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Thoracic Spinal Anesthesia in Awake Breast Surgery

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
spinal group
paravertebral group
Sponsored by
Alaa Mazy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring thoracic spinal, awake mastectomy, paravertebral block, analgesia, ultrasound, breast cancer

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

ASA II, III, IV patients may have:

  1. Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
  2. Lung disease (e.g., bronchial asthma, COPD)
  3. Renal disease (e.g., renal failure, polycystic kidney)
  4. Liver disease (e.g., cirrhosis, hepatitis)
  5. Endocrine disease (e.g., diabetes mellitus)

Exclusion Criteria:

  1. Patient refusal
  2. Contraindication to regional anesthesia (coagulopathy, local infection),
  3. Spinal deformities.
  4. An allergy to α 2 adrenergic agonist local anesthetic drugs.

Sites / Locations

  • Oncolgy Center, Mansoura University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

paravertebral group

spinal group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

the block success rate.
in number, defined as complete sensory block in all dermatomes (T1-T6 ).

Secondary Outcome Measures

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.
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.
The power of hand grip (T1/ C8)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
The power of wrist flexion (C8/C7)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
The power of elbow flexion (C6/ C5)
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
The onset time of lower limb motor block (Bromage 3)
in minutes, 3= unable to move legs or feet.
The duration of lower limb motor block (Bromage 0)
minutes, 0= free movement of legs and feet
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).
Heart rate
beat/minute
Systolic blood pressure
millimeter mercury
Mean blood pressure
millimeter mercury
Total ephedrine consumption
milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)
Total atropine consumption
milligram, Bradycardia defined as heart rate below 50 beat/minute
Total Midazolam consumption
milligram,
Hypotension episodes
in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).
Bradycardia episodes
In number. Bradycardia defined as heart rate below 50 beat/minute
Hypoxia episodes
In number. Hypoxia is defined as defined as respiratory rate <10 breath/ minutes or oxygen saturation less than 90%.
incidence of nausea
In number.
incidence of vomiting
In number.
the incidence of pneumothorax.
in numbers. confirmed by plane X-ray
The incidence of post-dural puncture headache.
in numbers.
The duration of upper limb motor block,
minutes. starting from the time of score 3 to score 0 (0= no motor block).
Visual analog scale
a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.
The total mepridine consumption.
milligram
satisfaction of the patient
scale from 0-10, 10= the highest.
satisfaction of the surgeon
scale from 0-10, 10= the highest.

Full Information

First Posted
October 16, 2017
Last Updated
October 19, 2017
Sponsor
Alaa Mazy
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1. Study Identification

Unique Protocol Identification Number
NCT03319511
Brief Title
Thoracic Spinal Anesthesia in Awake Breast Surgery
Official Title
Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 24, 2014 (Actual)
Primary Completion Date
November 12, 2016 (Actual)
Study Completion Date
November 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mazy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
thoracic spinal, awake mastectomy, paravertebral block, analgesia, ultrasound, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
a dorsal thoracic gauze cover.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paravertebral group
Arm Type
Active Comparator
Arm Description
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
Arm Title
spinal group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
spinal group
Other Intervention Name(s)
STSB
Intervention Description
plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.
Intervention Type
Other
Intervention Name(s)
paravertebral group
Other Intervention Name(s)
TPVB
Intervention Description
plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.
Primary Outcome Measure Information:
Title
the block success rate.
Description
in number, defined as complete sensory block in all dermatomes (T1-T6 ).
Time Frame
within 30 min of injection
Secondary Outcome Measure Information:
Title
The paravertebral onset of sensory block
Description
tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.
Time Frame
5, 10, 15, 20, 52, 30 minutes after injection.
Title
The spinal onset of sensory block
Description
tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.
Time Frame
2, 4, 6, 8, 10, 12, 14 minutes after injection.
Title
The power of hand grip (T1/ C8)
Description
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Time Frame
5, 10, 15, 20, 52, 30 minutes after injection.
Title
The power of wrist flexion (C8/C7)
Description
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Time Frame
5, 10, 15, 20, 52, 30 minutes after injection.
Title
The power of elbow flexion (C6/ C5)
Description
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Time Frame
5, 10, 15, 20, 52, 30 minutes after injection.
Title
The onset time of lower limb motor block (Bromage 3)
Description
in minutes, 3= unable to move legs or feet.
Time Frame
5, 10, 15, 20, 25, 30 minutes after injection.
Title
The duration of lower limb motor block (Bromage 0)
Description
minutes, 0= free movement of legs and feet
Time Frame
30, 45, 60, 90,120, 150 minutes after injection.
Title
Ramsey sedation scale
Description
(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).
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.
Title
Heart rate
Description
beat/minute
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.
Title
Systolic blood pressure
Description
millimeter mercury
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.
Title
Mean blood pressure
Description
millimeter mercury
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.
Title
Total ephedrine consumption
Description
milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)
Time Frame
intraoperative
Title
Total atropine consumption
Description
milligram, Bradycardia defined as heart rate below 50 beat/minute
Time Frame
intraoperative
Title
Total Midazolam consumption
Description
milligram,
Time Frame
intraoperative
Title
Hypotension episodes
Description
in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).
Time Frame
Intraoperative and postoperative for 24 hours.
Title
Bradycardia episodes
Description
In number. Bradycardia defined as heart rate below 50 beat/minute
Time Frame
Intraoperative and postoperative for 24 hours.
Title
Hypoxia episodes
Description
In number. Hypoxia is defined as defined as respiratory rate <10 breath/ minutes or oxygen saturation less than 90%.
Time Frame
Intraoperative and postoperative for 24 hours.
Title
incidence of nausea
Description
In number.
Time Frame
Intraoperative and postoperative for 24 hours.
Title
incidence of vomiting
Description
In number.
Time Frame
Intraoperative and postoperative for 24 hours.
Title
the incidence of pneumothorax.
Description
in numbers. confirmed by plane X-ray
Time Frame
intraoperative and postoperative for 6 hours.
Title
The incidence of post-dural puncture headache.
Description
in numbers.
Time Frame
postoperative for 72 hours.
Title
The duration of upper limb motor block,
Description
minutes. starting from the time of score 3 to score 0 (0= no motor block).
Time Frame
15, 30, 45, 60, 90 minutes after injection.
Title
Visual analog scale
Description
a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.
Time Frame
at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
Title
The total mepridine consumption.
Description
milligram
Time Frame
postoperative for 24 hours.
Title
satisfaction of the patient
Description
scale from 0-10, 10= the highest.
Time Frame
after 24 hours from the end of operation.
Title
satisfaction of the surgeon
Description
scale from 0-10, 10= the highest.
Time Frame
within 2 hours from the end of operation.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Patient refusal Contraindication to regional anesthesia (coagulopathy, local infection), Spinal deformities. An allergy to α 2 adrenergic agonist local anesthetic drugs.
Facility Information:
Facility Name
Oncolgy Center, Mansoura University,
City
Mansourah
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
after publication, for no limit
IPD Sharing Access Criteria
e mail: alaa_mazy@yahoo.com

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Thoracic Spinal Anesthesia in Awake Breast Surgery

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