Breast CancerNCT03319511
Thoracic Spinal Anesthesia in Awake Breast Surgery
A study testing spinal group and paravertebral group in people with Breast Cancer, run by Alaa Mazy at 1 site in Egypt.
Trial summary
General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- spinal group and paravertebral group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2014to 12 Nov 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II, III, IV patients may have:
- Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
- Lung disease (e.g., bronchial asthma, COPD)
- Renal disease (e.g., renal failure, polycystic kidney)
- Liver disease (e.g., cirrhosis, hepatitis)
- Endocrine disease (e.g., diabetes mellitus)
Who cannot join
- Patient refusal
- Contraindication to regional anesthesia (coagulopathy, local infection),
- Spinal deformities.
- An allergy to α 2 adrenergic agonist local anesthetic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery
General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good alternative to general anesthesia for breast cancer surgery, providing superior analgesia and fewer side effects related to a standard opiate-based analgesia. there is no evident optimal regional techniques for operative procedures on the breast and axilla, like high thoracic epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative stress, provides beneficial hemodynamic effects especially for critically ill patients and decreases postoperative morbidity and mortality. Also it reduces post-operative nausea and vomiting and provides prolonged post-operative sensory block, minimizing narcotic requirements. Additionally, this application positively affects the early start of feeding and mobilization.
Read the detailed description
Thoracic paravertebral block (TPVB) is an alternative method to general anesthesia for patients undergoing breast surgery, because it provides a safe anesthesia with balanced hemodynamic response with unilateral somatic and sympathetic blockade, allows postoperative analgesia lowering narcotic usage , minimal nausea and vomiting rate, early discharge and low cost.
Segmental thoracic spinal anesthesia have introduced for cardiac surgery in adults and children in the early 1990's. Kowalewski et al., performed over 10000 cases of spinal injections without a single case of spinal/epidural hematoma or any neurological complications, also segmental thoracic spinal anesthesia has been used successfully for laparoscopic cholecystectomy and abdominal surgeries. It has some advantages when compared with general anesthesia and can be a sole anesthetic in breast cancer surgery with axillary lymph node clearance especially in critical cases. Among its advantages are the quality of postoperative analgesia, lower incidence of nausea and vomiting, and shorter recovery time, with the consequent early hospital discharge. The dose of the anesthetic is exceedingly low, compared with lumbar spinal anesthesia, given the highly specific block to only certain nerve functions along a section of the cord, there is no blockade of the lower extremities. This means that a significantly larger portion of the body experiences no venal dilation, and may offer a compensatory buffer to adverse changes in blood pressure intra-operatively. there was no recorded of neurological complications.The incidence of parasthesia in a study with 300 patients subjected to thoracic spinal puncture at T10-11 was 4.67% in the cut needle group and 8.67% in the pencil point needle group, similar to that reported in lumbar spinal anesthesia.The aim of the present study is the comparison between two sole regional anesthetic techniques, thoracic para-vertebral block and segmental thoracic spinal anesthesia in breast cancer surgery especially for critically ill patients.
- Conditions
- Breast Cancer
- Being tested
- spinal group, paravertebral group
- Keywords
- thoracic spinal, awake mastectomy, paravertebral block, analgesia, ultrasound, breast cancer
- Medical subject headings
- Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal groupOther
Also called STSB
plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.
paravertebral groupOther
Also called TPVB
plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.
| Study group | Role | What they receive |
|---|---|---|
| paravertebral group | Active comparator | ultrasound guided, in sitting position, or lateral position, at T2 and T4 levels, using 22 G spinal needle, in plane technique, traversing the costo-transverse ligament Receives: Other: paravertebral group |
| spinal group | Experimental | Ultrasound guided, In the lateral decubitus or sitting position, the puncture performed via para-median approach, at the T4-T5 or T5-T6 interspace, with a 27G spinal needle. After piercing the ligamentum flavum, the needle's stylet removed and the hub observed for free flow of CSF; injection when there is a flow of clear CSF. Receives: Other: spinal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the block success rate.
in number, defined as complete sensory block in all dermatomes (T1-T6 ).
Measured: within 30 min of injection
Secondary outcomes (26)
The paravertebral onset of sensory block
tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.
Measured: 5, 10, 15, 20, 52, 30 minutes after injection.
The spinal onset of sensory block
tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.
Measured: 2, 4, 6, 8, 10, 12, 14 minutes after injection.
