Thoracic Spinal Anesthesia in Awake Breast Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: spinal group
* Other: paravertebral group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paravertebral group<br>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 | Other: paravertebral group<br>* plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.<br>* Other names: TPVB;|
| Experimental: spinal group<br>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. | Other: spinal group<br>* plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.<br>* Other names: STSB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the block success rate. | in number, defined as complete sensory block in all dermatomes (T1-T6 ). | within 30 min of injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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). | 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 | 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 | 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 | 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) | intraoperative | 
| Total atropine consumption | milligram, Bradycardia defined as heart rate below 50 beat/minute | intraoperative | 
| Total Midazolam consumption | milligram, | intraoperative | 
| Hypotension episodes | in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg). | Intraoperative and postoperative for 24 hours. | 
| Bradycardia episodes | In number. Bradycardia defined as heart rate below 50 beat/minute | 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%. | Intraoperative and postoperative for 24 hours. | 
| incidence of nausea | In number. | Intraoperative and postoperative for 24 hours. | 
| incidence of vomiting | In number. | Intraoperative and postoperative for 24 hours. | 
| the incidence of pneumothorax. | in numbers. confirmed by plane X-ray | intraoperative and postoperative for 6 hours. | 
| The incidence of post-dural puncture headache. | in numbers. | 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). | 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. | at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative. | 
| The total mepridine consumption. | milligram | postoperative for 24 hours. | 
| satisfaction of the patient | scale from 0-10, 10= the highest. | after 24 hours from the end of operation. | 
| satisfaction of the surgeon | scale from 0-10, 10= the highest. | within 2 hours from the end of operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic spinal, awake mastectomy, paravertebral block, analgesia, ultrasound, breast cancer