Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy PainNCT04498234
Comparison Between U\S Guided Erector Spinaeblock and Paravertebral Block on Acute and Chronic Post Mastectomy Pain
A study testing ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % in people with Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
compare between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block on acute and chronic post mastectomy pain Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy Pain
- What is being tested?
- ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Dec 2023
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender : female .
- Age : 20 to 70 years old .
- Scheduled for : either left or right modified radical mastectomy (MRM)
- Physical status : American society of anesthesiologists (ASA) physical status I and II.
Who cannot join
- 1-ASA > III 2 -age> 70 years old. 3-patients refusal to the procedure. 4-Infection of the skin at or near site of needle puncture. 5- Coagulopathy . 6- Drug hypersensitivity or allergy to the studied drugs. 7- Central or peripheral neuropthy . 8-Pre-operative opoid consumption ( within 24 hours preoperative ) 9- Anomalies of the vertebral column .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 171516
Romany G. Naeem, MSc, 1006231332 ext. 0020, Romanytreka22@gmail.com
About this study
Official title: Comparison Between Ultrasound Guided Erector Spinae Plane Block and Paravertebral Block on Acute and Chronic Postmastectomy Pain
compare between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block on acute and chronic post mastectomy pain
Read the detailed description
Management of postoperative analgesia following breast surgery extending beyond a simple lumpectomy can sometimes be a challenge, especially when such surgery is being performed as a day-case procedure. Patients undergoing mastectomy have a very high possibility of developing postsurgical pain syndrome, as high as 20% to 50%.There has been some evidence to suggest regional analgesia techniques reduce the incidence of postsurgical pain in patients undergoing mastectomy. This underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery.There are many techniques of regional analgesia as thorasic epidural block , paravertebral block , PECS1 block ,PECS2 block , and recently erector spinae plan block.Paravertebral 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.TPVB produces ipsilateral somatic and sympathetic nerve blockade due to a direct effect of the local anesthetic on the somatic and sympathetic nerves in the TPVS, extension into the intercostal space laterally, and the epidural space medially. Ultrasound-guided erector spinae plane (US-ESP) block is a novel analgesic technique, in which local anaesthetic is injected into fascial plane deep to erector spinae muscle. It is possible to block the dorsal and ventral rami of the spinal nerve depending on the level of injection and amount of local anaesthetic injected. Erector spinae block (ESP) leads to effective post-operative analgesia where it is performed at T4-5 level for breast cancer and thoracic surgery , when performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.The drug spreads in craniocaudal fashion over several levels as the erector spinae fascia extends from nuchal fascia cranially to the sacrum caudally. Forero et al. recently described US-ESP block for thoracic neuropathic pain. This block could be effective in both acute post-operative thoracic and abdominal surgeries and also neuropathic pain in these regions.
- Being tested
- ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %Procedure or surgery
One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
| Study group | Role | What they receive |
|---|---|---|
| GROUP(A) (CONTROL GROUP) | Experimental | Patients will receive standard regimen of anesthesia . Receives: Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % |
| Group B | Experimental | Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4. Receives: Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % |
| Group C | Experimental | Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space . Receives: Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic requirement
Total morphine consumption during first 24 hours post operatively.
Measured: 24 hours
Secondary outcomes (2)
stress response
Effect on stress response: serum level of cortisol and noradrenaline (immediately preoperative, after intubation, immediately postoperative, and after 24 hours postoperative)
Measured: 24 hours
Chronic post mastectomy pain
Chronic post mastectomy will be assessed at pain clinic at 1st, 3rd, 6 th month postoperatively using (LANSS ) score .
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 May 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Gergis Naeem Gendy, South Egypt Cancer Institute
- Investigators
- Romany G. Naeem, MSc, Principal investigator, assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498234
- Sponsor's protocol ID
- Romany SECI
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4.
PubMed 39574036
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Erector Spinae Plane Block and Paravertebral Block on Acute and Chronic Postmastectomy Pain
- ClinicalTrials.gov ID
- NCT04498234
- Acronym / sponsor ID
- Romany SECI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Aug 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 between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block on acute and chronic post mastectomy pain
Detailed description
Management of postoperative analgesia following breast surgery extending beyond a simple lumpectomy can sometimes be a challenge, especially when such surgery is being performed as a day-case procedure. Patients undergoing mastectomy have a very high possibility of developing postsurgical pain syndrome, as high as 20% to 50%.There has been some evidence to suggest regional analgesia techniques reduce the incidence of postsurgical pain in patients undergoing mastectomy. This underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery.There are many techniques of regional analgesia as thorasic epidural block , paravertebral block , PECS1 block ,PECS2 block , and recently erector spinae plan block.Paravertebral 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.TPVB produces ipsilateral somatic and sympathetic nerve blockade due to a direct effect of the local anesthetic on the somatic and sympathetic nerves in the TPVS, extension into the intercostal space laterally, and the epidural space medially. Ultrasound-guided erector spinae plane (US-ESP) block is a novel analgesic technique, in which local anaesthetic is injected into fascial plane deep to erector spinae muscle. It is possible to block the dorsal and ventral rami of the spinal nerve depending on the level of injection and amount of local anaesthetic injected. Erector spinae block (ESP) leads to effective post-operative analgesia where it is performed at T4-5 level for breast cancer and thoracic surgery , when performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.The drug spreads in craniocaudal fashion over several levels as the erector spinae fascia extends from nuchal fascia cranially to the sacrum caudally. Forero et al. recently described US-ESP block for thoracic neuropathic pain. This block could be effective in both acute post-operative thoracic and abdominal surgeries and also neuropathic pain in these regions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP(A) (CONTROL GROUP) | Experimental | Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %Patients will receive standard regimen of anesthesia . |
| Group B | Experimental | Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4. |
| Group C | Experimental | Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space . |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender : female .
- Age : 20 to 70 years old .
- Scheduled for : either left or right modified radical mastectomy (MRM)
- Physical status : American society of anesthesiologists (ASA) physical status I and II.
Key exclusion criteria (1 listed)
- 1-ASA > III 2 -age> 70 years old. 3-patients refusal to the procedure. 4-Infection of the skin at or near site of needle puncture. 5- Coagulopathy . 6- Drug hypersensitivity or allergy to the studied drugs. 7- Central or peripheral neuropthy . 8-Pre-operative opoid consumption ( within 24 hours preoperative ) 9- Anomalies of the vertebral column .
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 |
|---|---|---|
| ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space . | Procedure or surgery | GROUP(A) (CONTROL GROUP), Group B, Group C |
Primary outcome
analgesic requirement
Time frame: 24 hours
Total morphine consumption during first 24 hours post operatively.
2 secondary outcomes
stress response
Time frame: 24 hours
Chronic post mastectomy pain
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39574036Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4.
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.
Romany G. Naeem, MSc principal investigator
assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % in people with Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
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 1 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 31 Oct 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romany G. Naeem, MSc (1006231332 ext. 0020, Romanytreka22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic requirement (time frame: 24 hours). 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 NCT04498234, which also lists 1 linked publication.
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 31 Oct 2023.