Post Mastectomy Pain SyndromeNCT02641951
Stellate Ganglionic Block Versus Stellate Ganglionic Block Plus Pecs II Block for Mastectomy Pain
A study testing Stellate ganglionic block and Pecs II block in people with Post Mastectomy Pain Syndrome and After Breast Surgery, run by Mansoura University.
Trial summary
Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. 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, After Breast Surgery
- What is being tested?
- Stellate ganglionic block and Pecs II block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status III or IV.
- Patients having irradiating pain of anterior chest wall and axilla after breast surgery.
- Patients having irradiating pain of ipsilateral arm after breast surgery
- Pain not responding to conservative treatment
- Pain persisting for more than 3 month
Who cannot join
- Local skin infection
- Coagulation or blood disease
- Pregnancy
- Postpartum or lactating females
- Allergy to the study medications.
- Severely altered consciousness level.
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- Psychiatric disorder
- Drug abuse
- Spine or chest wall deformities
About this study
Official title: Stellate Ganglionic Block Versus Combined Stellate Ganglionic Block and Modified Pectoral Nerve Block in Treatment of Post Mastectomy Pain Syndrome.
Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A second version of the pectoral nerve block is described, called ''modified Pecs block'' or Pecs block type II.
This novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to provide complete analgesia during breast surgery
Read the detailed description
The aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs II block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used.
All patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. Written informed consents will be obtained before the procedure.
With each block, an intravenous cannula will be inserted and secured. All suitable resuscitation equipment and drugs will be available. Vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. Midazolam 0.02 ug/kg will be administered intravenously as premedication.
Brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status.
All patients will be familiar with the use of 10-cm visual analogue scale score (VAS) identifying 0 as no pain and 10 as worst imaginable pain.Basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete Quality of life questionnaire
- Being tested
- Stellate ganglionic block, Pecs II block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglionic blockOther
Ultrasound guided stellate ganglionic block
Pecs II blockOther
Ultrasound guided Pecs II block
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglionic block | Placebo comparator | Ultrasound guided stellate ganglionic block Receives: Other: Stellate ganglionic block |
| Pecs II block | Active comparator | Ultrasound guided Pecs II block Receives: Other: Pecs II block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
100 mm- visual analog pain scale
Measured: for six months after the procedure
Secondary outcomes (2)
The range of motion of the glenohumeral joint
Improvements in the range of motion of the glenohumeral joint, which included forward extension and external rotation will be recorded using scoring system score 0 to 9 for some movements range and 0 to 160 for others
Measured: for six months after the procedure
The quality of life score
The quality of life will be assessed using the score QOLSF 36
Measured: for six 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 posted30 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy Pain SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zenat E Mohamed, MD, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, EgyptReem A Sharkawy, MD, Study director, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641951
- Sponsor's protocol ID
- R/15.08.41
- Status last verified
- Feb 2016
- First submitted
- 24 Dec 2015
- Last updated
- 9 Feb 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 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglionic Block Versus Combined Stellate Ganglionic Block and Modified Pectoral Nerve Block in Treatment of Post Mastectomy Pain Syndrome.
- ClinicalTrials.gov ID
- NCT02641951
- Acronym / sponsor ID
- R/15.08.41
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 30 Dec 2015 (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.
Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A second version of the pectoral nerve block is described, called ''modified Pecs block'' or Pecs block type II.
This novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to provide complete analgesia during breast surgery
Detailed description
The aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs II block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used.
All patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. Written informed consents will be obtained before the procedure.
With each block, an intravenous cannula will be inserted and secured. All suitable resuscitation equipment and drugs will be available. Vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. Midazolam 0.02 ug/kg will be administered intravenously as premedication.
Brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status.
All patients will be familiar with the use of 10-cm visual analogue scale score (VAS) identifying 0 as no pain and 10 as worst imaginable pain.Basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete Quality of life questionnaire
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglionic block | Placebo comparator | Other: Stellate ganglionic blockUltrasound guided stellate ganglionic block |
| Pecs II block | Active comparator | Other: Pecs II blockUltrasound guided Pecs II block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists physical status III or IV.
- Patients having irradiating pain of anterior chest wall and axilla after breast surgery.
- Patients having irradiating pain of ipsilateral arm after breast surgery
- Pain not responding to conservative treatment
- Pain persisting for more than 3 month
Key exclusion criteria (9 listed)
- Local skin infection
- Coagulation or blood disease
- Pregnancy
- Postpartum or lactating females
- Allergy to the study medications.
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 |
|---|---|---|
| Stellate ganglionic blockUltrasound guided stellate ganglionic block | Other | Stellate ganglionic block |
| Pecs II blockUltrasound guided Pecs II block | Other | Pecs II block |
Primary outcome
Pain scores
Time frame: for six months after the procedure
100 mm- visual analog pain scale
2 secondary outcomes
The range of motion of the glenohumeral joint
Time frame: for six months after the procedure
The quality of life score
Time frame: for six months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Post Mastectomy Pain Syndrome
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Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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Super-voltage PRF of Stellate Ganglion Versus Super-voltage PRF of T2 T3 Sympathetic Ganglia in Managing PMPS.
Post Mastectomy Pain Syndrome, Chronic Pain Following Surgical Procedure for Cancer
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Dex & Mastectomy Pain
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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.
Zenat E Mohamed, MD study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Reem A Sharkawy, MD study director
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglionic block and Pecs II block in people with Post Mastectomy Pain Syndrome and After Breast Surgery, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 9 Feb 2016. 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. 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 six months after the procedure). 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 9 Feb 2016.