Clinical trial NCT03319511: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: thoracic spinal
awake mastectomy
paravertebral block
analgesia
ultrasound
breast cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the block success rate.
timeFrame: within 30 min of injection
Secondary outcomes:
measure: The paravertebral onset of sensory block
timeFrame: 5, 10, 15, 20, 52, 30 minutes after injection.
measure: The spinal onset of sensory block
timeFrame: 2, 4, 6, 8, 10, 12, 14 minutes after injection.
measure: The power of hand grip (T1/ C8)
timeFrame: 5, 10, 15, 20, 52, 30 minutes after injection.
measure: The power of wrist flexion (C8/C7)
timeFrame: 5, 10, 15, 20, 52, 30 minutes after injection.
measure: The power of elbow flexion (C6/ C5)
timeFrame: 5, 10, 15, 20, 52, 30 minutes after injection.
measure: The onset time of lower limb motor block (Bromage 3)
timeFrame: 5, 10, 15, 20, 25, 30 minutes after injection.
measure: The duration of lower limb motor block (Bromage 0)
timeFrame: 30, 45, 60, 90,120, 150 minutes after injection.
measure: Ramsey sedation scale
timeFrame: 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.
measure: Heart rate
timeFrame: 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.
measure: Systolic blood pressure
timeFrame: 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.
measure: Mean blood pressure
timeFrame: 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.
measure: Total ephedrine consumption
timeFrame: intraoperative
measure: Total atropine consumption
timeFrame: intraoperative
measure: Total Midazolam consumption
timeFrame: intraoperative
measure: Hypotension episodes
timeFrame: Intraoperative and postoperative for 24 hours.
measure: Bradycardia episodes
timeFrame: Intraoperative and postoperative for 24 hours.
measure: Hypoxia episodes
timeFrame: Intraoperative and postoperative for 24 hours.
measure: incidence of nausea
timeFrame: Intraoperative and postoperative for 24 hours.
measure: incidence of vomiting
timeFrame: Intraoperative and postoperative for 24 hours.
measure: the incidence of pneumothorax.
timeFrame: intraoperative and postoperative for 6 hours.
measure: The incidence of post-dural puncture headache.
timeFrame: postoperative for 72 hours.
measure: The duration of upper limb motor block,
timeFrame: 15, 30, 45, 60, 90 minutes after injection.
measure: Visual analog scale
timeFrame: at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
measure: The total mepridine consumption.
timeFrame: postoperative for 24 hours.
measure: satisfaction of the patient
timeFrame: after 24 hours from the end of operation.
measure: satisfaction of the surgeon
timeFrame: within 2 hours from the end of operation.
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Oncolgy Center, Mansoura University,
state: DK
Study officials:
References: