsatisfactory treatment with 1st line antineuropathic drugs, Pregabalin(150 mg daily) or Deloxetine(60mg daily).
Key exclusion criteria (7 listed)
- Infection of the skin at or near site of needle puncture.
- Coagulopathy .
- Drug hypersensitivity or allergy to the studied drugs.
- Central or peripheral neuropthy .
- Significant organ dysfunction .
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 |
|---|---|---|
| serratus plane block by ultra-soundTo perform Serratus block, patients will be placed in the lateral decubitus position with the affected side facing up, or in the prone position with the affected side facing the operator . After sterile preparation, a linear ultrasound probe will be utilized to identify the latissimusdorsi and serratus anterior muscles in a sagittal plane. The plane superficial to the serratus anterior muscle and below the latissimusdorsi muscle will be identified. The skin will be topicalized with 1 mL of 1% lidocaine using a 30-gauge needle. Using an in-plane approach, a 25-gauge 1.5-cm needle will be used to inject a total of 20-mL of 0.25% bupivacaine with 80 mg of triamcinlone under direct ultrasound visualization. | Procedure or surgery | serratus plane block |
| paravertebral block by ultra-soundTPVB will be given using high frequency linear US transducer, place the probe parallel to the vertebral spine at T2 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of plura, transverse process and paravertebral space, the needle will be inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 10ml of 0.25% bubivacine and 80mg triamcinlone slowly; the pleura will be seen to be pushed downward. | Procedure or surgery | paravertebral block |
Primary outcome
Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.
Time frame: baseline
Compare the analgesic efficacy between ultrasound paraverbral block and serratus block in chronic postmastectomy pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 19903919Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
- Background: PubMed 10506676Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.
- Background: PubMed 19488550Couceiro TC, Menezes TC, Valenca MM. Post-mastectomy pain syndrome: the magnitude of the problem. Rev Bras Anestesiol. 2009 May-Jun;59(3):358-65. doi: 10.1590/s0034-70942009000300012. English, Portuguese.
- Background: PubMed 18635381Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.
- Background: PubMed 21705873Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, del Moral-Avila R, Castro-Sanchez AM, Arroyo-Morales M. Effectiveness of a multidimensional physical therapy program on pain, pressure hypersensitivity, and trigger points in breast cancer survivors: a randomized controlled clinical trial. Clin J Pain. 2012 Feb;28(2):113-21. doi: 10.1097/AJP.0b013e318225dc02.
- Background: PubMed 24918332Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.
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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.
Mohammed Mohammed Abd El-Latif, Prof of Anesthesia study director
Mohammed MohammedAbd El-Latif
Ashraf Amin Mohammed, Prof of Anesthesia study director
Ashraf Amin Mohammed
Rania Mohammed Abd El-Emam, Lecturer of Anesthesia study director
Rania Mohammed Abd El-Emam
Questions about this trial
What is this clinical trial studying?
A study testing serratus plane block by ultra-sound and paravertebral block by ultra-sound in people with Post-mastectomy Pain Syndrome, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Abo Eldahab Ali Eldein, Resident (01068744428, totaaboeldahab8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317898, which also lists 6 linked publications.
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 15 Jul 2020.