The power of hand grip (T1/ C8)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Measured: 5, 10, 15, 20, 52, 30 minutes after injection.
The power of wrist flexion (C8/C7)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Measured: 5, 10, 15, 20, 52, 30 minutes after injection.
The power of elbow flexion (C6/ C5)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Measured: 5, 10, 15, 20, 52, 30 minutes after injection.
The onset time of lower limb motor block (Bromage 3)
in minutes, 3= unable to move legs or feet.
Measured: 5, 10, 15, 20, 25, 30 minutes after injection.
The duration of lower limb motor block (Bromage 0)
minutes, 0= free movement of legs and feet
Measured: 30, 45, 60, 90,120, 150 minutes after injection.
Ramsey sedation scale
(1 = awake, conscious, no sedation; 2 = calm and compose; 3 = awake on verbal command; 4 = brisk response to gentle tactile stimulation; 5 = awake on vigorous shaking; 6 = unarousable).
Measured: 0 (basal), then1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Heart rate
beat/minute
Measured: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Systolic blood pressure
millimeter mercury
Measured: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Mean blood pressure
millimeter mercury
Measured: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Total ephedrine consumption
milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)
Measured: intraoperative
Total atropine consumption
milligram, Bradycardia defined as heart rate below 50 beat/minute
Measured: intraoperative
Total Midazolam consumption
milligram,
Measured: intraoperative
Hypotension episodes
in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).
Measured: Intraoperative and postoperative for 24 hours.
Bradycardia episodes
In number. Bradycardia defined as heart rate below 50 beat/minute
Measured: Intraoperative and postoperative for 24 hours.
Hypoxia episodes
In number. Hypoxia is defined as defined as respiratory rate <10 breath/ minutes or oxygen saturation less than 90%.
Measured: Intraoperative and postoperative for 24 hours.
incidence of nausea
In number.
Measured: Intraoperative and postoperative for 24 hours.
incidence of vomiting
In number.
Measured: Intraoperative and postoperative for 24 hours.
the incidence of pneumothorax.
in numbers. confirmed by plane X-ray
Measured: intraoperative and postoperative for 6 hours.
The incidence of post-dural puncture headache.
in numbers.
Measured: postoperative for 72 hours.
The duration of upper limb motor block,
minutes. starting from the time of score 3 to score 0 (0= no motor block).
Measured: 15, 30, 45, 60, 90 minutes after injection.
Visual analog scale
a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.
Measured: at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
The total mepridine consumption.
milligram
Measured: postoperative for 24 hours.
satisfaction of the patient
scale from 0-10, 10= the highest.
Measured: after 24 hours from the end of operation.
satisfaction of the surgeon
scale from 0-10, 10= the highest.
Measured: within 2 hours from the end of operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start24 Nov 2014
- Primary completion12 Nov 2016
- Study completion12 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319511
- Sponsor's protocol ID
- MD/15.05.91
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03319511
- Acronym / sponsor ID
- MD/15.05.91
- Conditions
- Breast Cancer
- Keywords
- thoracic spinal, awake mastectomy, paravertebral block, analgesia, ultrasound, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alaa MazyUniversity, hospital or other
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 12 Nov 2016 (actual)
- Study completion
- 12 Nov 2016 (actual)
- First posted
- 24 Oct 2017 (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.
General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good alternative to general anesthesia for breast cancer surgery, providing superior analgesia and fewer side effects related to a standard opiate-based analgesia. there is no evident optimal regional techniques for operative procedures on the breast and axilla, like high thoracic epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative stress, provides beneficial hemodynamic effects especially for critically ill patients and decreases postoperative morbidity and mortality. Also it reduces post-operative nausea and vomiting and provides prolonged post-operative sensory block, minimizing narcotic requirements. Additionally, this application positively affects the early start of feeding and mobilization.
Detailed description
Thoracic paravertebral block (TPVB) is an alternative method to general anesthesia for patients undergoing breast surgery, because it provides a safe anesthesia with balanced hemodynamic response with unilateral somatic and sympathetic blockade, allows postoperative analgesia lowering narcotic usage , minimal nausea and vomiting rate, early discharge and low cost.
