Oncolgy Center, Mansoura University,
Al Mansurah, DK, 35516, Egypt
NCT Number: NCT03319511
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.
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Notify Me35 year–70 year
Female
Interventional
Not applicable
Al Mansurah, DK, 35516, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ASA II, III, IV patients may have:
Exclusion criteria
plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.
Other names: STSB
plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.
Other names: TPVB
Time frame: within 30 min of injection
in number, defined as complete sensory block in all dermatomes (T1-T6 ).
Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.
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.
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.
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.
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.
four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.
Time frame: 5, 10, 15, 20, 25, 30 minutes after injection.
in minutes, 3= unable to move legs or feet.
Time frame: 30, 45, 60, 90,120, 150 minutes after injection.
minutes, 0= free movement of legs and feet
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.
(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, 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.
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.
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.
millimeter mercury
Time frame: intraoperative
milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)
Time frame: intraoperative
milligram, Bradycardia defined as heart rate below 50 beat/minute
Time frame: intraoperative
milligram,
Time frame: Intraoperative and postoperative for 24 hours.
in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).
Time frame: Intraoperative and postoperative for 24 hours.
In number. Bradycardia defined as heart rate below 50 beat/minute
Time frame: Intraoperative and postoperative for 24 hours.
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.
In number.
Time frame: Intraoperative and postoperative for 24 hours.
In number.
Time frame: intraoperative and postoperative for 6 hours.
in numbers. confirmed by plane X-ray
Time frame: postoperative for 72 hours.
in numbers.
Time frame: 15, 30, 45, 60, 90 minutes after injection.
minutes. starting from the time of score 3 to score 0 (0= no motor block).
Time frame: at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.
Time frame: postoperative for 24 hours.
milligram
Time frame: after 24 hours from the end of operation.
scale from 0-10, 10= the highest.
Time frame: within 2 hours from the end of operation.
scale from 0-10, 10= the highest.
Alaa Mazy
Other
Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery
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