Modified Radical MastectomyNCT02839083
Pecs II Block as Alternative for Paravertebral Block in Modified Radical Mastectomy
A study testing Thoracic Paravertebral group and Pecs II group in people with Modified Radical Mastectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- Thoracic Paravertebral group and Pecs II group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Dec 2016
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Association for Anesthesiologists physical status I or II
- Body mass index > 40 kg/m2
Who cannot join
- Patient refusal
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Significant endocrinal disease.
- Pregnancy.
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- Postpartum period.
- Lactating females.
- Allergy to any of the study medication.
- Coagulation disorders.
- Infection at the site of needle insertion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Paravertebral Block Versus Pecs II Block for Perioperative Analgesia in Modified Radical Mastectomy
Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.
Read the detailed description
Various modalities have been used for perioperative pain management in relevance to breast surgery. Thoracic epidural and paravertebral blocks (PVB) became the gold standard techniques to achieve this goal. However, both techniques may be associated with devastating complications such as spinal cord injury, total spinal anesthesia, inadvertent intravascular injection and pneumothorax.
On the other hand, the advancement of ultrasound (US) technology and our ability to visualize the pleura and other structures in and around the paravertebral space has increased interest in performing thoracic paravertebral blocks guided by US.
"Pecs" block is a less invasive procedure involving US guided interfascial injections has been suggested as potential alternative analgesic technique. The Pecs I block was initially described by Blanco for minor breast surgery. A year later, on 2012, he described a Pecs II block or "modified Pecs block" for breast surgery involving the axilla.
The Pecs I block targets the medial pectoral nerve (MPN) from C8 and T1 and the lateral pectoral nerve (LPN) from C5, C6, and C7. These nerves arise from the medial and lateral cords of the brachial plexus, respectively, and innervate the pectoralis muscles.
The Pecs II block targets the T2-6 intercostal nerves, the long thoracic nerve which supplies the serratus anterior, and the thoracodorsal nerve which supplies the latissimus dorsi. Potential complications include accidental intravascular injection and pneumothorax.
The easily identifiable landmarks allow this block to provide a simple alternative to paravertebral and neuraxial blocks for breast surgery. The block produces excellent analgesia and can be used as a rescue block in cases with patchy or ineffective paravertebral or epidural block.
- Conditions
- Modified Radical Mastectomy
- Being tested
- Thoracic Paravertebral group, Pecs II group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Paravertebral groupOther
Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml
Pecs II groupOther
Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Paravertebral group | Placebo comparator | Ultrasound guided thoracic paravertebral block Receives: Other: Thoracic Paravertebral group |
| Pecs II group | Active comparator | Ultrasound guided Pecs II block Receives: Other: Pecs II group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain visual analog scale is used to assess the severity of postoperative pain
Measured: For 24 hours after surgery
Secondary outcomes (2)
Duration of postoperative analgesia
period from completion of the block to time of administration of the first rescue analgesic for 12 hour after performing the block
Measured: for 12 hours after surgery
Cumulative postoperative meperidine consumption
Cumulative consumption of rescue meperidine analgesic for 24 hours
Measured: for 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startApr 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abd-Elaziz Metawa, MD, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839083
- Sponsor's protocol ID
- MD ∕ 153
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block Versus Pecs II Block for Perioperative Analgesia in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT02839083
- Acronym / sponsor ID
- MD ∕ 153
- Conditions
- Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- 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.
Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.
Detailed description
Various modalities have been used for perioperative pain management in relevance to breast surgery. Thoracic epidural and paravertebral blocks (PVB) became the gold standard techniques to achieve this goal. However, both techniques may be associated with devastating complications such as spinal cord injury, total spinal anesthesia, inadvertent intravascular injection and pneumothorax.
On the other hand, the advancement of ultrasound (US) technology and our ability to visualize the pleura and other structures in and around the paravertebral space has increased interest in performing thoracic paravertebral blocks guided by US.
"Pecs" block is a less invasive procedure involving US guided interfascial injections has been suggested as potential alternative analgesic technique. The Pecs I block was initially described by Blanco for minor breast surgery. A year later, on 2012, he described a Pecs II block or "modified Pecs block" for breast surgery involving the axilla.
The Pecs I block targets the medial pectoral nerve (MPN) from C8 and T1 and the lateral pectoral nerve (LPN) from C5, C6, and C7. These nerves arise from the medial and lateral cords of the brachial plexus, respectively, and innervate the pectoralis muscles.
The Pecs II block targets the T2-6 intercostal nerves, the long thoracic nerve which supplies the serratus anterior, and the thoracodorsal nerve which supplies the latissimus dorsi. Potential complications include accidental intravascular injection and pneumothorax.
The easily identifiable landmarks allow this block to provide a simple alternative to paravertebral and neuraxial blocks for breast surgery. The block produces excellent analgesia and can be used as a rescue block in cases with patchy or ineffective paravertebral or epidural block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Paravertebral group | Placebo comparator | Other: Thoracic Paravertebral groupUltrasound guided thoracic paravertebral block |
| Pecs II group | Active comparator | Other: Pecs II groupUltrasound guided Pecs II block |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Association for Anesthesiologists physical status I or II
- Body mass index > 40 kg/m2
Key exclusion criteria (11 listed)
- Patient refusal
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Significant endocrinal disease.
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 |
|---|---|---|
| Thoracic Paravertebral groupThoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml | Other | Thoracic Paravertebral group |
| Pecs II groupUltrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml | Other | Pecs II group |
Primary outcome
Pain scores
Time frame: For 24 hours after surgery
Pain visual analog scale is used to assess the severity of postoperative pain
2 secondary outcomes
Duration of postoperative analgesia
Time frame: for 12 hours after surgery
Cumulative postoperative meperidine consumption
Time frame: for 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Abd-Elaziz Metawa, MD study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Paravertebral group and Pecs II group in people with Modified Radical Mastectomy, run by Mansoura University 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 2 inclusion and 11 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 20 Jul 2016. 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. Some participants in this study may receive a placebo. 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?
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?
Pain scores (time frame: For 24 hours after 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 20 Jul 2016.