Segmental thoracic spinal anesthesia have introduced for cardiac surgery in adults and children in the early 1990's. Kowalewski et al., performed over 10000 cases of spinal injections without a single case of spinal/epidural hematoma or any neurological complications, also segmental thoracic spinal anesthesia has been used successfully for laparoscopic cholecystectomy and abdominal surgeries. It has some advantages when compared with general anesthesia and can be a sole anesthetic in breast cancer surgery with axillary lymph node clearance especially in critical cases. Among its advantages are the quality of postoperative analgesia, lower incidence of nausea and vomiting, and shorter recovery time, with the consequent early hospital discharge. The dose of the anesthetic is exceedingly low, compared with lumbar spinal anesthesia, given the highly specific block to only certain nerve functions along a section of the cord, there is no blockade of the lower extremities. This means that a significantly larger portion of the body experiences no venal dilation, and may offer a compensatory buffer to adverse changes in blood pressure intra-operatively. there was no recorded of neurological complications.The incidence of parasthesia in a study with 300 patients subjected to thoracic spinal puncture at T10-11 was 4.67% in the cut needle group and 8.67% in the pencil point needle group, similar to that reported in lumbar spinal anesthesia.The aim of the present study is the comparison between two sole regional anesthetic techniques, thoracic para-vertebral block and segmental thoracic spinal anesthesia in breast cancer surgery especially for critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral group | Active comparator | Other: paravertebral groupultrasound guided, in sitting position, or lateral position, at T2 and T4 levels, using 22 G spinal needle, in plane technique, traversing the costo-transverse ligament |
| spinal group | Experimental | Other: spinal groupUltrasound guided, In the lateral decubitus or sitting position, the puncture performed via para-median approach, at the T4-T5 or T5-T6 interspace, with a 27G spinal needle. After piercing the ligamentum flavum, the needle's stylet removed and the hub observed for free flow of CSF; injection when there is a flow of clear CSF. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
- Lung disease (e.g., bronchial asthma, COPD)
- Renal disease (e.g., renal failure, polycystic kidney)
- Liver disease (e.g., cirrhosis, hepatitis)
- Endocrine disease (e.g., diabetes mellitus)
Key exclusion criteria (4 listed)
- Patient refusal
- Contraindication to regional anesthesia (coagulopathy, local infection),
- Spinal deformities.
- An allergy to α 2 adrenergic agonist local anesthetic drugs.
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 |
|---|---|---|
| spinal groupAlso: STSBplain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection. | Other | spinal group |
| paravertebral groupAlso: TPVBplain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels. | Other | paravertebral group |
Primary outcome
the block success rate.
Time frame: within 30 min of injection
in number, defined as complete sensory block in all dermatomes (T1-T6 ).
26 secondary outcomes
The paravertebral onset of sensory block
Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.
The spinal onset of sensory block
Time frame: 2, 4, 6, 8, 10, 12, 14 minutes after injection.
The power of hand grip (T1/ C8)
Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.
The power of wrist flexion (C8/C7)
Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.
The power of elbow flexion (C6/ C5)
Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.
The onset time of lower limb motor block (Bromage 3)
Time frame: 5, 10, 15, 20, 25, 30 minutes after injection.
The duration of lower limb motor block (Bromage 0)
Time frame: 30, 45, 60, 90,120, 150 minutes after injection.
Ramsey sedation scale
Time frame: 0 (basal), then1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Heart rate
Time frame: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Systolic blood pressure
Time frame: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Mean blood pressure
Time frame: 0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Total ephedrine consumption
Time frame: intraoperative
Total atropine consumption
Time frame: intraoperative
Total Midazolam consumption
Time frame: intraoperative
Hypotension episodes
Time frame: Intraoperative and postoperative for 24 hours.
Bradycardia episodes
Time frame: Intraoperative and postoperative for 24 hours.
Hypoxia episodes
Time frame: Intraoperative and postoperative for 24 hours.
incidence of nausea
Time frame: Intraoperative and postoperative for 24 hours.
incidence of vomiting
Time frame: Intraoperative and postoperative for 24 hours.
the incidence of pneumothorax.
Time frame: intraoperative and postoperative for 6 hours.
The incidence of post-dural puncture headache.
Time frame: postoperative for 72 hours.
The duration of upper limb motor block,
Time frame: 15, 30, 45, 60, 90 minutes after injection.
Visual analog scale
Time frame: at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
The total mepridine consumption.
Time frame: postoperative for 24 hours.
satisfaction of the patient
Time frame: after 24 hours from the end of operation.
satisfaction of the surgeon
Time frame: within 2 hours from the end of operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal group and paravertebral group in people with Breast Cancer, run by Alaa Mazy 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 24 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the block success rate. (time frame: within 30 min of injection). 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 24 Oct 2017.